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).

From registration of the application and the required documents with the authorised body until the issue of the import (conformity) certificate or its reasoned refusal, the process may take no more than 5 working days for registered medical devices and 9 working days for unregistered medical devices, excluding the time allowed under para. 14 for curing deficiencies; where problems connected with the quality and safety of the device arise, the examination may be extended by a further 10 working days for clarifications with the manufacturer or importer (para. 19). Within that: the Expert Organisation studies and evaluates the application, the documents and their completeness within at most 3 working days including the day of registration (para. 13); the applicant is notified through the Single Window of deficiencies and has at most 7 working days to file corrected documents, that time not counting towards the total examination period (para. 14); the Expert Organisation completes the full examination within at most 4 working days for registered devices and 8 working days for unregistered ones and submits the expert conclusion (para. 16); and the authorised body grants or refuses the application within 1 working day of receiving the expert conclusion (para. 17).

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.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

Where the submitted documents are free of deficiencies, the Ministry issues the registration certificate within 7 (seven) working days of submission (or of the expertise opinion reaching the Ministry for devices under §4.4). Where curable deficiencies are found, the Ministry notifies the applicant no later than 5 (five) working days from the date the application was registered; the applicant must cure them within 10 (ten) working days, during which the clock stops. The statutory expert examination periods are excluded from the Ministry's review clock.

NHRA Registration Guideline 9.1, section 2 item 11, gives a 20 working day registration review period and a 10 working day fast track through third party services. Section 9 gives a 20 working day variation review period. Classification Guideline 2.4, Important Rules (page 3), gives one to two weeks for reviewing submitted documents after fee payment.

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.

statement: 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. · article: Numeral 4

For entry of a medical device in the Register of medical devices, the Agency issues confirmation within 90 days of receipt of a complete application. There is no appeal against the confirmation, but an administrative dispute may be initiated.

BoMRA's registration guideline publishes target timelines: screening is 3 months for the notification pathway and 1 2 months for Classes A/B, C and D; abridged assessment is 4 months (Class A and B), 6 months (Class C) and 8 months (Class D); full evaluation is 6/8/10 months for a local manufacturer and 8/10/12 months for a foreign manufacturer across Classes A/B, C and D; expedited review is 4/6/8 months; WHO CRP is 3 months; query response 1 month; exemptions 72 hours; major and minor variations 3 months; and notification variations 1 month.

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).

AITI's Table 1 states the processing time for Dealer Type Approval as 'Immediately' for Level 1 equipment and 'Seven (7) working days' for Level 2 and Level 3 equipment.

The Medicines Act contains no time limit within which the Authority must decide an application for registration or a licence; the only periods it fixes are the applicant's 14 day duty to notify changes to application information (s. 11(5)) and the 14 day appeal window (s. 21). Section 14 allows the Authority to reject a registration application without assigning any reason. No published review timeline exists for medical devices because no device application exists.

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.

Annex 1 of Joint Prakas 1356/2016 fixes, for the issuance of a visa registration certificate for medical devices, reagents, external use health support products, traditional medicines and health supplements, a maximum service delivery time of 100 working days (against 270 working days for medicines).

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.

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.

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).

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.

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.

For accepted, complete applications under the WHO prequalified IVD procedure, AIRP evaluates the product after receiving WHO information and documentation and renders its national decision within the 90 calendar day regulatory clock. Within 30 days after its decision, AIRP reports the decision to WHO and supplies the applicant with the completed report or corresponding information.

The Ministry of Health grants or refuses approval to conduct a clinical investigation of a medical device or a performance study of an IVD by a decision (rješenje) against which no appeal lies but an administrative dispute may be brought; a positive opinion of the Central Ethics Committee is an integral part of the approval procedure, and the Minister prescribes the criteria for conducting investigations by ordinance. The Act fixes no period for the Ministry's decision, so the validation and decision periods of MDR Article 70 (IVDR Article 66) govern the national handling.

The implementing act fixes two decision clocks: HALMED decides on entry in the register of distributors within 30 days of receipt of a complete request, and it must decide a classification dispute between a manufacturer and a notified body within 30 days of receipt of a complete request, extended by 15 days where it requests supplementary documentation. No statutory clock is set for the issuance of the unique registration number or of free sale certificates.

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.

A conformity assessment body established in Cyprus applies to the Notifying Authority, composed of a representative of the Coordinating Authority and of the competent authority for the product, on the form published by the Minister. The Notifying Authority examines the application and decides within 30 days whether to approve or reject it; the decision is communicated to the applicant within 10 days of being taken and, if approved, notified to the European Commission within 30 days.

Any decision imposing an administrative fine and/or recovering costs under the Law may be challenged by hierarchical appeal to the Minister within 30 days of the interested person becoming aware of it. The Minister examines the appeal immediately, may hear the appellant, and notifies the decision, which may confirm, annul or amend the fine, within 90 days of the appeal being lodged; a person dissatisfied with that decision may apply to the Administrative Court within 75 days. Unpaid fines are recovered as a civil debt to the Republic.

An interested person may lodge a hierarchical appeal to the Minister against a competent authority decision imposing measures under Articles 24 and 25 within 15 days of notification of the measure. The Minister examines the appeal immediately, may hear the appellant, and notifies the decision, which may confirm, annul or amend the contested decision, within 60 days of the appeal being lodged. A person dissatisfied with the Minister's decision may apply to the Administrative Court within 75 days.

Measures taken by the competent authority under Part IV of the Law that restrict the making available or putting into service of products must be adequately reasoned and are notified to the economic operator within 15 days of the decision, with a statement of the remedies and their deadlines. Before a measure is applied the interested party may submit its views in writing or orally within the period set in the notice, which may not be shorter than 10 working days, except where the measure is taken urgently for public health, safety or other public interest reasons, in which case the operator is heard as soon as possible and the measure is reviewed immediately.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

Renewal of sanitary registrations of productos sanitarios is automatic once the renewal fee is paid and the registration is still valid; where DIGEMAPS establishes a discrepancy or modification in the product relative to the automatically renewed registration, it notifies the user, who must submit the registration modification procedure within a non extendable period of 15 calendar days, without prejudice to statutory sanctions.

statement: DIGEMAPS publishes a response time of 90 business days for the sanitary registration of sanitary products, and the same 90 business days for renewal. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

When an application lacks the required elements, the competent organ informs the applicant so that the omissions can be cured within ten days; failing that, withdrawal is declared unless the period was reasonably extended by no more than five days at the applicant's request. DIGEMAPS' own service procedure likewise has the Dirección de Gestión de Servicios al Usuario notify missing data or documents before acceptance and allows non conforming files to be re entered after the observations are completed.

Ley 107 13 requires each procedure's regulation to set a reasonable processing period; where the governing rules provide no specific period, the supplementary period is two months and no extension may exceed one month. Periods run from the day after notification or publication and, unless stated otherwise, are counted in business days excluding Saturdays, Sundays and holidays (Párrafos I–II).

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.

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.

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.

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).

The sponsor applies to Ravimiamet to conduct a study, or to make a substantial modification to it, having regard to the requirements of the Act and of Regulation (EU) 2017/745 or (EU) 2017/746. Ravimiamet notifies its decision on the study application and on the modification notification in the procedure laid down in those Regulations; the Act contains no Estonian decision period, so the validation and decision periods of MDR Article 70 and IVDR Article 66 apply as the national handling.

Once the inspection confirms that an applicant importer, exporter or wholesaler of medicines and medical devices fulfils the requirements, the Authority issues the certificate of competence within five working days. Sub article 13 allows the Authority, in compelling circumstances and by notifying the applicant, not to issue the certificate within that period.

A regulated person who considers an administrative measure on its product or institution, or the denial of a legitimate service under the Proclamation, inappropriate, disproportionate or illegal may complain to the complaint handling organ within 30 working days of the final decision of the process owner or its confirmation by the higher official; the complaint may be brought directly if the higher official does not decide within 5 working days. The complaint handling organ must decide within 60 working days of receiving a complete complaint, and its final decision may be appealed to the court.

EFDA reviews an application for a special import (pre import) permit for medicines and medical devices, submitted through eRIS, within three working days. The application must be lodged before the consignment arrives, and the permit granted is valid for one year unless the Authority extends it.

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.

During the registration procedure the Agency must decide to register or refuse within 3 months for primary registration of a product or registration of a Type II variation, within 2 months for re registration or for registration and recording of a product, within 20 calendar days for a Type IA variation and within 40 calendar days for a Type IB variation, documented as an administrative act. The clock runs from the date of submission of a complete set of registration documents.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

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.

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.

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.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

The published response time for the medical device inscription procedure is 20 working days for new inscriptions and 15 working days for renewals.

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.

A clinical investigation of a device may be carried out only with the authorisation of Lyfjastofnun and the science ethics committee. The Act directs that the application be sent to Lyfjastofnun in accordance with Chapter VI of the Regulations and that Lyfjastofnun and the ethics committee assess it in accordance with Chapter VI; the Act itself fixes no separate Icelandic decision period, so the validation and decision periods of MDR Article 70 (and IVDR Article 66 for performance studies) govern the national handling.

Where there are reasoned grounds to suspect that a device does not meet the safety rules, Lyfjastofnun may temporarily prohibit its sale or supply while the investigation is under way. Such a temporary prohibition may not last longer than four weeks. It may be extended by up to two weeks at a time if special circumstances in the investigation require it. Where Lyfjastofnun considers a device particularly dangerous it may require the immediate withdrawal of all units of the device from the market.

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).

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.

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.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

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 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.

The agency examines the applications of Latvian established IVD manufacturers and authorised representatives (paragraph 27) and of IVD distributors (paragraph 28) and enters the information in LATMED within 10 days of receipt; a person that does not cover the agency's paragraph 18 expenses within the set period is removed from LATMED.

Within 10 working days of receiving the paragraph 8 information, the State Agency of Medicines publishes on its website at least the data received on the in vitro diagnostic device, its manufacturer, authorised representative (if applicable) or notifier and the notification number assigned by the agency; once published, the IVD notification procedure is deemed complete.

The State Agency of Medicines examines the applications of Latvian established manufacturers and authorised representatives (paragraph 28) and of distributors supplying healthcare institutions, practitioners or other distributors (paragraph 29), and enters the information in the LATMED database within 10 days of receipt. If the person does not cover the agency's annual vigilance system costs within the period set by the agency, the agency removes that person's information from LATMED.

Manufacturers with a place of business in Latvia inform the agency within 10 working days of discontinuing the placing on the market or manufacture of a device notified under paragraph 33, and of changes to the information submitted; the agency includes the submitted information in the LATMED database within seven days.

statement: Within 10 working days of receiving the paragraph 9 information, the State Agency of Medicines publishes at least the data received on the medical device, its manufacturer, authorised representative or notifier and the notification number assigned by the agency. Once that information is published on the agency's website, the notification procedure is deemed complete. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

The national procedure sets no time limit within which the health technology unit or the Minister must decide a device registration application. Where a dossier is incomplete the unit may go back to the applicant to request complements 'with indication of a deadline for the reply', fixed case by case. The procedure's conclusion lists 'délais d'examen des demandes d'enregistrement' only as an example indicator by which application of the procedure could be evaluated.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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).

Upon submission of all relevant documentation, a standard processing timeframe of 90 working days commences for an application on forms MT MDF12 and MT MDF13 for a derogation from the conformity assessment procedures. Where an extension of the derogation is required, the applicant must re apply three months before the end of the approved derogation period. A stop clock applies while the Authority awaits further information, repeating for further queries.

If, during application review, the Authority does not receive feedback from the applicant within 90 working days from the Authority's last communication, the application is automatically refused; the applicant is responsible for providing all required feedback and documentation within the specified timeframes.

A request by a Malta established applicant, manufacturer or authorised representative for the Authority's evaluation of the risk classification of a device or IVD, whether or not it arises from a dispute with a notified body over Annex VIII, is processed within 45 working days from submission of all documentation and fees. The fast track option does not apply; a stop clock runs while further information is awaited, repeating for further queries.

The standard service for processing an application under S.L. 458.46 Schedule 5 is 30 working days from submission of the application and supporting documentation. Fast track service is available for the applications marked with an asterisk in the schedule and completes within 10 working days, at double the fee. Where the Authority requires further information or clarification it communicates this to the applicant, the clock is interrupted and it recommences on receipt of the response — the Authority's own guidance describes the same stop clock restarting as further queries arise. Derogation applications and requests for advice on making available a device in Malta are on a 90 working day timeframe, and clinical investigation and performance study applications follow Union legislation and guidance timelines rather than a national clock.

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.

Under AMDM Order Rg04 264 of 8 September 2026, the 10 working day examination period begins when an AMDM expert takes the dossier in the system and its status becomes “in validation”. Where remediable deficiencies are notified, the applicant has 10 working days to provide corrections and the statutory examination period is suspended during that period.

For IVD registration the Agency's working office performs the initial analysis within 5 working days of receiving the documents, the expert produces the conclusion within 15 working days, the matter is submitted to the Medical Devices Council within 30 working days, and the certificate is issued within 5 working days of the Council minutes. For entry of equipment or consumables on the medical device list, the initial analysis and transmission to the Council secretaries is done within 10 working days, the Council decides within 10 working days, and the listing number is issued within 10 working days of the decision. A listing amendment is uploaded to the electronic database within 10 working days of receipt.

Article 8 of loi 84 12 gives the administration a maximum of ninety days from the date the establishment declaration (article 7) is filed to ask the declarant for any additional information, carry out the visit of the establishment's premises and, where applicable, notify the observations it must take into account. Once that period has passed, the administration's silence is deemed tacit acceptance.

Advertising of medical devices to health professionals entitled to prescribe or use them is subject to a prior declaration to the competent administration accompanied by the promotional material; the administration may, within thirty days from the date of receipt of the declaration, oppose the advertising if the proposed material does not comply with articles 31 and 32 (registered devices only; non misleading, objective, consistent with the registration file).

The Minister of Health decides on a registration application within a maximum of one hundred and twenty days from the date the complete dossier is filed. Any refusal of registration must be reasoned and notified to the applicant.

Article 15 of arrêté 2855 15 fixes a maximum delay from the filing of the complete file for each specific authorisation, 'sauf refus motivé': 15 days for investigational devices (valid for the duration of the clinical investigation and the number of devices needed); 3 days for a device not marketed in Morocco prescribed to a named patient (valid for one import); 15 days for used devices imported for refurbishment and export (one import export operation); 15 days for custom made devices (valid 24 months); 2 days for imported samples for evaluation with a view to registration (endorsed on the pro forma invoice, one import); and 7 days for samples for exhibition at fairs, congresses and exhibitions (one import).

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

Where the Agency does not respond negatively to a clinical investigation notification within 30 days, the applicant is deemed to be permitted to start the investigation. A change to a clinical investigation is likewise decided within 30 days.

On a parallel import application the Agency issues a temporary approval within eight working days, which allows the holder to take part in public procurement procedures and to conclude supply contracts for the device. The full approval is issued within three days of full payment of the fee and is valid for two years.

The Agency decides on entry into the register of manufacturers, of wholesale traders and of specialised retail shops and notifies the applicant within 90 days. The period is suspended from the day the Agency requests additional documentation from the applicant until that documentation is supplied, so the clock is not a pure statutory deadline.

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.

No deadline for the Medical Devices Board or DRAP to decide an enlistment or registration application was identified in the Medical Devices Rules, 2017 consolidated through April 2022. Rules 15(1) and 16(3) state that the Board considers the application and, if satisfied, enlists or registers the device. The identified time limits instead address applicant or respondent actions: renewal applications at least 60 days before expiry (rules 7(1) and 16(1)), appeals within 60 days (rule 60), show cause replies within 15 days (rules 10(2) and 20(2)), and export permit renewals three months before expiry (rule 30).

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).

After DINAVISA notifies an inconsistency or irregularity in a registration application (under either the 45 or the 120 business day evaluation track), the applicant must cure it within no more than sixty (60) business days from the first business day after notification; if the reply introduces new information that raises further inconsistencies, the second cure period is no more than thirty (30) business days; if observations are not cured in time or the technical evaluation is unsatisfactory the application is denied.

For products reached by Art. 8(b) — those not eligible for the simplified route and therefore subject to integral analysis of every Art. 6 item — DINAVISA has 120 business days to evaluate the required documentation and decide.

DINAVISA has 120 business days to decide on applications for imported IVDs from outside the countries included in Annex I.

DINAVISA decides within 30 business days on applications for national products and products of countries included in Annex I of Resolución DINAVISA N° 266/2022. It decides within 45 business days on products manufactured in countries not in Annex I but registered and commercialised in an Annex I country, which must additionally file the sanitary registration record and free sale certificate in force in an Annex I country at the time of application.

Under the IVD simplified registration process DINAVISA has 15 business days to validate the required documentation and decide; if the term elapses with no report from DINAVISA the application is approved.

For the simplified registration process DINAVISA has 45 business days to evaluate the documentation required by Art. 8(a) and decide. If the evaluation reveals an inconsistency or irregularity, the applicant is notified.

DINAVISA has forty five (45) business days to evaluate the documentation for Type II post authorisation modifications (those that must be authorised before implementation) and decide; inconsistencies are notified and must be cured within sixty (60) business days, with a further thirty (30) business days for issues arising from new information; otherwise implementation of the modification is denied.

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.

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.

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.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

Rwanda FDA commits to processing applications within 20 working days for the notification procedure, 60 working days for the abridged assessment procedure, and 180 working days for the full assessment procedure. Additional data must be submitted within 10 working days for notification, 20 working days for abridged assessment, and 60 working days for full assessment. Dossiers are scheduled for assessment on a first in first out basis. The reliance pathway for marketing authorisation under the reliance guideline is stated to take 90 working days excluding clock stops. For lower risk medical devices the registration timeline may be significantly shortened.

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.

Where the dossier is declared incomplete, the ARP notifies the applicant of the missing items within two working days; the instruction period is then suspended until the required items are received. This two working day completeness notice is the only statutory service standard on the completeness check, and it runs in the applicant's favour by starting the suspension only after notification.

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').

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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.

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.

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).

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.

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

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).

In licence and registration application review, the FDA first performs formality review (形式審查): curable defects must be completed within one month of the notice, and applications not cured in time are rejected. After formality review the FDA performs substantive review (實質審查): curable incompleteness must be completed within three months of the notice, and applications not completed in time are rejected.

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.

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.

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)).

Once NDA raises a query or a request for additional data or samples, processing of a surgical instrument/appliance application halts until the response is received. If no response is received within six months of the written query notification date, the application may be cancelled or rejected.

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.

Where no dossier amendments are requested, the Minister of Health must organise the assessment and grant the marketing number (số lưu hành) within 30 days of receiving a complete and valid dossier, including confirmation of payment of the assessment fee; where the dossier is not complete, MOH must notify the applicant of exactly which documents must be supplemented or corrected within 25 days of receiving the complete, valid dossier, and the applicant must then complete the amendments. If no number is granted, a written reasoned reply must be issued.

statement: For IVDs, all new applications shall be evaluated within 180 working days from the date of receipt in the order of submission, and the applicant shall be requested to provide additional data within 90 working days of such a request, with any extension requiring a written request within 14 days of receipt of the request, approved by the Authority. For non IVDs, an application is evaluated on a first come first served basis unless expedited evaluation has been authorised, and 'expedited evaluation' is defined as the express evaluation of a product application within a 90 day period; where a deficiency request is issued, the applicant must respond within a period specified by the Authority not exceeding 60 days, failing which the application is rejected. If unresolved safety or quality issues remain on an IVD, the Technical Committee defers recommendation and refuses approval if the applicant fails to provide the required data within 90 days.