Medical Device Registration Timeline

Class I registration reviewed within 5 working days of a complete application (Law No. 89/2018 on medical devices)

Class II registration reviewed within 30 working days of a complete application (Law No. 89/2018)

Class III registration reviewed within 30 working days of a complete application (Law No. 89/2018)

Décret exécutif 20-324 Art. 30: the ANPP must decide within 240 days from the date the file is ruled admissible under Art. 22, and the director general may exceptionally extend that by up to 90 days, which is where the 330-day upper bound comes from

The clock is suspended whenever complementary information is requested, and an application lapses outright if the applicant misses the deadline set for supplying it

The decree states one homologation clock and does not allocate separate clocks by risk class

Arrêté of 23 June 2021 Art. 9: the ANPP must decide within 90 days from admissibility, exceptionally extendable by the director general by up to 30 days

Art. 8 places an internal 60-day step inside that window, within which the dossier and technical evaluation reports must reach the homologation commission, itself extendable by 30 days when complementary information is requested

This route exists because Décret 20-324 Art. 16 carved export-only local manufacture out of the general homologation regime and left it to a ministerial arrêté

A rejected applicant may appeal to the ANPP within 30 days of notification

Arrêté of 23 June 2021 Art. 12: the ANPP must decide within 90 days from receipt of the modification request, exceptionally extendable by the director general by up to 30 days, with the clock suspended while complementary information is outstanding

Art. 9 applies the same 8-day admissibility examination used for original homologation, and an incomplete modification file is declared inadmissible

Art. 14 and 15: after a rejection the holder has 30 days to file a corrected request, which the ANPP must then decide within 30 days

Art. 4: Class I devices that are not sterile, have no measuring function and are not active, and appear in Annex II Part A, file a sworn declaration; the INPM endorsement at the moment of receipt is itself the RPPTM registration record, so no review period runs

The realistic range is dossier preparation and company-licensing lead time, not regulator review

Art. 5: the INPM has 15 administrative working days to assess the dossier and rule

Art. 7 allows a single consolidated deficiency notice; the applicant then has 30 administrative working days to respond and the review period is suspended meanwhile

Art. 5: the INPM has 15 administrative working days to assess the dossier and rule

Since 16 Feb 2026 an imported Class II device authorised in a Decreto 892/2025 Annex I country can instead use the prior-notification route, which takes effect on filing

Art. 6: ANMAT has 110 administrative working days to assess the dossier and issue the administrative act

Art. 7 suspends that period while the applicant answers the single consolidated deficiency notice, which is why the realistic range is far longer

Art. 6: Class IV runs on the same 110 administrative working days as Class III

Extensive clinical evidence and an on-site audit are possible, and art. 7 suspends the period during the deficiency response

Paragraph 50 of the Rules (Annex No. 2 to EEC Council Decision No. 46 of 12 February 2016, as restated by EEC Council Decision No. 144 of 24 December 2021): 'The authorized authority (expert organization) of the Member State concerned shall consider the expert report within 30 business days, calculated from one of the following dates: when the procedures of marketing authorization and expert examination of a medical device are carried out – from the date of receipt of a notice on payment for the approval procedures by the authorized bodies (expert organizations) of the reference Member State and the Member State(s) concerned'. Recorded in working-days, the same measure as the text's 'business days'.

This replaces the earlier note on this row that no published clock had been found: the Rules do fix a clock for Armenia's own market-access decision, and paragraph 50 is it. It is the tail of the procedure rather than the whole of it — paragraphs 28, 29, 30, 31, 32, 35, 36 and 40 clock the applicant, the reference Member State and its inspecting organisation on the earlier stages.

The start trigger is not the application date: the 30 business days runs from receipt of the payment notice and of the applicant's funds in the Member State concerned's account, so an unpaid approval fee stops the period. The applicant's own 60-business-day response window (paragraph 28) and 30-calendar-day payment window (paragraph 36) sit outside it.

The class split matters for the duty, not for the clock: the Law on State Duty prices these devices at AMD 10,000 and AMD 20,000 respectively.

Same paragraph 50 clock as the lower classes — 30 business days for the authorised authority of the Member State concerned to consider the expert report — because paragraph 50 is class-neutral. The class distinction in Chapter II operates on whether a production-facility audit is required, not on the consideration period.

The class-dependent stage is the audit, which paragraph 30 puts at not more than 90 business days from the reference Member State's decision to start it, with the audit report due within 15 business days of completion (paragraph 31) and the expert report within 15 business days of the audit report (paragraph 32). All of those bind the reference Member State or its inspecting organisation, not Armenia, so a class 2b or class 3 file reaches Armenia's 30-business-day consideration later than a class 1 or class 2a file, but the consideration itself is the same period.

State-duty rates for these devices are AMD 20,000 (class 2b, priced in the class 2 band) and AMD 30,000 (class 3).

Paragraph 29 of the Rules, Chapter II: 'The authorized authority (expert organization) of the reference Member State shall, within 45 business days from the date of its decision to start the marketing authorization and expert examination procedures in respect of the medical device, draw up an expert report in accordance with Annex 5 or, if required, makes a decision to start the audit of the production facilities ... and notify the applicant of its decision'.

Recorded as a separate row because it is a different authority role with a different clock, and it must not be added to paragraph 50's 30 business days — the reference-side stage and the Member-State-concerned stage run in sequence, not in parallel.

The rest of the reference-side sequence is also clocked by the Rules: audit not more than 90 business days from the decision to start it (paragraph 30); audit report within 15 business days of completion, or of the applicant's notice of nonconformity elimination (paragraph 31); expert report within 15 business days of the audit report (paragraph 32); refusal decision within 10 business days of a negative expert report (paragraph 35); placement in the information system and notice of payment within 5 business days of a positive expert report (paragraph 36); decision on registration and issue of the marketing authorisation each within 10 business days (paragraphs 40(a) and 40(b)). All of those bind the authority side, not the applicant.

The realistic range adds the applicant-side gaps between the staged clocks — the 60-business-day response window under paragraph 28 and the 30-calendar-day payment round-trip under paragraph 36 — which is why the row is in months while the published clock is in days.

Decree No. 429-Ն paragraph 19 caps the whole run from registration of the application and the required documents in the authorised body to the result at five working days for registered medical devices; paragraph 16 gives the expert organisation four working days of that for a registered device, paragraph 17 gives the authorised body one working day for the decision, and paragraph 20 allows two more working days if a paper copy of the certificate is also requested.

Paragraph 19 allows the authorised body to extend the cap by up to 10 working days for clarifications on quality and safety issues; the paragraph 14 cure time is excluded.

The clock is keyed to registration status, not to risk class, which is why this row and the next are not class rows.

The realistic range adds the applicant's own document-preparation time, which the decree does not clock.

Decree No. 429-Ն paragraph 19 caps the same run at nine working days for unregistered medical devices; paragraph 16 gives the expert organisation eight working days in that case, and paragraph 17 the same single working day for the decision.

Paragraph 19 allows the authorised body to extend the cap by up to 10 working days for clarifications on quality and safety issues.

Paragraph 14 allows the body to stop the clock for up to seven working days to let the applicant cure a defect, and paragraph 13 spends up to three working days on the initial screening of the application — neither is included in the nine-day cap.

An unregistered device must be supported by evidence of authorisation for use in the country of manufacture or in a member country of the International Medical Device Regulators Forum (Annex No. 2, paragraph 2(2)(a) of the decree).

TGA notifies the inclusion decision within 20 working days after the day the application fee was paid, the same statutory clock that applies to every class

Since October 2020 Class I applications have run through the same assessment and audit-selection process as every other class, so "notification only" no longer describes the route

In the published half-yearly snapshot, Class I applications completed without audit took a median of 1 and a mean of 3 TGA days; those selected for audit took a median of 11 and a mean of 31

The 20-working-day statutory clock runs to the inclusion decision, not to the end of an audit: if the application is selected for audit there is no legislated limit on what follows

Non-Class I applications completed without audit took a median of 9 and a mean of 10 TGA days in the published snapshot

Australia is unusual in splitting conformity assessment from market authorisation, which is what allows overseas certification to be used in place of a TGA assessment at this class

Same 20-working-day statutory inclusion clock; audit selection is more likely at this class and suspends any published limit

Level 1 compulsory audits ran to a median of 14 and a mean of 27 TGA days in the published snapshot, and Level 2 compulsory audits to a median of 161 and a mean of 174

The inclusion decision itself still carries the 20-working-day statutory clock. What makes Class III slow is what sits either side of it: an application audit, which has no legislated timeframe, and where TGA conformity assessment is required, a separate certificate that must be obtained first

Non-IVD Level 2 application audits: TGA expects the first round of specialist assessment within 100 working days, and will explain a revised timeframe if it cannot meet that

Sponsor responses to a s41JA notice or a Proposal to Refuse are due within 20-40 business days depending on complexity, and that time does not count against TGA targets

The published targets replaced an older blanket 60-working-day audit target that TGA says was arbitrary and not consistently met

Regulation 4.3 caps every Conformity Assessment application, including IVDs, at 255 working days. Within that cap TGA publishes a non-legislated target of 160 business days and a maximum of 200, aiming to meet the target in 90% of applications

These are TGA days only. TGA estimates 40-100 business days of applicant time on top, for a total of roughly 10-15 months

Segments inside the clock: pre-assessment within 30 business days, then all component areas aim to finish round 1 within 100 business days, with 20-40 business days for each applicant response round

The application clock stops while the applicant holds the file, and can be stopped by mutual agreement in extenuating circumstances — but not for holidays, missed TGA requests, or time spent translating documents or generating missing information

An on-site QMS audit report is issued within 60 days of the audit; MDSAP or EU notified-body audit evidence can substitute a desktop assessment for the on-site audit

Applies where the Advisory Committee on Medical Devices is consulted or an on-site TGA audit of manufacturing facilities is required, both of which are most common for high-risk or novel devices

Target 190 business days with TGA and a maximum of 225, plus 40-100 business days of applicant time, for roughly 12-16 months in total

Still bounded by the same 255-working-day Regulation 4.3 cap

Target 80 business days with TGA and a maximum of 150, plus 40-60 business days of applicant time, for roughly 6-10 months in total

Substantial changes to an existing certificate are not recertifications: they run on the new-or-substantial target of 160/200 business days

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

The seven-working-day clock of §7.1 is the Ministry's own decision time and applies where the submitted documents are free of deficiencies; it starts from submission of the application, or from the date the deficiency is cured where one was notified.

The Analytical Expertise Center's expertise time sits largely outside that clock (§7.12), which is why the planning range is in months while the published clock is in days.

Where deficiencies are notified, §7.3 gives the Ministry five working days from registration of the application to raise them and §7.4 gives the applicant a cure period; a certificate for a change to a registered device is issued within seven working days of the expertise opinion reaching the Ministry (§7.2, §6.12).

Same seven-working-day Ministry clock as the other registerable degrees (§7.1); the degree changes the depth of the expertise file, not the published decision period.

The registration certificate is valid for five years (§8.1), and every change to the information in the registration documents must be registered, the holder applying within seven working days (§7.8).

The dossier for a device containing a medicinal substance as a component must additionally have that substance examined before registration (§4.4).

Same seven-working-day Ministry clock (§7.1); the realistic range reflects the fuller clinical and technical file the highest degree carries through the expertise stage.

Every consignment must additionally be supported at import by the documents Article 9-1.9 of the Law on Medicinal Products requires, including the certificate of origin and the manufacturer's batch quality document.

Registration Guideline Version 9.1, general rule 11: 'The timeframe of registration application review is 20 working days.' Section 3 repeats it: 'The review process timeframe is 20 working days.'

This is the registration review clock and not the classification clock: the classification letter is a separate fee-bearing service on its own clock.

The same 20 working days is granted for all classes that must be registered (IIa, IIb and III; IVD B, C and D), so the clock is a property of the route rather than of the risk class.

An application that does not fulfil all requirements is returned with the recommended action; the applicant has two further submission attempts without repaying the application fee, and rejection on the third attempt requires the fee to be paid again.

The 2025 SLA states the same figure of 20 working days for the registration service.

Registration Guideline Version 9.1, general rule 11: 'Fast track (Through third party services) is also available with a time frame of 10 working days.'

The 2025 SLA carries the same fast-track figure. The guideline does not restrict the fast track by risk class, so the clock is a property of the route.

Classification Guideline Version 2.4, section 2: 'Timeline for reviewing the submitted documents after fees payment is 1 to 2 weeks.'

The clock runs from payment, and the guideline warns that classification is not accepted for products with different intended uses in one application (up to 10 doses or sizes), and that three failed submissions make the request a new fee-bearing request.

The letter relates to the submitted product only and does not cover other sizes or lot numbers, and it must be obtained before importation and before registration.

Registration Guideline Version 9.1, section 9 general directions: 'Timeframe of NHRA review is 20 working days.'

The applicant must inform NHRA instantly by email on receiving a change notification from the manufacturer; the variation must be approved before the amended device is imported.

A change in risk classification, in the legal or physical manufacturer or address, or in the manufacturing process is a major variation and requires a new registration application, not this clock.

This is the figure printed in the guideline currently served by NHRA. The round-204 reliance research recorded 40 working days for the variation clock with a quotation that does not appear in Version 9.1 — the string '40' does not occur anywhere in the served PDF. See unresolved.variationClock.

Citizen Charter item 24: approval of the preliminary registration ("recipe") for import of a drug, medical device or IVD reagent is 90 working days from receipt of a complete application, against a BDT 5,000 evaluation fee

DGDA publishes this clock per service, not per device class, so Class A through Class D all sit on the same 90-working-day stage

Citizen Charter item 25: grant of the import registration itself is a further 90 working days from receipt of a complete application, against a BDT 50,000 registration and analysis fee

Stages 1 and 2 run in sequence, so the charter-implied end-to-end clock for a first import registration is about 180 working days once the preliminary approval is in hand

Citizen Charter item 28: block approval to import a drug, medical device or IVD reagent from abroad is 40 working days and carries no fee

Item 30 adds a 5-working-day clock for the customs release certificate once the consignment has arrived

Citizen Charter item 26: renewal of the import registration is 60 working days from receipt of a complete application, against a BDT 10,000 renewal fee

Point 3: the complex of preliminary technical works, which is the substantive evaluation, may not exceed 90 calendar days and can be extended to at most 150 only by agreement between the applicant and the Centre for Expertise and Testing in Healthcare

The Centre is expressly forbidden to widen the scope of those works, which is what previously drove the period out to 300 days under the repealed 2008 regime

The clock is route-wide: Resolution 211 varies the dossier by risk class but not the period

Tail steps: point 10 gives the Ministry 5 working days to notify its decision, and point 12 gives 5 working days to issue the certificate once the state duty is confirmed paid

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Numeral 3.1.5 fixes 30 working days from entry of the dossier to the Dirección de Medicamentos y Tecnología en Salud for delivery of the original Registro Sanitario certificate, which is valid for five years.

This is a certificate-delivery period, not a substantive review clock: the manual fixes no separate evaluation deadline, and numerals 3.1.4(b) and (c) run before it — an observed dossier gets a written note that must be remedied within 60 calendar days, with one re-entry allowed within 60 days on payment of the second-evaluation tariff.

Numeral 2.6 requires samples only for low-risk devices; for moderate, moderate-high and high-risk devices samples are not part of the dossier, which is why the realistic range is longer for the higher classes.

Circular AGEMED N° 86/2023 numeral 4 states that, once the procedure has entered through the MISA platform, the time established for issuing Certificados de Comercialización for biomedical equipment does not exceed 5 working days.

Numeral 6: observations must be remedied within 5 working days or the file is archived without refund; numeral 12: the certificates have no specific validity until a new norm is issued.

Numeral 4.5 of the annexed directive fixes 2 months for the technical documentary analysis of an inscription once the application and the other pertinent documents are submitted.

TEXT-LAYER DISCLOSURE: the AGEMED-hosted PDF of RA 42/2024 has no digital text layer of its own. Its only extractable text is the publisher's own embedded text layer (Producer 'OmniPageCSDK19', Creator 'HP Smart Document Scan Software 3.80'), which this repository ingests as published; no OCR was run to read it. That layer systematically substitutes 'a' for 'o' — the raw text reads 'Renavacián a Rectificación de Registras Sanitarias' where the instrument says 'Renovación o Rectificación de Registros Sanitarios'. The period is unaffected by the substitution, but anyone re-verifying these figures should read the image directly. The device manual's own 30-working-day clock is a digital text layer and carries no such caveat.

The directive's scope clause (numeral 2) names 'dispositivos médicos' and 'dispositivos de diagnóstico in vitro' among the products it applies to, so a foreign regulatory decision is an admissible input for a Bolivian device registration; the periods themselves are drafted in medicines terms and AGEMED retains sovereignty over the decision.

Eligibility requires a current registration or marketing authorisation from at least one reference authority recognised by law, a PAHO/WHO listed authority being the reference set, and a sworn declaration of equivalence.

Numeral 4.5 fixes 1 month for renewal or rectification under the reliance route, half the inscription period.

Same instrument and same embedded-text-layer disclosure as the reliance-inscription row above: the period was read from the publisher's own embedded text layer, not from a digital text layer and not by OCR.

THIS ROW OVERTURNS ITS OWN EARLIER VERIFIED NEGATIVE. It previously carried no officialTimeline, on the reading that the manual fixes no period for reinscription. The manual says the opposite on its face: the Chapter III heading is 'PROCEDIMIENTOS PARA REGISTRO SANITARIO DE DISPOSITIVO MÉDICO / 3.1. PROCEDIMIENTO PARA INSCRIPCIÓN O REINSCRIPCIÓN DE DISPOSITIVOS MÉDICOS', and numeral 3.1.7 states 'El procedimiento a seguir para el caso de reinscripciones se procederá de igual manera que para la inscripción a excepción de aquellos requisitos expresamente señalados' — the exception carved out is to the requirements, not to the periods. Numeral 3.1.5's 30-working-day delivery clock, running from the date the file enters the Dirección de Medicamentos y Tecnología en Salud, therefore covers reinscription.

The IVD manual states it in terms: NORMA-2025-01 §1.6.1 is headed 'Inscripción y Reinscripción: La AGEMED, emitirá un dictamen en un plazo de 30 días hábiles a partir de la fecha de la solicitud'. The same drafting pattern appears in the medicines regulation, D.S. 25235 Art. 24 ('La reinscripción de medicamentos seguirá el mismo procedimiento de la [inscripción]').

The filing window and the late-filing tolerance are applicant-facing and are not part of the clock: numeral 3.1.7 asks for the trámite 'en lo posible dentro de los tres meses antes de la caducidad', numeral 2.3.3(a) tolerates a filing up to 30 working days after expiry as still a reinscription, and numeral 3.1.7's second paragraph makes a filing up to 30 calendar days after expiry pay the inscription tariff.

Circular AGEMED N° 63/2024 quotes the manual's numeral 2.3.3 as the reinscription requirement, but this round could not read it — it is published only as a one-page image-only scan with no text layer — so that corroboration is unconfirmed and the manual text alone carries the clock.

Čl. 65(9) of the Pravilnik gives the Agency 90 days from receipt of a complete application to issue the certificate of entry, and the period is not expressed per class, which is why the row is bound to the route.

No appeal lies against the certificate, but an administrative dispute may be brought before the competent court (čl. 65(9)).

Čl. 66(1) and (3) mean the clock only runs on a formally complete application: an incomplete request is returned for supplementation in a set period, and if it is not supplemented the Agency rejects it by conclusion (čl. 66(4)).

The exemption is limited to the class link. The class axis itself is published in the classification dataset, and the pathway differs by class in a way the clock does not.

The same čl. 65(9) clock of 90 days applies to Classes II-a, II-b and III; the Pravilnik fixes no separate period per class.

The clock covers the Agency's administrative decision only. The conformity assessment that precedes it is performed by an authorised institution or by the Commission for Medical Devices under Law čl. 101(2)(b), and neither the Law nor the Pravilnik fixes its duration.

Sterile Class I devices and Class I devices with a measuring function are assessed as Class II or III under Law čl. 101(2)(a), so they fall on this route even though their nominal class is I.

Čl. 118(1) of the Law provides that if the applicant receives no negative response from the Agency within 30 days of receipt of the notification, the clinical investigation may begin — a tacit-approval clock, not an express approval.

Čl. 118(2) requires the Agency, within 30 days of a complete notification, to give the reasons for refusal by decision, which is final in the administrative procedure with no appeal but is subject to an administrative dispute.

Čl. 118(3) stops the clock on the day the Agency requests supplementary data or explanations and restarts it only when the request is satisfied.

The clinical-investigation fee is 3,000 KM for the authorisation and 1,000 KM for the notification of a device already entered in the Register (Pravilnik 70/09 čl. 21(a) and (b)).

G01 s.4.15 publishes the screening target per route: 'Within 3 months' for the notification pathway, 'Within 1 month' for Class A and B, and 'Within 2 months' for Class C and 'Within 2 months' for Class D. The row publishes that published ladder as a range rather than picking one class.

Two query cycles are allowed. Once a query is raised the processing halts until the response is received, and if no response is received within the timeline specified in s.4.15 the application is deemed withdrawn by the applicant (G01 s.4.8(ii)).

Only after the screening step is approved does the applicant submit the evaluation application, and the s.4.15 evaluation clocks run from the accepted evaluation application with the evaluation fee paid.

G01 s.4.15 publishes the abridged target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months', with 'NA' for the notification route; the row carries the published ladder as a range.

The abridged route is the one route where a foreign approval does work: G01 Table 3 marks 'Proof of Reference Regulatory Agency' and 'Proof of Marketing Reference Regulatory Agency' as required for the abridged dossier and not required for the full dossier, which makes those two documents the eligibility evidence for entering the shorter route.

A Reference Regulatory Authority is defined in G01 s.3.1.25 as an NRA recognised by BoMRA under its policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies' — a policy this review did not retrieve, so the list of recognised authorities is not asserted here.

G01 s.4.15 publishes the full-evaluation target for local manufacturers as Class A and B 'Within 6 months', Class C 'Within 8 months' and Class D 'Within 10 months'; the row carries that published ladder as a range.

The full dossier requires, among other items, the Declaration of Conformity, the Certificate of Compliance with Recognized Standards, medical-device quality-management-system evidence, a post-market surveillance plan, an executive summary, the Summary Technical Documentation and device labelling (G01 Table 3).

Registration is site specific (G01 s.4.9) and a quality-system audit of the manufacturing site may be conducted as part of the evaluation (G01 s.4.8(v)).

G01 s.4.15 publishes the full-evaluation target for a foreign manufacturer as Class A and B 'Within 8 months', Class C 'Within 10 months' and Class D 'Within 12 months'; the row carries that ladder as a range. This is the route a foreign device manufacturer uses unless it qualifies for the abridged route.

Where the applicant is not resident in Botswana it must appoint a Local Technical Representative (also called an Authorized Representative) that is a company residing or incorporated in Botswana, and the LTR is the applicant of record (G01 s.3.1.3).

Applications for renewal must be made six months before the existing registration expires (G01 s.4.14), so a registrant has to re-enter the dossier cycle well before the five-year term ends.

G01 s.4.15 publishes the expedited target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months'. The expedited clock is the same as, or close to, the abridged clock, so expediting buys little over a supported abridged filing.

G01 does not publish the criteria for granting expedited evaluation, and no expedited fee head exists in the in-force schedule, so the route is described here only as the guideline states it.

G01 s.4.15 publishes a single 'WHO CRP — Within 3 months' row with no class columns, which is why this row carries a route-wide exemption rather than a class link. It is the shortest published route in Botswana.

The guideline adds a filing condition rather than only a clock: for WHO PQ medical devices the manufacturer has to submit a filled form 2 and form 3 along with the application (G01 s.4.8(vi)).

G01 s.4.15's periods are target assessment times; the clock stops while a query is outstanding (G01 s.4.8(ii)).

G01 s.4.15 publishes 'Major Variations — Within 3 months', 'Minor Variations — Within 3 months' and 'Notification variations — Within 1 Month'; the variation ladder is by variation type, not by device risk class, which is why the row carries a route-wide exemption.

The registered holder must inform the Authority of any significant change that could reasonably be expected to affect safety or effectiveness, and certain fundamental changes cannot be handled as a variation at all — a new dossier must be submitted (G01 s.4.13).

Notificação decided within 30 days (RDC 743/2022 Anexo)

No ANVISA review of technical merit

Unlimited validity

Notificação decided within 30 days (RDC 743/2022 Anexo)

Unlimited validity

INMETRO certification adds 3-12 months if required

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days

Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice

B-GMP certificate mandatory

10 year validity

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days

Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice

Clinical evidence mandatory

10 year validity

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Cambodia's notification states the certificate 'shall be approved within 15 business days by TRC' for an eligible application; the 15 is recorded in the registry's working-days unit, which is the basis the instrument itself uses.

The certificate is valid for two years and may be renewed 30 days before expiry; it is not transferable.

Only a firm registered in Cambodia can hold it, and only a holder can obtain a type approval or an import permit — this is the importer-side clock, not the device clock.

The notification states the type-approval certificate 'shall be approved within 15 business days'. The application route is still processed manually and the TRC states it will move the service to its online portal.

The notification records the validity as permanent — a lifetime validity for the model, recorded here as the instrument's own wording rather than as a renewal cycle.

Applies to a medical device only where the device is radiocommunication, telecommunication or ICT equipment; a device without that feature does not take this clock.

Prakas No. 499 of 8 May 2018 sets the type-approval tariff at an 80,000 riel application fee and a 4,000,000, 6,000,000 or 8,000,000 riel certificate fee by service line — a radio-equipment charge, so it is not published in the Cambodian fee dataset.

The notification states the permit 'shall generally be approved by TRC within 3 business days through the National Single Window online system', and that it is granted within 3 business days where the goods already hold a type approval and the documents are complete.

One permit covers one shipment and the permit is not transferable.

The permit is keyed to the HS headings listed in Annex 2 of Sub-Decree No. 370, which are networking, transmission, camera, drone and parts headings; a medical device is caught only where its heading is on that list.

MANDATORY CAVEAT — THIS IS A 2016 AUTHORITY-PUBLISHED SERVICE STANDARD, NOT AN ARTICLE OF THE IN-FORCE PRAKAS. The Ministry of Health's Public Service Information (2016 update) populates the 'រយៈពេលផ្តល់ជូន' (period provided) field for this service with 3-4 months and decomposes it into four one-month stages — examination of the documents and return to the company; preparation of the visa sub-committee meeting; preparation of the deciding committee meeting; and issue of the certificate once the committee has agreed. Four one-month stages are exactly the upper bound of the range. The device visa-registration procedure was re-promulgated by the Department of Drugs and Food in 2025, and that prakas is published only as a four-page image-only scan with no text layer, so it could not be read and could not be checked against this figure. If it restates, changes or drops the standard, its text governs; nothing here should be read as the statutory maximum.

This replaces the row's earlier verified negative: no retrievable Cambodian instrument states a decision period is still true of the ASEAN Medical Device Directive (Article 6 obliges a registration system and states no period) and of the National Trade Repository page for this procedure, but the Ministry's own consolidated schedule does state one, as a service standard.

The schedule's Khmer is set partly in legacy-mapped fonts, so extraction interleaves correct Unicode with substituted glyphs; everything published here rests on the Khmer and Arabic digits, which survive the substitution, and on a service identity confirmed by three independent match points against the official National Trade Repository page for the same procedure — the 400,000 riel fee, the three-year validity and the renewal at 70% of the original price. The most consequential silence in this route is that neither official description states a deadline for the applicant to return a corrected file, which is what makes the published 3-4 months unenforceable in practice.

Registration is per device; no Cambodian instrument retrieved permits grouping several devices under one registration.

The row is route-wide rather than class-specific because the schedule fixes one period for the service across classes A to D, which is why it carries a risk-class-link exemption rather than a class link.

Cambodia's own import-licensing notification, §11 item 7(a): 'No advance application is required; licenses can be applied for at any time. Licenses are often issued for landed goods. Licenses can be obtained in ten working days, if the application and supporting documents are complete. Importation may take place immediately after the issuance of a license.' Item 7(b) restates it on the legal basis of Prakas No. 093 of 9 February 2015 amending Prakas No. 1031 on Drug Import-Export Procedures, read with Joint Prakas No. 1356 of 18 November 2016: 'the timeline is ten working days'.

Item 7(d): 'The license application is considered, and the license granted by a single organ, the Department of Drugs and Food, Ministry of Health.'

This is an import licence, not a registration: it sits alongside, not in place of, the DDF device registration row above. Item 8 of the same section makes the registration the gate — a licence 'may be refused only if it fails to meet the ordinary criteria, i.e., if the drug is not registered with the Ministry of Health' — so the 3-4-month registration clock and this 10-working-day consignment clock are different gates and both belong in the dataset.

The section is headed 'PHARMACEUTICALS, MEDICAL MATERIALS AND TRADITIONAL MEDICINES' and item 4 describes the system as covering 'pharmaceuticals, medical materials, legitimate medicines and traditional medicines', so medical materials and devices imported into Cambodia take this consignment licence. The instrument says 'working days' and is recorded in the working-days unit.

Cambodia's own import-licensing notification, §13 'RADIOACTIVE CHEMICAL ELEMENTS AND ISOTOPES; NUCLEAR REACTORS, INSTALLATIONS AND APPARATUS', item V, restated at item 8: a legal entity applying for a permission letter to import and use radioactive substances and radioactive sources 'shall get the written response on the approval or the rejection of the application no later than 45 (forty-five) days from the dated of which the complete and adequate application form has been received (by the official from the OWSO)'. The instrument states 'days', not working days, and is recorded in the days unit.

This replaces the row's earlier verified negative. That negative was correct as to the document it rested on — Cambodia's national report to the Convention on Nuclear Safety describes the licensing system and the licence-holder duties and states no processing period — and this round re-read that report and confirms the silence. The country's own WTO notification supplies the period instead, and supplies it twice.

The decision clock runs on the authority; the applicant-facing items are separate. The permission letter is valid for no later than two years and permits one import only during its validity (items II and VI), and a re-application is required if nothing is imported in that period. The notification also states in terms that there is no advance-importation window and no shorter time limit for goods arriving at the port without a licence (item 6).

Reaches a medical device only where the device is an irradiating apparatus or uses radioactive sources (radiotherapy and nuclear-medicine equipment).

MDEL performance standard: 120 calendar days to issue a decision on a new, annual licence review, or reinstatement application

Class I devices carry no device licence at all — the MDEL is the only authorisation, and it licenses the establishment rather than the product

The MDEL has to be kept alive by an Annual Licence Review filed before 1 April every year, even when nothing has changed. Miss it and Health Canada cancels the licence from 1 April, after which licensable activities stop and a fresh MDEL application is the only way back

The 120-day standard has a remedy attached: if Health Canada misses it, 25% of the fee paid is credited back to the applicant

First-review service standard: 15 calendar days for the licence application (also 15 for amendments and private-label applications)

MDSAP mandatory since 2019

The standard measures first review only, from receipt of a complete application to the decision, and excludes time the applicant spends responding

First-review service standard: 60 calendar days for the licence application (near-patient IVDs included); manufacturing and significant non-manufacturing changes also 60

MDSAP mandatory

Clinical data required

First-review service standard: 75 calendar days for the licence application and Class IV changes

MDSAP mandatory

Most rigorous review

ISP ficha 9100003 v03: 60 working days on average, provided no new documents are requested; the clock is a service-charter average rather than a statutory maximum

The ficha allocates a single clock to the whole route and does not split it by risk class

Applies only to the device categories placed under sanitary control by decree, not to devices generally

ISP ficha 9100019 v08: 60 working days on average counted from the date evaluation starts, provided no new documents are requested

HIV self-test applications must be filed on paper at Av. Marathon 1000; the remaining IVD routes run through the GICONA portal

An ISP conformity-verification certificate is a documentary prerequisite for the professional-use HIV assay route

Zero days is the published position, not an estimate: the NMPA service item classifies the filing as an 即办件 and states that where the materials are complete and in the required form the filing is made 当场 — on the spot — against a sealed 备案凭证

Regulation No. 739 art. 15 completes the filing on submission of conforming materials and obliges the authority to publish the filing within 5 working days of receipt, which is a publication duty rather than a review period

Deficient materials draw a single consolidated notice of everything needing correction, so the elapsed time in practice is dossier preparation under Announcement No. 62 of 2022, which is what the realistic range measures

No fee, and no expiry; filed with the municipal authority for a domestic device and with NMPA for an imported one, through a designated Chinese legal person

Technical review 60 days under the parallel Order No. 47 Art. 92 structure; statutory administrative decision 20 working days; promised acceptance 5 working days

In-country testing required (~6 months)

Clinical often exempted

Class III technical review: 90 days for registration/change/renewal, 60 days after applicant supplement (Order No. 47 Art. 92); statutory administrative decision 20 working days; promised acceptance 5 working days

IVD technical review (Order No. 48 Art. 92): Class II IVD 60 days, Class III IVD 90 days, plus supplement clocks

Clinical trials often required

In-country testing 6-9 months

Decreto 4725/2005 Arts. 21-22 (as amended by Decreto 582/2017): once documents are complete, INVIMA issues the automatic registro administrative act within 2 working days (Classes I and IIa)

Notification-based, minimal review

Decreto 4725/2005 Arts. 21-22: automatic registro administrative act within 2 working days once documents are complete (Classes I and IIa)

Reliance pathway available for recognized approvals

Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)

Incomplete dossiers are rejected at filing (not suspended)

Technical documentation review required

Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)

Incomplete dossiers are rejected at filing (not suspended)

Clinical evidence mandatory

Class III sits outside the Decreto 3275/2009 homologation, so a reference-country approval removes nothing: all twenty numerals of the Formato Único have to be filed whatever the origin

Review 2 months for odontology devices and 4 months for microbiology and medicine devices (Gaceta 38409, art. 34.2.1)

Review 2 months for odontology devices and 4 months for microbiology and medicine devices (Gaceta 38409, art. 34.2.1)

Review 2 months for odontology devices and 4 months for microbiology and medicine devices (Gaceta 38409, art. 34.2.1)

Review 2 months for odontology devices and 4 months for microbiology and medicine devices (Gaceta 38409, art. 34.2.1)

Décision n° 000010 ARSN/DG du 6 janvier 2026, art. 18: "L'ARSN dispose d'un délai de quarante-cinq (45) jours calendaires à compter de la complétude du dossier pour accorder ou refuser une autorisation ou un agrément au demandeur." The clock runs from dossier completeness, not from deposit, and an inspection must be carried out before the grant (art. 17).

Art. 19 gives the applicant "un délai de vingt et un (21) jours calendaires pour donner suite au courrier de demande de complément de son dossier", failing which a reasoned rejection notice is sent.

Art. 6 puts radioactive sources of category 1 to 4 and generators with a tension greater than or equal to 30 kV under a licence; art. 7 puts generators strictly below 30 kV and category 5 sources under enregistrement. The ARSN website still publishes a 40 kV licence threshold on its authorisation page, which the 2026 decision supersedes; the instrument governs.

This is not an AIRP device clock and does not replace one: a device that generates or contains a radiation source still needs its AIRP Autorisation de Commercialisation or its listing declaration, and the ARSN authorisation is held by the operator using the device.

The published period is route-wide rather than class-specific: it applies to every authorisation and agrément under the decision, whatever the practice, so the row carries the route-wide exemption rather than a risk-class link.

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is EUDAMED actor and device registration plus HALMED's register entry under NN 100/2018, neither of which has a guaranteed processing time

This is the national competent-authority clock, not a conformity-assessment clock: 'Rješenje o upisu u registar distributera donosi Agencija u roku od 30 dana od dana dostave urednog zahtjeva'

The clock runs from delivery of a complete request, so it does not start while the Agency is waiting for supplements, which is why the realistic range is wider than the published period

Against the decision no appeal lies; an administrative dispute may be initiated (Article 29(2))

Article 11(3)-(4) of NN 100/2018 gives HALMED the decision where a manufacturer and a notified body disagree over the application of the classification rules; Article 11(3) sets 30 days from receipt of a complete request and Article 11(4) extends the period by 15 days where supplements are requested, so the published period is 30 to 45 days

This is a dispute-resolution clock for a national administrative act, not a route onto the market: the Union class itself remains the manufacturer's determination under MDR Annex VIII, and HALMED's own risk-classification service is a paid opinion on its price list

Art. 57: conformity assessment ends with a technical report put before the Certification Commission within 90 working days; Art. 52 puts the documentary-review notification at 10 working days from receipt

The 90 working days stop at the Commission, and neither Art. 57 nor Art. 59 puts a period on the Commission or on the direction that signs the certificate, so it is the review clock rather than a decision date

Art. 56: a notification of evaluation stops the file, and no answer within 30 working days denies it of office

Rigour rises with risk class through the procederes A to D of Regulación E 86-16, but the periods do not: A covers most Class I, B adds sterile, dental, electromedical and IVD devices and repeat suppliers, C and D cover Class IIb, III and novel devices

Art. 57 gives the renewal technical report 60 working days rather than 90

Art. 58 bases the renewal on continued conformity with the essential requirements as shown by the device in use

If no renewal application is filed by the expiry date the CECMED cancels the registration outright (E 86-16 §4.3)

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so neither the CYMDA nor a notified body reviews the file and there is no review clock

Elapsed time is EUDAMED actor and device registration, mandatory since 28 May 2026 and carrying no guaranteed processing time, plus the Cypriot notification duty under Decree No. 7, for which the CYMDA publishes no period

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

'Tiempo de respuesta: 90 días laborables' is the figure DIGEMAPS publishes for the sanitary registration of sanitary products. It is a service standard, not a statutory maximum: Ley 42-01 Art. 115 sets a 60-to-90-day limit for medicines and their registration only, and no statutory period for sanitary products was found.

The service entry is device-specific: its '¿A quién va dirigido?' is 'Empresas que se dedican a la comercialización de productos sanitarios' and its requirements list names '(Dispositivos médicos)' twice, for product plans/schematics and for product-family applications. It is the only device decision clock found in this market.

The clock is not split by product class anywhere, because there is no in-force class axis to split it by.

A related but medicines-only period is deliberately NOT recorded as a device clock: Ley 42-01 Art. 115 Párrafo IX bars the holder from marketing a product for the ninety days after a reference-laboratory-based registration, and Decreto 246-06 Art. 63 gives one month for alegaciones after a denial. Both are medicines provisions and neither is a device review clock.

The renewal service page publishes the same 90 días laborables as the registration page.

CONTRADICTION BETWEEN THE PUBLISHED FIGURE AND THE GOVERNING INSTRUMENT, disclosed rather than resolved: Decreto 117-18 as amended by Decreto 45-23 Art. 2 provides that 'La renovación de los registros sanitarios de los alimentos, medicamentos, productos sanitarios, cosméticos, higiene personal y del hogar será automática' once the renewal fee is paid and the registration to be renewed is in force, and Art. 3 provides that the automatic renewal 'se realizará a partir del depósito de la solicitud'. On the automatic-renewal reading there is no substantive review of a renewal dossier, so a 90-working-day decision clock cannot describe the ordinary case — the published 90 days describes the service counter's handling time, not a review.

The 90 días laborables stays correct for the residual case in which DIGEMAPS finds a discrepancy against an automatically renewed registration and the holder must submit a modification, which is why the row keeps its officialTimeline.

Renewal is automatic provided the renewal fee has been paid and the registration to be renewed is in force; the holder must file within the three months before expiry, and a registration that reaches expiry without an application is cancelled with no right to an extension (Decreto 117-18 as amended by Decreto 45-23, Artículos 2-4).

Where the registration has changed in any way, the modification application must be filed together with the renewal and both fees paid; if DIGEMAPS finds a discrepancy against an automatically renewed registration the holder must submit the modification procedure within 15 calendar days (Art. 2 Párrafo II), and a modification filed within the six months before expiry causes the certificate to issue with automatic renewal (Art. 5).

ARCSA publishes trámite ARCSA-004-12-01 at 1,216 working hours, shown here as 152 working days on Ecuador’s 8-hour statutory workday

The clock is route-wide: ARCSA-DE-026-2016 sets the same procedure for Class I to IV and differentiates only the dossier, not the review period

The published figure excludes the time the applicant spends answering objections

ARCSA publishes trámite ARCSA-004-01-10 at 760 working hours, shown here as 95 working days

Open to Class I to IV devices already registered by an authority that sits on the IMDRF Management Committee, capped at 100 items per application

The remaining standard-route documents are due within 30 días término of approval or ARCSA cancels the registration

The published figure is the EDA-side clock through the first requirements round, not the time to a licence: §4.1.1 gives 5 working days for the intake decision on a normal-track request and 3 for a fast-track one, and §4.1.2 gives 20 working days to review the file and send requirements on the normal track and 7 on the fast track

Nothing in the guideline puts a period on the scientific, stability or specialized registration committees that sit between the requirements round and the licence, which is why the country row is partially verified and the realistic range is an observed estimate rather than a clock

Applicant-side caps: requirements must be met within 60 working days, and a request suspended for incomplete documents is cancelled after 90 working days

The clock is route-wide — GL.CAMD.002 varies the dossier by class but publishes one set of periods for classes I through III

Non-sterile IIa, IIb and III devices with only an initial file receive a temporary acceptance number that allows importation, then 18 months to complete the registration file, with the main documents due in the first 6 months

Same caveat as the certificate route: 10 working days for the intake reply (§6.1) plus 20 working days to review the file and identify requirements (§6.2) is the published EDA clock to the first requirements round, and completions are then reviewed within 10 working days (§6.3)

The route opens with a site inspection rather than a submission: the manufacturer has 20 working days for the technical-requirements check, 120 working days to complete corrective measures and an optional 40-working-day extension before the GMP inspection report is issued

Local testing is real here — the Medical Devices Inspection Department draws samples from a pilot batch for analysis in EDA or EDA-approved laboratories, and the device must go to the specialized scientific committee and, where applicable, the stability and biocompatibility committee

A file not completed within one calendar year of acceptance is cancelled; non-sterile devices get 6 months from submission to trade after the initial evaluation

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is EUDAMED actor and device registration plus the Estonian notification and database duties, none of which has a guaranteed processing time

This is a national reporting clock, not a review clock: 'Iga ettevõtja, kes levitab Eesti turul ... IIa, IIb või III riskiklassi meditsiiniseadet või ... B-, C- või D-klassi in vitro diagnostikameditsiiniseadet, teavitab sellest Ravimiametit kümne päeva jooksul asjaomase meditsiiniseadme esmakordsest levitamisest arvates'

The same ten-day period applies to a system or procedure pack within the meaning of MDR Article 22 and to an active implantable device, so one clock spans several risk classes rather than belonging to any single one

It binds the undertaking that distributes the device, which may be an importer or distributor rather than the manufacturer, and the notification does not gate the distribution

A separate ten-day period runs in advance of placing a custom-made device on the market (MSS § 26(3)), and a ten-working-day period applies to submitting the list of in-house manufactured devices (MSS § 26(1))

Verbatim: 'Ravimiamet registreerib talle teatatud ohujuhtumi andmed ja teavitab sellest andmete esitajat kümne tööpäeva jooksul andmete esitamisest arvates'

This is the national acknowledgement of an incident report, not a market-entry clock, and it applies to every device class alike

A field safety notice for a device made available on the Estonian market must be drawn up in Estonian; the initial urgent notice may be in English (MSS § 27(2))

This is the national competent-authority clock, not a conformity-assessment clock: State Fees Act § 28⁵⁴(1) charges EUR 154 for a certificate issued within 45 days of the application, and § 28⁵⁴(3) charges EUR 308 for one issued within five working days at the applicant's request

The published clock is a service period attached to the state fee rather than a decision deadline on a market-entry application, and it applies to every device class alike

A certificate is issued only once the devices are registered in the medical devices and aids database and the data are current, so the period is not a substitute for the registration duty

Ravimiamet's own service page still cites the repealed § 29⁸² of the State Fees Act as the legal basis for the fee; the provision now in force is § 28⁵⁴

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Article 3(7) of the technical regulation: the Agency issues the registration certificate within 20 working days of submission of the application.

Article 3(8) adds 5 working days after a positive decision to enter the investigation in the register, which is public.

Article 3(9) makes registration a precondition of starting the investigation. Documents must be in Georgian or carry a notarised Georgian translation.

The same 20-working-day clock of Article 3(7) applies, but for these three classes Article 3(5) interposes a prior step the clock does not cover: the Agency registers the investigation only on the positive recommendation of the Coordination Council, which is why the planning range is longer than for class I.

Healthy volunteers may take part only in clinical investigations of non-invasive class I devices (Article 6(4)), and a clinical investigation involving medical devices may not be carried out on a foreign national (Article 6(5)).

Investigations must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020 (Article 3(2)).

Article 11^11(9): during the registration procedure the Agency decides to register or refuse within 3 months for the primary registration of a product or the registration of a Type-II variation. Article 11^11(8) counts every period from the date a complete set of registration documents is submitted.

Article 11^11(10): if the applicant is not notified of a refusal within the statutory period the product is considered registered, and the marketing-authorisation document must be issued within 10 days of the administrative act.

This clock belongs to the Law on Medicines registration route, which reaches medical goods only through the three device-type categories named in Article 11^11(19)(d) and (20)(i)-(k). General medical goods are outside it, and no equivalent statutory clock exists for them because no general device review exists.

Article 11^11(9): the Agency decides within 2 months in the case of re-registration or of the registration and recording of a product.

Article 11^11(16): circulation is permissible for 5 years after registration, and after expiry of the registration validity period until expiry of the shelf life of the batches placed on the market; Article 11^11(15) revokes the marketing-authorisation document when the validity period expires.

On re-registration the applicant files the Article 11^11(9) documents plus at least four years of side-effect data from the five-year authorisation period (Article 11^11(7)).

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Client Service Delivery Charter: fresh applications for Class I to IV devices, foreign and local alike, are processed within 6 months

The 2016 registration guideline states the same six months as a minimum rather than a ceiling, so the charter is the more favourable framing of the identical figure and the guideline is the more candid one

Neither instrument splits the clock by risk class: the four classes share one period

Client Service Delivery Charter: renewal applications for Class I to IV devices are processed within 3 months, foreign and local alike

The guideline requires the renewal to be filed at least 3 months before the existing registration expires, so the filing lead time and the processing time are the same length and only just meet

Renewals qualify for expedited evaluation under guideline §3.1.7.2.5 rather than the default first-in-first-out queue

Client Service Delivery Charter: minor variations are processed within 3 months

Post-approval variations are an expedited category under guideline §3.1.7.2.4

Client Service Delivery Charter: major variations are processed within 6 months, the same period as a fresh application

The guideline treats changes to manufacturing process, quality-control procedures, device design or intended use as the significant changes that trigger this route

Client Service Delivery Charter: new applications within 3 months and renewals within 2 months

No product is registered unless the facility complies with cGMP, so for a new manufacturing site this period runs before the registration decision rather than alongside it

Client Service Delivery Charter: new applications within 4 weeks and renewals within 3 weeks, covering medical device facilities alongside human, veterinary, herbal, cosmetic and household chemical ones

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

NUEVOS: 20 días hábiles is the MSPAS published response time on the national trámites record. NT-37 v5-2016 itself fixes no period, so this is a service standard rather than a statutory maximum.

Anexo 1 places Clase I in inscription without analysis, and trámite 3361 step 2 records that the Laboratorio Nacional de Salud analysis is not currently required for any device file, so Clase I and the higher classes run the same clock today.

Anexo 1 assigns Clases II, III and IV to inscription with physicochemical and microbiological analysis, and the norm provides that a product which fails analysis has its inscription automatically cancelled and is withdrawn within no more than 15 days.

The published 20-working-day clock covers the file as it runs today, with the analysis step recorded as not currently required; if analysis were reinstated the clock would not necessarily move, because the trámite record publishes one figure for the whole procedure.

RENOVACIONES: 15 días hábiles on trámite 3361; the same figure is published for the no-formula-change variant on trámite 3362.

The inscription is valid for five years from grant and renewal must be filed before expiry (NT-37 Arts. 8-9); if the renewal file is not filed in time the inscription lapses.

NUEVOS: 20 días hábiles on trámite 3357, whose normativa is NT-40 v3-2015. The IVD track is a separate trámite from the device track but publishes the same clocks.

NT-40 Art. 4.3 fixes the validity at five years from grant; NT-40 itself contains no review period.

RENOVACIONES: 15 días hábiles on trámite 3357; trámite 3358 publishes the same 15 working days for a renewal where the formula did not change.

GN-02 clause 5.3.1: vetting and approval should normally be completed within 12 weeks, counted from submission of the application and all required supporting information — including anything requested mid-assessment, so a question resets the practical start

Acknowledgement of receipt goes to the registered email; GN-02 clause 5.2.1 tells applicants to chase MDD only if nothing arrives within 2 weeks

Failure to supply requested supporting information within the stipulated timeframe closes the application outright rather than pausing it

Appeals against rejection, conditional-approval conditions or delisting go to the Medical Device Administration Appeal Committee within 14 working days, and the outcome is notified within 4 weeks of a complete appeal (GN-02 clauses 6.1 and 6.5)

Same 12-week GN-02 clause 5.3.1 clock as Class II and Class IV — MDD does not band the listing period by risk class

The applicant either holds an MDACS Conformity Assessment Certificate from an MDD-recognised body (D001) or submits marketing approvals from the named reference jurisdictions (D002); one or the other is mandatory

Where an MDSAP certificate is used as the QMS evidence, it must be paired with a marketing approval from a jurisdiction that itself recognises MDSAP

Same 12-week GN-02 clause 5.3.1 clock; Class IV was the first class MDACS opened to listing when the system was phased in from 2004

Approval may be conditional — commonly on annual post-market surveillance reports — and breaching a condition can lead to delisting

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): a Class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared by the manufacturer, so no authority and no notified body reviews the file and there is no review clock to publish. The regulation has the force of law in Iceland under 2. gr. laga um lækningatæki nr. 132/2020, which is why an MDR article fixes the Icelandic row.

Elapsed time to the Icelandic market is the manufacturer's own technical documentation plus EUDAMED actor and device registration, with the Icelandic-language duty for general-public instructions under reglugerð nr. 630/2022 running alongside. None of those steps has a guaranteed processing time in any Icelandic instrument — see unresolved.timeline-national-clock.

Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii))

GHTF approval provides significant advantage

Rule 20(6) chain: Notified Body audit within 90 days of application, NB report to the licensing authority within 30 days of the audit, licence decision within 20 days of the audit report (140 days total)

Licence grant-or-reject clock is 45 days where it applies (Rule 20(4))

NABL testing may be required

Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report

Clinical data required

Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report

Indian clinical trials may be required

Official service-standard clock for imported Class A izin edar (new application): 15 working days of evaluation (evaluation guideline Annex 8)

Simplified notification

Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8)

ASEAN harmonization applies

Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8)

Clinical data may be required

Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8)

Clinical evidence required

The service page states وقت إنجاز الخدمة: (10) ايام عمل كحد اقصى — ten working days maximum, which is the only numeric device clock Iraq publishes

Filing is restricted to companies, scientific offices and government bodies such as Kimadia (الشركة العامة لتسويق الادوية والمستلزمات الطبية); an individual manufacturer cannot file

The output is an evaluation of fitness for use, not a registration certificate, and the fee is set on a separate schedule linked from the service page

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

REG-2023/04: the registration certificate is sent immediately after the application is accepted in the registration system, and no later than 48 hours; non-conforming submissions receive an automatic rejection reply within 4 hours.

Eligibility: Class I (incl. Is/Im/Ir) devices and low-risk IVDs already registered and marketed in a recognized state.

REG-2024/06: new registrations handled within up to 45 working days; renewals within up to 10 working days; substantial changes up to 45 and non-substantial changes up to 10 working days.

Eligibility: Class II with an FDA 510(k)/De Novo approval and 4 months of US marketing; EU Class IIa or IVD Self Test (IVDD)/class B (IVDR) with a recognized-state approval and 4 months of marketing. Requires a lawyer-affirmed affidavit; AMAR publishes this clock by track and channel, not by risk class.

REG-2024/06: new registrations and renewals handled within up to 60 working days; substantial changes up to 60 and non-substantial changes up to 10 working days.

Eligibility: EU Class IIb or IVD LIST B (IVDD)/class C (IVDR) with approvals from two independent regulatory authorities (e.g. EU and FDA) and 6 months of marketing (with an FDA approval, actual US marketing is not required). Change applications are also open to Class III and high-risk IVDs, but the substantial-change option does not exist for Class III; AMAR publishes this clock by track and channel, not by risk class.

AMAR publishes a handling target of 120 days for regular-track new, renewal and change applications; devices not eligible for the declaration or fast tracks use this route.

AMAR publishes this target by track, not by risk class.

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

PMDA states plainly that it does not review the notification (提出された届書については審査を行いません) — it is filed on the notifier’s own responsibility, so there is no decision period to wait out

Art. 23-2-12(1) requires only that the notification be filed in advance of marketing; the product may be placed on the market from that point

No fee is payable for the notification, unlike the certification and approval routes

The manufacturer/marketer licence (製造販売業許可, third class or above) from the prefecture and the manufacturing-site registrations must already be in place before the notification is filed — those are the real lead time

Any change to a notified item must be filed within 30 days of the change date; a late filing needs a written explanation of delay to the PMDA Chief Executive

A Class I device with no matching JMDN general name, or one that is genuinely new, falls out of this route and into an approval application instead

Zero is recorded because the government sets no clock here, not because certification is instant: Enforcement Regulation Art. 129(3)(i) makes each registered certification body state its own standard processing period in the business rules it files for MHLW approval, so the period is per-body and there is no national figure to publish

MHLW notice 医薬機審発0306第1号 (6 March 2026) is what spells out that requirement for the business rules

Example of what an approved set of business rules actually commits to: SGS Japan’s 実施規程 gives up to 2 months from receipt to the start of review, review effort measured in assessor-days (1.5-5.0 for the standards-conformity assessment), and 15 business days for technical review plus issue of the certificate

This is the route for 指定高度管理医療機器等 — Class II and the designated part of Class III for which MHLW has issued a certification standard (認証基準)

The route is not elective. If a certification standard exists and the device meets it, certification is mandatory; if no standard exists or the device falls outside it, the device goes to PMDA approval instead and picks up the application-category target below

A QMS conformity investigation must be applied for to the same certification body alongside the certification application (Art. 23-2-23(3))

PMDA publishes this target by application type, not by risk class; priority-review new devices have a 9-month target

The figure comes from MHLW’s 2008 医療機器の審査迅速化アクションプログラム, and PMDA prints a caveat next to it: it is a guide to the review period, not a promise that approval will land inside it

PMDA separately commits to a mid-term-plan target of 14 months at the 80th percentile for ordinary new devices and 10 months at the 80th percentile for priority items — a longer number than the 12-month guide because it is a tile value rather than a midpoint

Observed process split (25th–median–75th percentile of total elapsed time, PMDA standard-process timeline): 1.2-1.4-1.7 months application to product briefing, 1.8-3.0-3.7 to the main round of questions, 3.7-4.8-5.3 through the answer cycles, 2.3-2.8-3.6 for expert consultation, 0.2-0.2-0.9 from review report to approval

Items that must go to the Pharmaceutical Affairs and Food Sanitation Council device committee run 11.0-12.0-12.0 months in total; items that skip committee run 3.7-7.1-10.1

Reliability and QMS investigations run in parallel with the technical review rather than after it

PMDA has reported a review lag against the United States of zero for new devices every year since FY2013; the remaining gap Japan measures is the development lag, which is when companies choose to file

PMDA publishes this target by application type, not by risk class

Mid-term-plan target is stated differently again: 10 months at the 60th percentile

Observed process split (25th–median–75th percentile): 0.2-0.8-1.6 months to product briefing, 0.5-3.1-5.7 to the main questions, 2.8-3.4-4.0 through answer cycles, 1.9-2.1-2.6 for expert consultation, 0.1-0.2-0.2 from review report to approval, for 6.5-8.4-8.8 in total

PMDA publishes this target by application type, not by risk class

Mid-term-plan target is 6 months at the 60th percentile, so the guide and the plan agree for this category

Observed process split (25th–median–75th percentile): 0.7-1.0-1.4 months to product briefing, 0.3-0.7-1.8 to the questions, 1.9-3.0-4.5 through answer cycles, 0.1-0.1-0.2 from review report to approval, for 4.9-5.8-7.3 in total

Add roughly 4 months if the item is routed through expert consultation — PMDA states that on the face of the timeline

PMDA publishes this target by application type, not by risk class

Mid-term-plan target is 4 months at the 60th percentile

Observed totals (25th–median–75th percentile): 2.6-3.9-6.0 months where a QMS investigation is required and 2.0-3.1-3.9 where it is not; since 10 July 2015 the approval application and the QMS investigation application are filed together

This is the highest-volume approval category by a wide margin, which is why the aggregate picture of Japanese review times looks faster than the new-device figures suggest

Art. 5(ي) is explicit that medical supplies in Class I and Class II a are not registered, except the items listed in Annex 7, which go to the Committee on the Annex 1 conditions

Market entry still needs the Art. 5(د) import permission, granted by the Director General on the Annexes 3 and 5 conditions; the أسس put no period on that decision, so the zero here is the absence of a registration procedure rather than a same-day approval

Art. 3(b)(3): the Committee must decide within a period not exceeding 45 working days from the date the Directorate receives the application with its documents complete

Where the device is on the list requiring laboratory testing, the same 45 working days run instead from the date the Directorate receives the analysis result from the Drug Control Laboratory, so testing time sits outside the clock

Art. 5(ب) routes these two classes to the Committee on the Annex 6 conditions

Art. 5(ح): a device that fails the laboratory test twice in a row is refused, and the applicant must start a fresh application

Art. 5(أ) pulls this group into registration whatever its class, on the Annexes 1, 4 and 5 conditions, and Art. 3(b)(3) applies the same 45-working-day committee decision to it

This is the route by which a Class I or IIa device becomes registrable in Jordan

Portal service time 70 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)

Portal service time 70 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)

Portal service time 110 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)

Portal service time 110 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)

PPB publishes its clocks by pathway, not by device class: Fig. 3 gives screening 90 days, scientific review 24 months, approval by the Board 14 days and issue of the registration certificate 7 days

Two steps inside the same chart are expressly unbounded — assessor review time carries "No timeline" and review of the applicant's response carries "No target time" — so the 24 months is the review target rather than a guaranteed decision date

The applicant's own reply is capped at not more than 6 months

Fig. 3: screening 30 days instead of 90, and the reliance review is 90 days instead of the FIFO 24 months, with the same 14-day Board approval and 7-day certificate issue

The chart publishes no review clock for the fast-track full-assessment route; this row is the reliance clock

Eligibility is set by the PPB reliance guidelines and the guidelines for fast-track review, not by risk class

Fig. 2: screening for completeness 3 days, review 30 days on the full assessment pathway or 7 days for abridged and WHO-listed products, and a final decision in 15 days

The low end of the range is the abridged and WHO-listed route (3 + 7 + 15); the high end is full assessment (3 + 30 + 15)

The CITRA service page publishes the duration in the words '20 Business days'. The dataset records it as working days, which is the same published clock on the reading that a business day is a working day; the published wording is quoted here so the mapping is visible rather than silent.

This is a CITRA equipment-type-approval clock and is NOT a Ministry of Health device-registration clock. Kuwait's Ministry of Health publishes no device-registration decision clock at all: the annex to Decree No. (387) of 2025 says only that the Standard Review Pathway 'shall undergo a full regulatory assessment in accordance with the applicable requirements, timelines, and procedures defined by' the Administration, and gives no number, and the Fast-Track and Abridged pathway sections give none either. The absence of a Ministry of Health clock is recorded in unresolved.reviewClocks.

The clock applies to equipment with a radio interface or connected to the public network, so it reaches only the radio-bearing subset of medical devices and runs alongside, not instead of, device registration.

The CITRA service page publishes the duration as '5 Business days', recorded here as working days.

The renewal fee turns on the transmitter power rather than on the device's risk class: KD 30 for each device with 10 mW output power or less and KD 50 for each device with more power.

This is a CITRA clock and not a Ministry of Health device-registration renewal clock; the Ministry publishes none, as recorded in unresolved.reviewClocks.

The CITRA service page publishes the duration as '3 Business days', recorded here as working days, and the service fee as 'Not applicable' — the permit itself carries no charge.

The permit authorizes importation in accordance with CITRA's technical rules; it is separate from the Ministry of Health customs-release approval, which the Drug and Food Control Administration describes as its own responsibility for any medical preparation arriving in Kuwait from abroad.

This is a CITRA clock and not a Ministry of Health device-registration clock.

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is EUDAMED actor and device registration plus the Latvian duties: a class I manufacturer whose place of business is registered in Latvia applies to the agency under § 28 of Cabinet Regulation No. 461 and the agency enters the information in the LATMED database within ten days under § 31

Verbatim § 11: '10 darbdienu laikā pēc šo noteikumu 9. punktā minētās informācijas saņemšanas aģentūra savā tīmekļvietnē nodrošina publisku pieejamību vismaz paziņošanas procedūras ietvaros saņemtajiem datiem par medicīnisko ierīci, tās ražotāju, pilnvaroto pārstāvi (ja attiecināms) vai paziņotāju un aģentūras piešķirto paziņojuma numuru. Pēc šīs informācijas publiskošanas aģentūras tīmekļvietnē paziņošanas procedūra uzskatāma par pabeigtu.'

The duty in § 9 falls on persons who begin to place IIa, IIb and III class devices on the Latvian market and requires the completed notification form (Annex 1) together with a copy of the EU declaration of conformity and copies of the valid notified-body certificates, so one clock spans three classes rather than belonging to any single one

The clock stops at publication, not at an approval decision, and the notification does not gate the placing of the device on the market

Verbatim § 31: 'Aģentūra izskata šo noteikumu 28. un 29. punktā minētos iesniegumus un 10 dienu laikā pēc to saņemšanas ievada attiecīgo informāciju LATMED datubāzē.'

The clock is route-wide and not class-specific: § 28 covers the manufacturers of class I devices and the assemblers of systems and procedure packs, and § 29 covers distributors, whichever class they handle

The registration is a precondition of distribution rather than of the CE route: § 41.1 provides that distributors may make devices available on the Latvian market only if the information about them as a distributor has been entered in the LATMED database, and § 41.2 extends that to manufacturers, importers and authorised representatives from 1 January 2026

The same section fixes a ten-working-day change-report clock (§ 32) and a ten-working-day discontinuation report with a seven-day agency entry (§ 34), which are not separately published here

Verbatim from ZVA's page: 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.' The agency issues the certificate in Latvian and English on the application of a manufacturer of a medical device or an in vitro diagnostic medical device, for devices manufactured in Latvia that are marked with the CE marking

The period is route-wide and class-independent, and it is published by the agency rather than in the regulation: § 23 of Cabinet Regulation No. 461 provides for the certificate and the costs but fixes no period

This is an export and free-sale certificate, not a route onto the Latvian market; the service is chargeable at EUR 185.41 under item 54 of the agency fee schedule

Verbatim § 70: 'Ārstniecības iestādes pārstāvis triju dienu laikā pēc nopietna negadījuma vai varbūtēja nopietna negadījuma ar medicīnisko ierīci nosūta aģentūrai medicīniskās ierīces lietotāja negadījuma ziņojumu (turpmāk – signālziņojums) ... un informē ražotāju vai pilnvaroto pārstāvi, vai izplatītāju'

Verbatim § 74.1: the person who uses the device, or their representative, 'triju dienu laikā informē par to aģentūru, iesniedzot signālziņojumu'

This is a national reporting clock, not a market-entry clock, and it applies to every device class alike

Official clock: the Ministry's service record for the device entry/import approval publishes the transaction period (مدة انتهاء المعاملة) as 'between one week and two weeks' and accepts applications on all official working days. The same record fixes the documents — the MPH12-26 form duly completed, an invoice giving the device name and specifications (new and unused, or renewed) and the exporting company, the Lebanese Atomic Energy Authority's approval for import or export as requested, the device specification catalogue and a letter from the party for whom the device or materials are requested — the condition that the invoice bear the Atomic Energy stamp, and the LBP 1,000 fiscal stamp.

The record states weeks rather than working days, so the range is published as 7 to 14 calendar days; it is the only published period for the general device entry route.

The clock is route-wide: the Ministerial Decision 1506/1 Art. Three levels change the documentary burden — which European-system conformity documents are accepted under Annex 1 by level — not the period, and the service record draws no distinction between devices of different levels.

Related service records publish no period at all: the sterile medical instruments import (MPH212-9) and the medical or laboratory reagents import (MPH212-3) both leave the processing-period field blank, while medical consumables for a health centre (MPH311-1) publishes 'خلال 15 يوم' — within 15 days. Only the general device entry/import record publishes a period, which is why that record is the bound clock for this row.

The 1-2 week period is the permit clock, not a promise for the whole first-entry path: before the permit the goods must satisfy the Industrial Research Institute's conformity certificate (Decision 455/1 Arts. One, Three, Four) — the Ministry's sterile-instrument record names an 'إفادة مطابقة من معهد البحوث' — and an implantable must already be registered with the Department of Programs and Projects (Decision 455/1 Art. Six), neither of which carries a published period.

The service record carries no revision date and no instrument read states the period, so it is published as the current service catalogue's own statement; the state of the Ministry's service catalogue and of the registration system after the country's recent crises is recorded in unresolved rather than assumed.

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Administrative Regulation 11/2026: Class I devices file for formality review, completed in 5 working days

Administrative Regulation 11/2026: Class IIa devices file for formality review, completed in 5 working days

Administrative Regulation 11/2026: Class IIb registration decided within 70 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply

Administrative Regulation 11/2026: Class III registration decided within 100 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply

MDA/GD/0070 cl. 6.4: Class A registration turn-around 14-20 working days from submission of complete documents and cleared payment

Simplified registration

MDA/GD/0070 cl. 6.4: Class B registration turn-around 30 working days from complete documents and cleared payment

ASEAN harmonization applies

MDA/GD/0070 cl. 6.4: Class C registration turn-around 30 working days from complete documents and cleared payment

Clinical data may be required

MDA/GD/0070 cl. 6.4: Class D registration turn-around 30 working days from complete documents and cleared payment

Clinical evidence required

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus the Maltese national registration duties in S.L. 458.59

This is the national competent-authority clock, not the conformity-assessment clock: Schedule 5 of S.L. 458.46 fixes a standard service of 30 working days from the date of submission of the application and supporting documentation, and the distributor/importer organisation registration, the certificate of free sale and the device registration lines all sit under it

Those lines carry the fast-track asterisk, so the applicant may instead buy a 10-working-day service at double the fee

The period is interrupted if the Authority requests further information or clarification and recommences on receipt of the applicant's response, which is why the realistic range is wider than the published clock

Schedule 5 places the note 'Timeline for the processing of an application is within a 90 working day timeframe' at the end of the Derogations group, in the same position as the group-level notes under the Notified Body, Clinical Investigation and Request-for-advice groups, so it governs the two EUR 1,000 initial derogation lines and the EUR 750 renewal alike

The separate 'Application for use of a Non-CE marked medical device in Malta' line (EUR 500) carries no note and falls under the 30-working-day standard service

This is the Maltese national clock for a device that has not completed conformity assessment; it is not the Annex IX notified-body clock

Schedule 5 lists the request form for medical device or in-vitro diagnostic confirmation of risk classification at EUR 1,000 under a note fixing the processing time within a 90 working day timeframe from date of submission of the application and supporting documentation

The service is optional and confirms the Union class; it is not a prerequisite for placing a device on the Maltese market and it does not replace the manufacturer's own Annex VIII classification

RIS Art. 179: Clase I resolved within 30 calendar days, with positive administrative silence (deemed approval) on lapse

LR pathway and Annex 1 low-risk registrations are faster; Annex 1 items are resolved within a maximum of 20 working days (July 2025 Acuerdo)

Registration/Equivalence realistic range remains 15-31mo in backlog periods

RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen)

ARR equivalence route (COFEPRIS-04-050, Lineamientos DOF 18-07-2025): maximum 30 working days

Equivalency route much faster if FDA approved

RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen)

ARR equivalence route (COFEPRIS-04-050): maximum 30 working days

Equivalency pathway best option with FDA

Point 6 of the procedure states that registration of a medical device that does not bear the CE marking in the State Register is carried out within up to 30 days from the moment the registration payment is made to the Agency. The clock is therefore tied to the payment, not to filing.

The 30-day period is published for this route and is not expressed per risk class, which is why the row is bound to the route rather than to a class.

The clock does not start on an incomplete dossier: point 4 allows the Agency to grant a supplementary period of up to 28 working days for the missing information, and if it is not supplied the Agency may reject the registration application.

Filing itself is preceded by a prior validation of the registration form (point 2), and the Agency may verify the truthfulness of the information and documents by requesting additional documents and consulting information sources (point 3).

Pct 20: the 10-working-day examination period runs from the date the AMDM expert takes over the dossier in the system (status 'în proces de validare'); the application counts as filed on Mpay payment confirmation (pct 19). Law 102/2017 art. 7(7) sets the same 10 working days.

Pct 33-34: remediable non-conformities put the dossier in 'suspendat' status once; the applicant has 10 working days to supply completions and the art. 7(7) period is suspended meanwhile; failure leads to rejection (pct 40.10).

Before the device dossier: cabinet access is granted or refused within 10 working days of the RSDM form (pct 8) and the manufacturer-registration application is processed within 10 working days (pct 13).

Where overlapping representative mandates are found the examination is suspended for at most 30 calendar days (pct 17).

Rejection can be challenged by a prior complaint to the Agency within 30 days under arts. 162-165 of the Administrative Code (pct 42).

Official clock: 55 working days is the sum of the published stage limits in Annex Two §§2.3 to 2.5 — initial analysis within 5 working days, expert opinion within 15 working days, tabling at the Medical Devices Council within 30 working days of the expert opinion, and issue of the certificate within 5 working days of the Council minutes. The instrument states each limit against its own triggering event and does not say the stages run back to back, so this is the sum of the limits rather than a guaranteed end-to-end period.

The applicant's own clock runs alongside: after filing through the E-business system the registrant has 5 working days to pay the registration fee (§2.2), and the procedure makes the applicant responsible for the accuracy and completeness of the submission and for paying the fee in the period demanded (§§2.4 in the listing section, 3.4).

The instrument sets no bound on when the Medical Devices Council itself meets; the 30 working days covers the working office's action to bring the matter before it.

Registration is valid for 5 years and is renewable; the renewal request and the full dossier must be filed at least 2 months before expiry, and a device whose renewal is not filed is treated as unregistered from the expiry date (§§1.3, 2.9, 2.10).

Batch-level traceability, not UDI: the device information must be entered into the electronic device database for the registration to take effect (§2.13), and Art. 11.1.7 requires the batch serial number, standard code and quantity to be entered there.

Class A (low-risk) IVDs are outside this row: Art. 33.9.1 exempts laboratory diagnostic devices other than high- and medium-risk ones from registration, so the IVD registration clock covers classes B, C and D.

Official clock: three consecutive 10-working-day stages in Annex Two section three — the working office completes the initial analysis of the listing request and sends it to the sub-council secretaries (§3.1), the request is brought to the Medical Devices Council within 10 working days of the sub-council's opinion (§3.2), and a registration number is issued and entered in the electronic system within 10 working days of the Council's decision (§3.3). 30 working days is the sum of the three published limits.

The three stages are anchored to events the instrument does not itself time — receipt of the request, the sub-council's opinion and the Council's decision — so the sum is the published stage budget, not a promise of 30 working days end to end.

Art. 33.8 requires the list entry to identify the device per country, manufacturer and model; Annex Two §3.5 gives list entries an FMD (foreign) or LMD (local) marker, the five-digit international nomenclature (GMDN) code and a five-digit list number.

ISO 13485 certification of the manufacturer's quality management system is a mandatory dossier item (§§3.9.4, 3.10.4) and the manufacturer's original letter designating the Mongolian supplying organisation is required for equipment and consumables alike (§§3.9.12, 3.10.12) — a documentary QMS requirement, not a manufacturing-site audit; whether the Agency audits foreign sites is unresolved.

No clinical investigation and no local testing are required by the procedure read; where needed, results from a national accredited laboratory or the national reference laboratory are filed instead (§§2.12.1.10, 2.12.3.5).

Official clock: within 10 working days of receiving a request to change the information of a listed device, the working office updates the electronic database by its own decision (Annex Two §3.6).

Annex Two §3.6 names only listed equipment and consumables; §2.12.3 sets no clock for amendments to a registered IVD.

The dossier for an amendment is enumerated in §2.12.3 for registered IVDs and §3.11 for listed equipment and consumables (comparative old/new labelling artwork, an explanation of the change, risk-assessment and stability reports where the change touches the valid term, and the manufacturer's old and new ISO certificates where the name or address changes).

The same 10-working-day limit covers amendments to listed equipment and consumables (§3.6) and to registered IVDs, so the row is a route-wide clock rather than one tied to a single risk grade.

Verified negative, not an estimate: Art. 33.1 makes devices registered except in the cases in Art. 33.9, and Art. 33.9.1 excludes devices other than high- and medium-risk medical equipment, medical consumables and laboratory diagnostic devices. A grade I device therefore has no application to file and the instruments fix no clock for it, which is why the row carries a published zero.

The other exempt categories are equipment spare parts and consumables needed for normal operation (33.9.2), laboratory diagnostics supplied under an agreement with an international external-quality-control body (33.9.3), orphan devices for rare diseases (33.9.4), research, training and clinical-trial devices (33.9.5), registration samples (33.9.6), exhibition devices (33.9.7), disaster and public-health-emergency devices (33.9.8), and personal-use devices received by international mail or carried by travellers (33.9.9).

The exemption is not licence to sell: Art. 33.10 prohibits the sale of devices in categories 33.9.5, 33.9.6, 33.9.7 and 33.9.9.

An import declaration is still required for each consignment of the 33.9.1 to 33.9.8 categories (Art. 44.1.4); only the personal-use category in Art. 33.9.9 is exempt from it (Art. 44.2).

This row is linked to the low-risk grade because Art. 33.9.1 is class-drawn; the situational categories in Art. 33.9.2 to 33.9.9 are not, and can cover a medium- or high-risk device (an orphan device or an emergency import, for instance) without any registration.

Čl. 40(1) gives CInMED 90 days from receipt of complete documentation to decide on the registration application; the period does not vary by risk class, which is why the row is bound to the route rather than to a class.

Čl. 40(3) allows a 30-day period to remedy an incomplete application, and čl. 40(4) suspends the 90-day clock for as long as the application is incomplete.

Čl. 41(2) gives a Class I device that is neither sterile nor has a measuring function, and an 'other' in vitro diagnostic device, a five-year registration on the manufacturer's own declaration; for every other device čl. 41(1) ties the validity to the conformity document, up to 60 days beyond its expiry.

The same čl. 40(1) clock of 90 days from complete documentation applies to Class IIa, IIb and III; the statute sets no separate period per class.

The clock is administrative only: it starts when the documentation is complete, and for these classes the conformity assessment itself is performed by a notified or appointed body under čl. 18, whose duration the Law does not fix.

Čl. 67(2) gives CInMED 30 days to decide the request; the period is not expressed per risk class, so the row is bound to the import-authorisation route.

This is a permit clock, not a registration clock: it lets an unregistered device be imported without being entered in the register.

Čl. 94(1) gives CInMED 40 days from a complete request, including the positive opinion of the ethics committee, to decide on the start of a clinical investigation.

Čl. 94(2) requires a notice of incompleteness within 10 days and gives the applicant 20 days to supplement; čl. 94(3) suspends the 40-day clock while the request is incomplete.

Čl. 101(3) requires CInMED to issue a certificate of receipt within 15 days for a post-market non-interventional study.

Čl. 42(3) gives CInMED 60 days to decide an application to amend a registration decision, and čl. 44(2) gives it 60 days to decide a renewal; neither period varies by risk class.

Čl. 41(3) adds a 90-day tail during which a device may still be placed on the market after the registration lapses, and čl. 41(4) prohibits import during that tail.

The clock is décret n° 2-14-607 art. 4, third paragraph: the Minister of Health decides within a maximum of one hundred and twenty days from the date the COMPLETE dossier is filed. The instrument sets no period for completing a dossier, so time spent answering deficiencies and producing missing items falls outside the 120 days.

This is a national dossier review, not a reliance route: the AMMPS recognition framework published in 2026 states that it covers medicines and vaccines only, so a CE, FDA, PMDA or MFDS approval does not shorten this clock — it is dossier item 4 evidence alongside the national file.

One clock is set for every risk class, so no riskLevel is recorded on this row.

The dossier is filed by the declared Moroccan establishment, not by the foreign manufacturer.

Arrêté n° 2855-15 art. 11: the administration decides on an update application within a maximum of 20 days from filing of the complete dossier, and any refusal must be justified and communicated to the establishment.

This 20-day clock is the modification clock only; the 120-day clock applies to a first registration application.

Changes bearing on the nature of the device require a new registration application instead of an update.

Article 11 of the décision expresses the period as fifteen (15) jours ouvrables; the 15-day figure is the instrument's own number and the working-day basis is recorded here because the registry's unit vocabulary is days, weeks and months only.

The clock runs from receipt of the complete application and is suspended where the ANRT issues a deficiency notice, which gives the applicant ten days to respond; it resumes from the requested supplement.

Article 7 gives the agrément a validity of ten years, and art. 15 requires the specific absorption rate to be displayed from 1 May 2025.

Applies only where the device contains radio transmitting or receiving equipment or terminal equipment attachable to a public network; a stand-alone device is not caught.

Loi n° 142-12 art. 46: the authorisations are delivered by the Agence within a period of two (2) to six (6) months running from the date of receipt of the complete dossier, and the period is fixed by regulation for each of the classes set by art. 4 of the law.

Article 45 makes the authorisation conditional on, among other things, the conformity of the radiation sources to the design and manufacturing standards required for their certification, the radioprotection qualifications of the personnel, and the safety analysis of the installation.

The authorisation attaches to the installation, the activity and their operator, so it is separate from the AMMPS device registration and is held at the site of installation and use.

The implementing decree is décret n° 2-20-131 du 25 février 2021; its class-by-class rules were not retrieved and are not asserted on this row.

NOT A REGISTRATION CLOCK — this row is deliberately separate from the registration rows. Décret n° 2-14-607 art. 14, troisième alinéa: 'Le ministre de la santé décide de l'octroi du visa de publicité après avis de la commission nationale consultative des dispositifs médicaux, et ce dans un délai maximum de soixante jours à compter de la date du dépôt du dossier complet.' It governs advertising to the public, not market access, and it must not be folded into the 120-day registration clock.

METHOD NOTE for reviewers: article 14 is invisible in the Bulletin officiel print hosted on sante.gov.ma, whose two-column layout makes text extraction truncate the article mid-way; it was recovered from the AMMPS-hosted clean text version of the same decree, where articles 4 and 14 both read cleanly. The two copies agree word for word on art. 4.

The clock runs from filing of the complete dossier, like the registration clock, and the same limitation applies: the decree fixes no period for the administration to raise a completeness objection, so the start is in practice controlled by the administration.

Two periods in the decree are internal to the administration rather than decision clocks and are not published here: art. 17 second alinéa gives the commission a second deliberation within fifteen days of a first meeting that lacked a quorum, which bounds the delay an avis can cause; art. 23 quatrième alinéa gives the inspection service seven days to transmit its report to the Minister.

Only a device holding a certificat d'enregistrement may be advertised, so this row sits behind the registration rows rather than beside them.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock.

The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates.

The DFDA Medical Device Section states an average 30-90 working-day review for imported devices. It is framed as an average rather than a service standard, and the Burmese text on the same slide drops the "working" qualifier the English carries

The clock covers step 3 of four. Step 1 is an online booking at onlineservices.fda.gov.mm to obtain an appointment date for the individual or grouping category, and step 2 is submission of both the dossier and physical product samples, so the queue for an appointment sits outside the published period

No separate clock is allocated by risk class

Companies and devices that have received an import certificate are published weekly on fda.gov.mm

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Zero regulator decision time, at every risk class. WAND is a database, not an approval: there is no pre-market assessment, no fee, and no certificate, and a completed notification is confirmed on submission once the sponsor signs the declaration under reg 7

The well-known 30 working days is a duty on the sponsor, not a review period. Reg 6 requires the device to be notified within 30 working days of becoming its sponsor, which Medsafe reads as running from the date the device first arrives in New Zealand — so supply may lawfully begin before the notification is filed

Reg 8 requires notified information to be corrected within 10 working days of it ceasing to be correct, which is also how a change of sponsor is handled: the outgoing sponsor marks entries obsolete and the incoming one re-notifies

Reg 10 forbids any statement implying that notification is an endorsement of safety or suitability, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence carrying a fine of up to $500

NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse.

Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted.

NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse.

Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted.

NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse.

Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted.

Guideline: 120 working days; RDRT-038-00 (effective 1 May 2025) standardised clocks across device classes

Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D

Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D

Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D

Чл. 131 of the Law on Medicines and Medical Devices requires the device to be entered in the register but fixes no period within which MALMED must decide the application, and no such period was found in the Law or in the 151/2010 rulebook. The clock is therefore the general administrative-procedure period.

Чл. 93 ст. 1 of the Закон за општата управна постапка provides that a first-instance procedure initiated by a party's request is completed in the shortest possible time and at the latest within 30 days of its initiation, "освен кога е поинаку предвидено со закон" (unless a law provides otherwise). Because the device law provides no other period, this residual 30-day period is the period that applies to a чл. 131 application.

Чл. 93 ст. 2 starts the period on the day the party files the request with all the evidence it was obliged to submit, so an incomplete file does not start the clock.

Чл. 94 allows the authority to extend the чл. 93 ст. 1 period once, where the complexity of the matter justifies it, for no longer than the period needed and never by more than 30 days, and requires the extension and its reason to be communicated to the party within the original period. The published row is the unextended 30-day period.

The clock is route-wide: it is fixed for the administrative procedure and does not vary by the device's risk class, which is why the row is bound to the route rather than to a class.

Same route-wide 30-day residual period as the class I row: чл. 131 fixes no decision period and чл. 93 ст. 1 of the Закон за општата управна постапка supplies the 30-day default.

Class II-а, class II-б and class III are filed on the same form (Образец бр. 2), so the submission route carries no class-specific clock.

North Macedonia is not an EU/EEA member state, so no notified-body conformity-assessment clock under MDR Annexes IX–XI applies to this row; the notified-body certificate, where there is one, is produced before the file reaches MALMED.

Same route-wide 30-day residual period as the other class rows.

A class II-б device without an EC certificate must file the risk analysis that чл. 8 of the 151/2010 rulebook requires for classes II-б and III, but that is a dossier requirement and not a separate national clock.

The register entry for a class II-б device is valid for two years under чл. 22 of the 151/2010 rulebook, which is published as registrationValidity rather than as a decision clock.

Same route-wide 30-day residual period as the other class rows.

A class III device and an active implantable medical device get a one-year register-entry validity under чл. 22 of the 151/2010 rulebook, the shortest in the schedule.

Чл. 117 of the Law sends classes II-а, II-б and III, and sterile class I devices and class I devices with a measuring function, through a conformity-assessment procedure that ends in an EC certificate of conformity issued by a notified body, and чл. 119 ст. 3 permits the EC mark to be applied. That certificate is a precondition of the file, not a MALMED clock.

Чл. 131-а ст. 4 of the Law: the Agency issues a provisional parallel-import approval "во рок од осум работни дена од денот на поднесувањето на барањето со целокупната документација и податоци од ставот 3" — within eight working days of the filing of the request with the complete documentation of ст. 3. The unit published here is working days, as the instrument states it.

Чл. 131-а ст. 5 attaches immediate effect to the provisional approval: with it the wholesaler may take part in public-procurement procedures and conclude delivery contracts for medical devices.

Чл. 131-а ст. 6: within three days of the day of full payment of the fee the Agency issues the parallel-import approval, valid for two years, which contains the data of the provisional approval and repeals it. That three-day period is a payment-triggered step inside the same route and is not published as a separate row.

Чл. 131-а ст. 7 gives the holder 60 days to notify a change to the device in the source country, and ст. 8 gives 15 days to notify a withdrawal from the market there; neither is a first-approval clock.

The parallel-import route is available for a device of any risk class, so it spans classes rather than resolving to one; the fee for it is graduated by the number of products rather than by class (чл. 3 ст. 2 of the Правилник за надоместоци).

Чл. 134 ст. 3 of the Law fixes a 30-day period after which, if the Agency has not decided, the clinical investigation is deemed approved — a tacit-approval clock rather than a decision deadline.

Чл. 134 ст. 4 and чл. 135 ст. 2 each fix a further 30-day period for the steps that follow, so the realistic end-to-end span runs to about two months.

The clock is the same for a device of any risk class and is therefore bound to the route rather than to a class.

The fee for a clinical-investigation approval or notification, and for the accompanying Ethics Committee opinion, is 240 euro each under чл. 6 of the Правилник за надоместоци.

Three separate statutory periods of 90 days, each expressed as a duty to inform the applicant of its entry in the register: чл. 123 ст. 2 "Агенцијата во рок од 90 дена го информира производителот за неговото запишување во регистарот на производители", чл. 129 ст. 1 "Агенцијата во рок од 90 дена е должна да го извести правното лице за запишувањето во регистарот на правни лица за промет на големо", and чл. 130 ст. 6 the same wording for the register of specialised retail shops.

Each of the three is qualified the same way: the period stops running on the day the Agency asks the applicant for additional documentation or data it considers necessary, and resumes on the day that request is satisfied (чл. 123 ст. 3, чл. 129 ст. 2 and чл. 130 ст. 7). The published 90 days is therefore the period on a complete file, and a request for further documentation suspends it rather than extending it by a fixed amount.

These are operator registrations, not device approvals: a foreign manufacturer's device still needs its own чл. 131 register entry, and its local representative must itself satisfy the wholesale-trade conditions or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook).

The clock does not vary with the risk class of any device, which is why the row is bound to the route rather than to a class.

The wholesale register entry carries a 471 euro fee and the specialised-retail register entry 160 euro under чл. 8 of the Правилник за надоместоци as amended.

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MoH service catalogue: 60 working days; the service page does not allocate separate clocks by risk class

Risk class drives the fee rather than the clock: OMR 100 for Class A-B and OMR 200 for Class C-D

The service will not start until the manufacturer is separately registered and the local establishment approved

MoH service catalogue: 60 working days, and this step gates the product registration rather than running alongside it

Registration lasts 5 years for a non-local manufacturer at OMR 500 and 3 years for a local manufacturer at OMR 1,500; re-registration is a separate service on the same 60-working-day clock

MoH service catalogue: 60 working days, the same clock and the same documentary conditions as an original registration

MoH service catalogue: 30 working days and no fee, available where the device activity is already active in the commercial registry and the local establishment is approved

This is the route that lets an unregistered device reach the market, so it is the practical alternative to the 60-working-day registration rather than a step within it

MoH service catalogue: 30 working days to rule whether a product is a pharmaceutical, herbal, health product, medical device or unspecialised, based on composition, form and medical claims

Borderline products need this ruling before the correct registration route can even be opened

Art. 20: applications for issue, update, renewal and correction are decided within 45 working days once the requirements are shown to be met

If the DNDM asks for additional information the applicant gets a further 45 working days, and silence is treated as withdrawal

Art. 13: the licence runs five years and renewal must be filed 60 working days before expiry

Art. 24: the DNDM answers within 30 working days of complete documentation; after a request for corrections the applicant has 60 working days and the DNDM then has a further 30 working days

Art. 21: the certificate runs five years and, for public procurement, is issued free of charge

Art. 31: Class C and D evaluations must convene two or more clinical specialists who use the device; for Class A and B that step is optional

Art. 9 first paragraph: 'Para el Proceso simplificado de Registro Sanitario, la DINAVISA contará con un plazo de cuarenta y cinco (45) días hábiles para evaluar la documentación establecida en el artículo 8° inciso a) y expedirse al respecto.'

Inconsistencies are notified; the applicant has 60 business days to rectify and a further 30 if new information raises new objections; otherwise the application is refused (Art. 9).

Art. 8's chapeau limits the routing to imported devices ('las solicitudes de inscripción de Dispositivos Médicos importados').

Eligibility rests on a prior authorisation from an authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024 Art. 3, but every published entry of that list (Resolución DINAVISA N° 182/2026) states an Alcance of medicamentos and/or vacunas, and no device-scoped entry was found — treat the route as textually available but not evidenced as operative for devices.

Art. 9 second paragraph: 'Para los productos alcanzados por el artículo 8° inciso b) de la presente Resolución, la DINAVISA contará con un plazo de ciento veinte (120) días hábiles para evaluar la documentación requerida y expedirse al respecto.'

A rectification period follows if objections are raised, and the clock is interrupted while outstanding documentation is delivered.

This is the default route for a class II-IV device that does not hold an authorisation from an authority on the Listado Anual Oficial.

Resolución DINAVISA N° 226/2024 Art. 14 fixes 45 business days for a Type II modification, the type that changes data affecting the device's identity, safety or performance.

Simple data changes are Type I modifications and do not follow this clock.

Art. 6 first paragraph: 'La DINAVISA se expedirá en un plazo de treinta (30) días hábiles respecto a la solicitud de autorización para la comercialización y uso de los productos de elaboración nacional y países incluidos en el Anexo I.'

The Annex I country list is set by the resolution itself, not by the Listado Anual Oficial used for devices.

Art. 6 second paragraph: 45 business days for products manufactured in countries not contemplated in Annex I but registered and commercialised in a country of that annex.

The applicant must add the Constancia de Registro Sanitario and the Certificado de Libre Venta in force in the Annex I country at the time of filing, over and above the Arts. 4 and 5 documents.

Art. 7 fixes 120 business days for imported IVDs from countries outside Annex I. The numeral and the period are legible; the middle of the sentence on the scanned original is obscured by the signature stamp, so the wording of the qualification is taken from the article's structure rather than quoted verbatim.

Resolución DINAVISA N° 44/2024 Art. 2: 'La DINAVISA contará con un plazo de 15 (quince) días hábiles para validar la documentación requerida y expedirse al respecto. Transcurrido el plazo y no habiendo informe alguno de la DINAVISA, la solicitud quedará aproba[da]' — approval follows by positive silence.

Objections raised during validation may be answered only once, and the route does not apply to the cases of Resolución DINAVISA N° 266/2022 Arts. 13 and 16.

DINAVISA retains in-situ inspection, suspension and cancellation powers, so the shorter clock is not a lighter substantive standard.

TUPA (D.S. 011-2026-SA): Clase I inscripción/reinscripción attended within 22 business days

Statutory calendar-day cap still in force in parallel: 30 calendar days (D.S. 016-2017-SA Art. 136)

Simplified notification process

TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)

CAN harmonization applies

TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)

Technical file review required

TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)

All device procedures carry negative administrative silence (no deemed approval on lapse)

Clinical data may be required

2025 Citizen's Charter: CMDN initial notification decided in 23 total working days for complete applications with no Notice of Deficiencies

Notification-based

2025 Citizen's Charter: CMDR Class B initial registration decided in 80 total working days for complete applications

Abridged processing (ASEAN NRA-approved Class B/C/D): 30 working days from receipt of proof of payment (FDA Circular 2022-008)

ASEAN harmonization applies

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing

Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)

Clinical data may be required

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing

Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)

Clinical evidence required

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd; RU language check 5 wd; deficit-list checks ≤5 wd

Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd

Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd

Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd

DHT/GDL/024 section 1.10.1 states that an application for registration or notification shall be processed within twenty (20) working days for the notification procedure; the registry's unit vocabulary is days, weeks and months, so the figure is recorded as 20 days and the working-day basis is recorded here.

Clock stops apply: where the Authority requests additional data, the applicant has ten (10) working days to supply it in the notification procedure, and the assessment resumes from the requested supplement.

A notification letter is valid for three (3) years, against five (5) years for a registration certificate.

Dossiers are scheduled first in, first out once the requirements are met, so elapsed time depends on the queue as well as the clock.

DHT/GDL/024 section 1.10.1 states sixty (60) working days for the abridged assessment procedure; recorded as 60 days with the working-day basis noted here because the registry's unit vocabulary is days, weeks and months.

Where additional data is requested, the applicant has twenty (20) working days to supply it and the clock stops in the meantime.

The abridged route rests on the Authority's reliance power in Article 16 of the Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics, and on the Guidelines on Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev 3), which state a 90-working-day reliance pathway for marketing authorisation excluding clock stops.

For a device assessed on the abridged route, quality-system compliance of the manufacturing site is confirmed by desk review rather than an on-site inspection, although the Authority may still inspect.

DHT/GDL/024 section 1.10.1 states one hundred eighty (180) working days for the full assessment procedure; recorded as 180 days with the working-day basis noted here because the registry's unit vocabulary is days, weeks and months.

Where additional data is requested, the applicant has sixty (60) working days to supply it and the clock stops in the meantime.

A device that holds no WHO prequalification, no SRA approval, no WHO Listed Authority registration and no EAC joint dossier assessment ordinarily runs the full procedure; a China NMPA certificate alone does not open the abridged route.

This clock is the Rwanda FDA device assessment clock. It is not the RURA type approval clock, which is a separate procedure, and it is not an import clearance clock.

SFDA publishes one lead time for every fee group in its MDMA evaluation fees table: 35 working days, from the lowest group (all Class I and general IVDs) to the highest. The FAQ repeats the same 35-business-day maximum without distinguishing risk class

There is no separate low-risk listing route any more. The Medical Device National Registry, which let non-sterile non-measuring Class A devices be listed without a technical file or an Authorized Representative, was cancelled in September 2022

What Class A still gets is a lighter dossier, not a lighter process: MDS-REQ 1 item 4 cuts the submission for low-risk devices that are not IVDs, sterile, measuring, reusable surgical instruments or novel down to six elements — device description and specification, information provided by the manufacturer, essential principles checklist, evidence of compliance, risk management file, and post-market surveillance plan and report

The abbreviated dossier is conditional: SFDA may demand the full technical documentation at any point, including after the MDMA has been granted, and it must be supplied within 10 days

SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled

Full technical file required since Jan 2022

SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled

Clinical data may be required

SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled

Extensive clinical data required

Arrêté, art. 29: « L'Agence sénégalaise de Réglementation pharmaceutique statue sur toute demande d'agrément dans un délai de trois (03) mois à compter de la réception d'un dossier complet. Lorsque le dossier est déclaré incomplet, elle notifie au demandeur, dans un délai de deux (02) jours ouvrables, les pièces manquantes. Le délai d'instruction est alors suspendu jusqu'à réception des pièces requises. »

This is the establishment agrément clock. The same arrêté sets no period for the enregistrement or marketing-authorisation phase, so no AMM clock is asserted here.

The agrément states the class or classes of device the establishment may handle (arrêté, arts. 4 and 11), but the three-month period applies whatever the class, so the clock is route-wide rather than class-specific.

Manufacturing and wholesale-import establishments need a prior inspection before the agrément is granted (arrêté, arts. 3 and 8), and the décret requires manufacturers and distributors to observe the good practices in force (art. 41).

ARSN, « Combien de temps prend le traitement d'une demande ? »: « Le délai de traitement varie selon le type d'autorisation, généralement entre 15 et 30 jours après réception d'un dossier complet. » The range is published for authorisations generally, not for a device class, so it is carried as a route-wide clock.

The same page publishes validity and the renewal window: « Une autorisation est généralement valable entre 1 et 5 ans, selon l'activité concernée » and « Le renouvellement doit être demandé au moins 30 jours avant l'expiration de l'autorisation en cours. »

The ARSN states the framework is loi n° 2021-44 du 31 décembre 2021 and defines an autorisation as written permission to carry out non-exempt activities involving ionizing radiation; the operator, not the manufacturer, holds it.

This is not an ARP device-registration clock and does not replace one: a device that generates or contains a radiation source still needs its ARP declaration or marketing authorisation separately.

Registration decided within 30 days of an accepted application (Law on Medical Devices)

Registration decided within 30 days of an accepted application (Law on Medical Devices)

Registration decided within 30 days of an accepted application (Law on Medical Devices)

Registration decided within 30 days of an accepted application (Law on Medical Devices)

Class A is exempt from product registration

Manufacturers and importers must still submit a Class A product notification in SHARE

Four Class B routes, and which one applies is decided by how many reference approvals the device already holds rather than by choice: Immediate Class B Registration is granted on submission, abridged takes 100 working days, full takes 160, and full under the Priority Review Scheme takes 104

IBR needs either one reference approval plus three years of marketing in that jurisdiction, or two reference approvals, and in both cases no global safety issue and no prior rejection or withdrawal. A standalone medical mobile application qualifies for an immediate route on one reference approval with no marketing history

Abridged needs at least one reference approval; a device with none must go full route

HSA turnaround times exclude applicant stop-clock time

Five Class C routes: an immediate route confined to standalone medical mobile applications, expedited (ECR) at 120 working days, abridged at 160, full at 220, and full under the Priority Review Scheme at 143

ECR-1 needs one reference approval plus three years of marketing there; ECR-2 needs two reference approvals. Both require no prior rejection or withdrawal by HSA or a reference agency

Hip, knee and shoulder joint replacement non-bioactive implants are barred from ECR and must go full or abridged

HSA turnaround times exclude applicant stop-clock time

Four Class D routes: expedited (EDR) at 180 working days, abridged at 220, full at 310, and full under the Priority Review Scheme at 202. There is no immediate route at Class D

EDR needs two reference approvals and no prior rejection or withdrawal. Active implantables, devices contacting the central circulatory or central nervous system, bioactive joint replacements, devices with a registrable drug in a secondary role, and HIV or donor-compatibility IVD assays are barred from EDR

A Class D device with a registrable drug in a secondary role has only abridged at 220 and full at 310, and is excluded from the Priority Review Scheme

HSA turnaround times exclude applicant stop-clock time

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

SAHPRA communication MD019 §3: establishment licence applications are processed within 6-8 weeks, and the same figure is repeated in the licensing FAQ

An expedited pathway aiming to conclude within 10-15 working days exists but is scoped to devices and IVDs required during the COVID-19 pandemic under MD005, so it is not generally available

The clock is conditional on the applicant: a deficiency observation letter must be answered within 10 working days on the standard route or 2 working days on the expedited one, only two response cycles are permitted, and a third round or a missed deadline ends the licensing process with no recommendation

One clock covers the whole route and it does not vary by device class

SAHPRA licence-renewal Q&A §3.5: processing "may be for a period of at least 4 to 8 weeks", so the lower bound is a floor rather than a promise

The renewal application must be filed at least 90 days before the licence expiry date, and licensees whose licence had already lapsed at publication were given a grace period of up to 90 days

Product-list changes can ride along with the renewal without a separate amendment as long as the licensed device class does not change; address, company-name, activity, Class D additions and responsible-person changes are amendments that carry an extra fee and can only be filed after the renewed licence has been issued

The Government24 service record puts the processing period at 즉시 — immediate, within 3 working hours — so this is a same-day filing rather than a review

It used to be a 10-day review. The Enforcement Rule amendment that took effect on 8 April 2012 converted Class I from a reviewed notification into acceptance-on-filing

Filed to the Korea Institute of Medical Device Safety Information through the e-Medis portal, not to a regional MFDS office

A Class I device that is not substantially equivalent to anything already authorised is pushed out of the notification route and into full approval (Enforcement Rule Art. 4)

Five days is the certification decision only. The technical-document review that must precede it is a separate application to a designated review body, and the K-GMP conformity assessment is separate again — those are what make the practical elapsed time months rather than a week

Korea counts a period of 5 days or less in hours from the moment of receipt, excluding Saturdays and public holidays, so this is a working-day figure

Certification is delegated to the Korea Institute of Medical Device Safety Information rather than performed by MFDS itself

Some Class II devices are carved out of certification and sent to full MFDS approval instead: combination products with a drug or quasi-drug, u-Health devices, continuously worn respiration monitors under tracking management, daily-wear hard and soft contact lenses, devices in the joint device-approval/new-health-technology process, devices that are not substantially equivalent or need clinical data, and devices whose sub-classification has not been published

Applies where no technical-document review is needed: export-only approvals whose intended use has been checked, and items proven identical to an already approved product

MFDS bands the approval clock by how much review the dossier needs, not by risk class — the same 10/65/80 ladder governs Class III and IV items and the minority of Class I and II items that are pushed into the approval route

The standard route for a Class III or IV device that does not need clinical data

A preliminary review runs first; where the attachments do not meet the requirements the applicant gets 5 days to supply what is missing

Periods of 6 days or more are counted in days from the date of receipt, excluding Saturdays and public holidays

Applies wherever clinical trial data has to be assessed, which in practice is most Class IV devices and the novel end of Class III

Same 5-day supplement window at preliminary review as the technical-document route

The clinical study itself sits outside this clock entirely

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

MepV Art. 23 applies the EU MDR conformity assessment procedures, so a Class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared with no body involved and no review clock

Swissmedic runs no product approval at all: the only Swiss step is swissdamed registration, which carries a filing deadline rather than a review period

Statutory handling period 80 calendar days (initial review 47 + post-supplement review 33) for the non-counter filing route

Legal basis: Medical Device Act and the Regulations for Issuance, Listing and Annual Declaration of Medical Device Licences

Statutory handling period 140 calendar days (initial review 75 + post-supplement review 65)

Class II in-vitro diagnostic reagents run on a separate 150-calendar-day clock (80 + 70)

Statutory handling period 200 calendar days (initial review 105 + post-supplement review 95)

Class III in-vitro diagnostic reagents run on the same 200-calendar-day clock (105 + 95)

Statutory handling period 220 calendar days (initial review 80 + post-supplement review 40 + advisory-committee review 100), covering in-vitro diagnostic medical devices as well

A world-first no-predicate device runs on a 365-calendar-day clock because the advisory review is combined with an on-site audit of the foreign manufacturer (80 + 40 + 245)

Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)

Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)

Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)

Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)

Statutory cap: class-1 notification applications decided within 200 days (Ministerial Regulation B.E. 2563 ข้อ ๕)

Practical notification processing is typically much faster than the statutory cap

Statutory cap: class-2 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)

Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file

ASEAN harmonization applies

Statutory cap: class-3 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)

Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file

Clinical data may be required

Statutory cap: class-4 registration decided within 300 days (Ministerial Regulation B.E. 2563 ข้อ ๖)

Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file

Clinical evidence required

The CERT procedure states forty-eight (48) hours from delivery of a complete dossier; it is recorded as 2 days because the registry's unit vocabulary is days, weeks and months.

This step only releases a representative unit of the equipment; it is not the homologation decision and does not by itself permit commercialisation.

The CERT procedure publishes three tiers, all counted in jours ouvrables from receipt of a complete dossier or, where applicable, from filing of the requested supplement: 3 working days for files handled at the guichet unique, 7 working days for files transferred to the centre's laboratories, and 21 working days where the Agence Nationale des Fréquences must give an opinion. The range published here spans the three tiers, in working days.

A file in dispute has a maximum processing period of three months.

The CERT also publishes a tariff of EUR 930 for applicants resident abroad, excluding customs clearance costs; it is expressed in euro and is a radio-homologation charge, so it is not published in the Tunisian fee dataset.

Applies to a medical device only where it contains radio or telecommunications terminal equipment.

Art. 52(6) of the Tıbbi Cihaz Yönetmeliği: a Class I manufacturer draws up the declaration of conformity itself once the Annex II and III technical documentation is prepared, so no body and no TİTCK review stand between the file and the market

Classes Is, Im and Ir still need a notified body, but only for sterility, the metrological function or reprocessing respectively, and no period binds that assessment

TİTCK does not run a product approval at all: the Turkish step is registration of the economic operator and the device in ÜTS, which is a filing rather than a review

The sales-centre (satış merkezi) certificate that a Turkish importer or distributor needs is a separate establishment licence, issued in 15 business days with a 45-business-day extension; it is not a device review clock

Reg. 38(1) of the National Drug Policy and Authority (Registration) Regulations, 2014 (S.I. 2014 No. 29), Part IV: 'The Authority shall determine an application for registration under these Regulations, within sixty days from the date of receipt of the application.' It is the only clock in the instrument that runs against the Authority, and reg. 38(2)-(4) name the three decisions it governs — approve and register, require further information, or refuse with reasons.

The device scope is established by reg. 2(c), which applies the Regulations to 'surgical instruments', and by Part III (regs. 24-35, Registration of Surgical Instruments), reg. 25(1) of which requires all surgical instruments to be registered by the Authority before sale or distribution. The unit is calendar days: the regulation says 'within sixty days', not working days or business days.

THE SIXTY DAYS IS NOT A WALL-CLOCK PROMISE, and the reasons are recorded rather than smoothed over. Reg. 37 lets the Authority require further information and samples in the course of examining an application without any time limit and contains no clock-stop rule; NDA's registration guideline then supplies the stop rule the statute lacks — 'Once a query or a request has been raised, the processing shall halt until after the response to the query has been received' — and adds that an application may be cancelled or rejected if no response is received 'within six months from the written query notification date'; and the licence applications that must be lodged alongside registration at NDA carry no period at all. The realistic range covers those unclocked steps around the statutory 60 days.

Registered surgical instruments are recorded in the register kept under reg. 26 in the format of Schedule 5; the certificate of registration is Form 8 under reg. 30(2) (Schedule 7), and a first registration certificate is valid for five years under reg. 40(1).

The instrument read in full is the gazetted text of S.I. 2014 No. 29 (https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf — NDA's own 'NDPA Act & Regulations' page links it under the title 'Drug Registration Regulation', the only registration regulation the Authority publishes). NDA's medical-devices page cites a later device instrument, 'statutory Instrument no 77 of the Surgical Instruments and appliances Regulation 2019', which could not be retrieved on any transport and is not listed on the Authority's own legislation page, so whether it amends or replaces this clock is unresolved and is recorded as such in the entry's other rows.

§18 of the Technical Regulation: for a Class I device that is neither custom-made nor investigational, the manufacturer follows the Annex 8 procedure and draws up the declaration of conformity, and that alone lets the device be placed on the market — no body reviews it and no period runs

CMU Resolution No. 759 of 10 June 2026 approves an MDR-aligned replacement regulation, but it is brought into effect only from 31 December 2030 (two paragraphs wait for EU accession), so Resolution 753/2013 still governs

EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class

A certificate of quality conformity or marketing authorisation — EC, 510(k) or PMA as appropriate to the class — is a required document, so a foreign approval is the price of entry rather than a shortcut

EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class

A certificate of quality conformity or marketing authorisation — EC, 510(k) or PMA as appropriate to the class — is a required document, so a foreign approval is the price of entry rather than a shortcut

EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class

Safety and efficacy data are a required document at Class III and IV

EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class

Safety and efficacy data are a required document at Class III and IV

UK MDR 2002 Part II: Class I devices that are not sterile and have no measuring function are self-declared, so no approved body or MHRA review of the file takes place and no review clock runs

Class Is and Im still need a UK approved body for the sterile barrier or the metrological function, and no statutory or published period binds that assessment

Registration with the MHRA under reg. 7A is a precondition for placing the device on the GB market, but the DORS service is self-declared and the MHRA guidance publishes no processing time

CE mark provides immediate access during transition

FDA MDUFA decision goal: 90 FDA days, excluding days on hold for an Additional Information request

The end-to-end planning range includes preparation and regulator questions

For novel devices without a legally marketed predicate

FDA review clock: 150 review days per the MDUFA decision goal, excluding time on hold (review days run between FDA receipt and decision)

FDA pages still label the goal under MDUFA IV; MDUFA V is in force for FY2026

The statutory PMA review period is 180 days after filing (21 CFR 814.40(a))

The planning range includes clinical evidence development and submission preparation

Decreto 3/008 Art. 11 sets a maximum 180-day authority clock running from filing with the Departamento de Tecnología Médica

Observations automatically suspend that clock and the applicant has 90 days to cure before the file is archived

The decree states one product-registration clock and does not allocate separate clocks by risk class

Any analysis or testing the review requires is performed at the applicant's cost in an MSP-authorised laboratory, outside the 180-day period

Decreto 3/008 Art. 11 applies the same procedures, and therefore the same 180-day maximum, to renewals

Renewal must be requested before the registration expires; Art. 13 gives 90 days to cure observations, but on a renewal the expiry of that window means the request is treated as denied rather than merely archived

Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 60 working days for Class I

Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 90 working days for Class IIa

Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III

Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III

Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file.

Decree 148/2025/NĐ-CP moved the Class A and B declaration to the provincial level, so the filing goes to the Department of Health where the business is based rather than to the Ministry

Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file.

Changes of owner, type, model, intended use or indication, and additions of a manufacturing site or product code, require the declaration to be made again rather than amended

Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days

Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval

Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted

Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice

The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning

Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day

Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days

Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval

Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted

Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice

The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning

Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day

The published clock is the IVD guideline's: 'All applications shall be evaluated within one hundred and eighty (180) working days from the date of receipt in the order of submission.' It is a queue-inclusive figure, not a pure assessment time, because it runs in order of submission.

The clock is not suspended quietly: where the Authority requests additional data the applicant must supply it within 90 working days of the request, and any extension must be requested in writing within 14 days of receipt of the request and be approved by the Authority. If the Technical Committee defers an application for unresolved safety or quality issues and the data is not provided within 90 days, the application is refused; if the applicant misses the response deadline the application is closed and must be refiled as a new application.

The realistic range adds the queue and the two-cycle query pattern to the 180 working days, which is roughly 8.3 working months of assessment on its own.

The non-IVD guideline defines 'expedited evaluation' as 'the express evaluation of a product application within a 90 - day period'. That definition is the published clock this row carries.

The Authority authorises expedited evaluation and the guideline states no criteria for granting it, so holding a WHO prequalification, an FDA approval, a CE mark or an approval in an IMDRF member state does not by itself trigger it — those are disclosure items on the Annex I form. The published commercial signal is the fee schedule's 'Fast track fees' head at double the applicable marketing authorisation fee.

The IVD guideline defines the equivalent as a 'Fast Track process' without a period of its own.

Section 1.12.2 (Time Frames — Evaluation of new applications) of the ZAMRA condom guideline: 'All applications shall be reviewed within 365 days from the date of receipt on a first come basis.' The period is queue-inclusive rather than pure assessment time, because it runs on a first-come basis; the same section separately commits the Authority to acknowledge receipt within 14 days (s.1.12.1), which also binds the Authority but is not the review clock.

The applicant-facing side of the same section is not part of the clock: 'The applicant shall be requested to provide additional data when required within 120 days of such a request. Should additional time be required, a formal request must be made and approved by the Authority.'

The instrument is a device instrument: condoms are an allied substance under the Medicines and Allied Substances Act No. 3 of 2013, and ZAMRA lists this guideline in the Medical Devices section of its guidelines page.

CAVEAT 1 — INSTRUMENT CURRENCY, stated rather than resolved: the guideline's own version table carries 'Version 1 draft March 2016', 'Version 1 released for comment April 2016' and 'Deadline for comment May 2016', then leaves both 'Version 2 published for implementation' and 'Date of implementation' blank, and the PDF's metadata Subject field reads 'DRAFT'; the file's embedded metadata gives CreationDate 6 September 2016 and ModDate 24 August 2023, and it is the version the Authority currently hosts in the Medical Devices section of its guidelines page.

CAVEAT 2 — INSTRUMENT CONFLICT, stated rather than resolved: the Authority's later general guideline, the Guidelines on Application for Grant of Marketing Authorisation of Non In-Vitro Diagnostic Medical Devices Version 2 published for implementation on 21 June 2024, governs non-IVD medical devices generally, states only that 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and fixes no period; condoms are a non-IVD device, so on one reading the 2024 general guideline governs and this 365-day clock is superseded, and on another reading the condom-specific guideline still governs because ZAMRA continues to publish it as the condom route and neither document says it replaces the other. The 365 days is published because it is a period the Authority fixed in a device instrument; the two readings are stated rather than reconciled.

The row is route-wide rather than class-specific because the condom guideline fixes one period for the product class it governs, and condoms do not sit on the A-D device axis.

The clock is RPAZ's published service standard in section 8.0 of its Client Service Charter 2026 (RPAZ/CH/LCA-02, Version 2.0, January 2026): 'Licensing of radiation devices — Import license Within 3 working days'.

It is a service-charter commitment rather than a statutory period, and the charter states that the service standard timelines are premised on the assumption that the client has met all regulatory requirements. The realistic band therefore adds the time an applicant needs to assemble a complete application and to satisfy the licence preconditions.

The import licence is route-wide: it is granted for a radiation device irrespective of any risk class, and Zimbabwe has no risk-class axis for devices to link it to.

Section 8.0 of the RPAZ Client Service Charter 2026 publishes 'License to use a radiation device — New application Within 30 days; Renewal Within 14 days'. The row carries the new-application period; renewal is the same route at 14 days.

The same charter section publishes the neighbouring clocks an importer will meet: store and possess licence 30 days new / 7 days renewal, export licence 60 days, transport permit 7 days, transit permit 1 day, design approval certificate 5 working days, registration of low-risk practices 14 days new / 7 days renewal, and exemption of materials outside regulatory control 1 day.

The licence attaches to the facility that operates the equipment — RPAZ's list of activities requiring authorisation names medical diagnostic and interventional radiology (including x-ray machines, CT scanners, mammography, fluoroscopy and Gamma Knife/Cyber Knife), radiotherapy and nuclear medicine — so the applicant is a Zimbabwean hospital, clinic or service provider, not the foreign manufacturer.

Published in section 8.0 of the RPAZ Client Service Charter 2026 as 'Design approval certificate Within 5 working days', under the heading 'Licensing of radiation devices'.

This is the closest thing Zimbabwe publishes to a product-level approval for a radiation-emitting device: it is the Authority's approval of the device design rather than a registration certificate, and it is route-wide rather than class-specific.