Review clocks by country

If a registration, amendment or cancellation application is incomplete, AKBPM invites the applicant in writing to remedy the deficiencies and submit the required data and documents within 30 days of receipt of the application; under Article 15(2) that 30 day period does not run until the applicant provides a verbal or written explanation; under Order 734 point 11 (2018) the request is refused if the documentation is not completed within the 30 days.

In all cases the review clock is suspended when additional information is requested; if the applicant establishment fails to provide the requested supplements within the time allotted, the homologation application lapses (devient caduque).

The 15 administrative working day review clock for Class I/II trámites is suspended until the applicant supplies the missing information or documentation (stop clock rule).

Statutory assessment timeframes exclude any time the TGA is waiting for the applicant to respond to a notice, letter or request for information, or to pay assessment fees; audit work cannot begin until fees are paid.

The total duration of the preliminary technical works (expertise, inspection, testing) may not exceed 90 calendar days, extendable by agreement between RUP CEIZ and the applicant to at most 150 calendar days.

Under Article 31 of the Royal Decree of 18 May 2021, within ten days of receipt of an application FAMHP informs the sponsor whether the file is complete (per MDR Annex XV chapter II); the sponsor has a maximum of ten days to comment or complete the application; FAMHP may extend that period by up to twenty days. The date on which the sponsor is informed is the validation date.

Statutory rule (Lei 6.360/1976 Art. 12 §3º, added by Lei 13.411/2016): registration must be granted within a maximum of 90 days from filing of the request, save cases of non compliance (deficiencies).

If ANVISA does not issue a conclusive manifestation by the regulatory deadline for an act whose outcome releases ANVISA from responsibility, the act is tacitly approved, except for the situations listed in the Anexo of RDC 743/2022 (e.g. initial registration of risk III materials is expressly excluded from tacit approval).

Where BDA requests missing documentation during the clinical investigation assessment, the 60 day assessment clock stops until the requested documentation is submitted.

If BDA does not decide within the 60 day assessment period, the sponsor may start the clinical investigation immediately (start on silence).

In the wholesale trade permit procedure, the 30 day decision clock stops from the date of the incompleteness notification until the deficiencies are remedied.

Class III/IV review periods (Review 1: 57 calendar days Class III, 72 days Class IV; Review 2: 42 days) exclude 3 days of administrative processing and pause while the application awaits the applicant's response to additional information letters.

Applicants have 10 days to respond to an administrative screening information request, 15 days to respond to a screening deficiency letter, and 10 or 60 days at review stage (10 days for an additional information noncompliance letter, 60 days for a deficiency letter); non response ends in rejection (screening stage, 10% of fee charged for Class III/IV) or refusal (review stage).

The MDEL performance standard is 120 calendar days from receipt of a complete application; the clock pauses when a deficiency notice is issued (restarting when the response is received) and during cost recovery holds for unpaid fees.

Under Article 7 of the Código Sanitario, the health authority must decide on an authorization/permit application within 30 working days from filing; where there are formal observations, it may — only once — grant the applicant a deadline to cure or attach documents, failing which the application is deemed withdrawn; denial must be founded.

If the health authority does not pronounce within the applicable period, the authorization is deemed granted, except for matters that by law require express authorization (which cannot start operating without it).

For high risk Class III clinical trial approval applications, CMDE must decide whether to agree within 60 days of acceptance and notify the applicant via the CMDE website; if no notice is given within the period, the trial application is deemed agreed (silence = consent).

Where supplementary information is required during review, the applicant must deliver all requested items in a single submission within 1 year of receiving the notice; failure leads to termination of the technical review or rejection of the application.

If during a service procedure the applicant fails to meet the deadlines established in the fee Reglamento without prior agreement with CECMED, CECMED considers the procedure abandoned, cancels it and notifies in writing; to pursue it again the applicant must restart it and pay the corresponding tariff anew.

The Danish Medicines Agency cannot authorise a clinical investigation (MDR Art 62(1)) or an IVD performance study (IVDR Art 66(1)) if a negative opinion from a scientific ethics committee exists; for invasive class IIa/IIb and class III devices DKMA notifies the committees and the sponsor whether the 20 day expert consultation extension of MDR Art 70(7)(b) will be used, as far as possible within 7 days of the validation date.

Under the operative 2016 norm, ARCSA performs the technical review within ten (10) working days of filing; applicant observations must be corrected within thirty (30) days, with a maximum of two rectifications of the initial application, failing which the process is cancelled. Payment of the fee order is due within ten (10) days.

Under the 2026 norm: documentary validation objections must be cured within five (5) days, once only, else the file is automatically cancelled ('solicitud no aprobada'); after a favorable review the payment order must be paid within ten (10) days; failure cancels the process. 'Término' is defined as working days.

After technical evaluation, objections must be cured within thirty (30) days for nationally manufactured products and sixty (60) days for foreign manufactured products, with a maximum of two cure rounds; failure automatically cancels the process and a new application with new fee payment is required. The ARCSA technical evaluation time itself varies by risk level, device type and complexity (no fixed total); the simplified route has a 30 day evaluation counted from filing, excluding applicant cure time.

If a registration file is suspended for missing documents, the company must complete requirements within 90 working days at most, after which the request is cancelled; the same request number is reused when completing. In the evaluation workflow the company must fulfil EDA requirements within 60 working days. Import approval and variation files follow the same 90 working day suspension rule (import files: 90 calendar days).

During assessment of a clinical investigation application, the Member State may request additional information; the expiry of the 45 day authorisation period (Art. 70(7)(b)) is suspended from the date of the first request until the additional information has been received (stop clock rule, Art. 70(6) MDR).

A clinical investigation (or IVD performance study) application and any substantial modification notification may be submitted to the EU electronic system only after the regional ethics committee has issued its opinion; Fimea's guidance states an ethics committee opinion is always required before submitting an application or notification and before starting a study.

The comité de protection des personnes (CPP) issues its opinion within 45 days from the date of validation of the file; for investigations defined at 3° of Art. R5211 1 equivalent R1125 1 (post market clinical follow up studies with additional invasive or burdensome procedures) the deadline is reduced to 30 days; CPP silence at the end of these periods equals rejection of the request.

The competent entity checks admissibility within 7 days of filing of the request and must declare a complete file valid within 3 days; the sponsor has 10 days to remedy gaps, with a possible 20 day extension.

When a query is issued to the applicant through a deferral letter, the evaluation process stops until FDA receives a written response; the evaluation may only continue if responses to all queries in the same deferral letter are contained in one submission.

If responses to queries are not submitted within 12 months from the date the queries were issued, the applicant is considered to have withdrawn the application; registration may then only be considered upon a new application.

Applications are evaluated first in first out (FIFO) unless expedited; expedited review applies to products for public health programmes (HIV/AIDS, Malaria, Tuberculosis, Reproductive Health, Neglected Tropical Diseases), paediatric programmes, Ministry of Health tender purposes, post approval variations, and renewals of registration.

For clinical trial applications, the official clock pauses upon issuance of queries and resumes on receipt of responses; applicants must address all queries within 6 months, failing which the application is treated as a new submission; failure to address outstanding issues within a year renders it null and void.

The 12 week review period commences only upon submission of the application AND all required supporting information, including supplementary information requested during assessment; failure to provide requested information within the stipulated timeframe results in closure of the application.

The authorization procedure for clinical investigations under the MDR is not governed by the general administrative procedure code (2016. évi CL. törvény, Ákr.); its deadlines follow the special national rules (33/2009 EüM rendelet) and the MDR derived timelines instead.

For Class C/D manufacture applications, where the CLA points out rectifiable deficiencies within the stipulated period, the 45 day scrutiny period under rule 21(4) runs from the date the deficiencies are removed.

Where the CLA intimates inadequate information on a no predicate (Form MD 26) application, the applicant must furnish the required information within ninety days of the intimation or the application may be rejected; the same ninety day response rule applies to new IVD (Form MD 28) applications under rule 64(2).

When additional documentation is requested, the applicant must complete it within at most 10 days of the notification for classes A, B and C, and 15 days for class D; if the deadline is missed the application expires and the PNBP fee is forfeited.

After generating the billing code, the applicant must pay the PNBP and upload the payment receipt within at most 7 days; the application is then routed to the PNBP admin for verification before evaluation.

In HPRA clinical investigation and performance study assessments, time taken by the sponsor to provide requested information is excluded from the 45 calendar day review clock; failure to respond can lead to rejection or refusal.

An application for circulation of a supply or disinfectant subject to registration and testing is not accepted until the sample passes the initial examination (الفحص الأولي); if the sample fails the initial examination it is referred to the committee, and a second failure is referred to the technical committee for rejection.

The target turn around time (TAT) for product registration applications commences from the date of receipt of the application and does not include stop clock time due to input requests. The stop clock starts whenever PPB issues an input request and ends when PPB receives a complete and satisfactory response from the applicant.

Where the medical device under application is the subject of a Field Safety Corrective Action (FSCA), the application is placed on stop clock until resolution of the FSCA.

The 20 working day registration decision term excludes the period(s) during which deficiencies established under HSL Art. 59 1(7) are being remedied.

The statutory registration decision period (70 working days Class IIb, 100 working days Class III) is suspended: (a) from the day ISAF notifies a request for additional information under Art. 10(5) until the documents are submitted; (b) from the day ISAF notifies a deficiency correction request under Art. 13(5) until correction is completed.

Regulation 5(3) MDR 2012 requires additional requested information or samples within 90 days of request; under Act 737 s. 6(5) failure to provide requested information within the specified period (or granted extension) causes the application to be deemed withdrawn, without prejudice to a new application; operationally MDA/GD/0070 applies 30 working days for mandatory information (refusal ground if missed) and 90 working days for other additional information (rejection if missed).

The Secretaría must resolve Class I device registration applications within 30 days; if it does not resolve in that period, the application is deemed granted (afirmativa ficta). Classes II and III have resolution periods of 35 and 60 days respectively (without the express positive silence sentence).

Applications to modify the conditions of a device registration (Capítulo IX insumos) must be resolved within 22 days; if the Secretaría does not resolve in that period the modification is deemed approved.

First prórroga applications must be filed 150 natural days before the registration expires; the Secretaría must resolve within a maximum of 120 natural days after filing, and if it does not resolve the prórroga is deemed granted. Second and later prórrogas are applied for every five years, at the latest 150 natural days before expiry; the acknowledgment receipt (constancia) itself has the effect of extending the registration.

The device registration processing timeline is suspended when NAFDAC issues a Compliance Directive ('the clock stops once compliances are issued'); the timeline runs to a maximum of 240 work days from acceptance of submission to issuance of the registration number.

For clinical investigation applications requiring assessment (invasive class IIa/IIb and class III devices), the 45 day assessment period is frozen for the time DMP awaits requested additional information from the sponsor; expert consultation may add 20 days.

Pending draft decree review clocks: Registro Sanitario applications attended within up to 30 working days from receipt of a complete request (Art. 66); Licencia de Operación within a maximum of 45 working days from delivery of complete documentation (Arts. 52/56); renewal decisions within 45 working days (Art. 95); IVD registrations within up to 120 working days from start of evaluation (Art. 137) and IVD renewals within 120 working days (Art. 146).

Statutory caps for evaluation of inscripción/reinscripción by risk class: Class I up to 30 calendar days; Class II up to 60 calendar days; Class III up to 90 calendar days; Class IV up to 90 calendar days (Art. 136 as replaced by D.S. 016 2017 SA). The 2026 TUPA states the operative deadlines in business days (22/44/66), which govern procedure administration.

All device registration procedures are classified as 'Evaluación previa' with negative administrative silence: if the attention deadline lapses without an answer, the applicant may pursue administrative appeals rather than enjoying automatic approval.

An Order of Payment issued by FDA is valid only for a limited window: 5 working days for CMDN initial applications, 15 working days for CMDR Class B initial applications, and 24 hours for CMDN/CMDR renewal applications; payment must be made within that window.

In clinical investigation and performance study proceedings the statutory review time limits (45 days from validation, 38 days for substantial modifications) are suspended from the day URPL requests additional information or documents until their receipt; the bioethics committee's 45 day opinion period is suspended on the same basis when it requests additional documents.

The national registration review clock excludes time for: conduct of clinical trials; response to a request for additional materials and information; response to a notification to rectify identified violations within a 30 day period.

For the Russian manufactured device route, the time from FGBU VNIIMT of Roszdravnadzor sending a query to receipt of the answer is excluded from computation of the 25 working day expertise period.

The total time for all 3 inquiry cycles of a returned MDMA application is 60 calendar days to fulfill all requirements; requests to extend beyond 60 days for valid justification must be emailed to mdma.it@sfda.gov.sa. Failure to meet the deadline results in deletion of the MDMA application.

ALIMS must register a compliant device no later than 30 days from submission; if the request is incomplete ALIMS notifies the applicant within 15 days and the applicant must complete it within 30 days of the notice; the 30 day registration deadline stops running from the day ALIMS requests additional information and resumes from submission of the requested information. Registration data are published on the ALIMS website within 7 days of the decision.

If ALIMS does not issue a renewal decision within 15 days of receiving a complete renewal request, the device may remain on the market under the previously issued registration decision; under the bylaw the last decision's validity is extended until the renewal decision but at most 90 days from its expiry, with all applicant rights and duties continuing; ALIMS must notify the Ministry's inspectorate.

Published turnaround times exclude the time taken for the applicant to respond to HSA's requests for clarification or additional information (the 'applicant's stop clock').

An applicant receiving an observation letter on deficiencies in a medical device establishment licence application is required to respond within 2 working days; overall processing timelines depend on timeous applicant responses.

AEMPS must notify the decision on operating licence applications within three months from the date the application and accompanying documentation entered its electronic register (same rule in RD 192/2023 art. 7.3 and RD 942/2025 art. 7.3).

Clinical investigation applications are evaluated in 45 calendar days from validation of the application for all device classes (per RD 192/2023), extendable by 20 calendar days for expert consultation; validation occurs within 10 calendar days (extendable by 5), deficiencies must be remedied within 10 calendar days, and the sponsor has 10 working days (extendable by 5) to answer requests; if the single binding CEIm opinion has not reached AEMPS within the 45 day period, the investigation is denied.

If deficient data or samples are requested, the applicant must submit the required information and the relevant payment within two (2) months from the date of the notification email, to the accepting point; on failure the application is given 'awaiting data' status and the evaluation report goes to the Medical Device Evaluation Committee.

In clinical investigation procedures under KlinV Mep, if the ethics committee requests additional information under Art. 10(2), the decision period is suspended until the information is received (stop clock).

When queries are raised, processing halts until the response is received; if no response to the query or request is received within 60 working days, the application is deemed withdrawn by the applicant.

The quality audit of manufacturing facilities is incorporated into the assessment process, but the published assessment timelines do not include the time for conducting site inspections.

If a detailed notification applicant fails to correct the application or supply missing information within the period set by the authority, the applicant is deemed not to wish to proceed and the authority strikes the case from the file register.

In clinical investigation review, the end of the period in the seventh paragraph (b) is frozen from the initial request date until the time the additional information is received; each period may also be extended by 5 days at the applicant's request (Madde 70(4)).

A device may not be supplied for a clinical investigation in Great Britain until the manufacturer or UK responsible person has given at least 60 days prior written notice to the Secretary of State; MHRA validates the application against a checklist, arranges a teleconference if there are possible grounds for objection, and sends a decision letter (objection or no objection) by the 60th day. There is no fee for amendments to a clinical investigation.

If additional information requested by FDA for a 510(k) is not submitted within 30 days following the date of the request, the Commissioner considers the premarket notification withdrawn (21 CFR 807.87(m)).

After FDA issues an Additional Information letter for a De Novo request, the submitter has 180 calendar days to respond, with no extensions; the request is on hold during this period and hold days are excluded from review days.

Product registrations must be authorised within a maximum of 180 days from submission of the application; if observations are issued, the period is automatically suspended and the applicants have 90 days to cure them, failing which the file is archived. (Historical note: Decreto 165/999 Art. 9 set a 40 day certificate deadline after acceptance, superseded by Decreto 3/008.)

The review deadlines exclude: the 30 working day period to cure deficiencies behind an acceptance refusal; time awaiting a foreign regulator's reply to an official authenticity request; the 60 working day period to cure deficiencies found in specialized expertise; time for conducting clinical studies; and time for the ISO 13485 production conditions inspection.