Pure Global AI
Regulatory comparison

Medical Device Registration Timeline

Regulator review clocks and end-to-end planning ranges across 109 markets. Verified clocks link to the regulator; planning benchmarks are clearly marked.

109 markets312 pathway rows100% clocks verifiedreviewed Sep 16, 2026
Risk level
MarketClass / pathwayReview clockPlanning totalWith prior approvalProvenance
Albania flagAlbania
AKBPM
Class I(Registration with ABPM)5 working days1-3 months—Verified
Class II(Registration with ABPM)30 working days2-4 months—Verified
Class III(Registration with ABPM)30 working days3-5 months—Verified
Algeria flagAlgeria
ANPP
Medical-device homologation(ANPP registration)240-330 days9-14 months—Verified
Export-only homologation (locally manufactured)(ANPP export-only homologation)90-120 days4-7 months—Verified
Modification of a homologation decision(ANPP variation)90-120 days4-7 months—Verified
Argentina flagArgentina
ANMAT
Class I (Annex II Part A)(Sworn declaration, registered on receipt)0 working days1-3 months—Verified
Class I (all other)(Declaration of Conformity)15 working days4-6 months—Verified
Class II(Declaration of Conformity)15 working days6-12 months4-7 monthsVerified
Class III(Registration with clinical data)110 working days1-1.5 years8-12 monthsVerified
Class IV(Full Registration)110 working days1.5-2 years1-1.3 yearsVerified
Armenia flagArmenia
Ministry of Health
Class 1 and class 2a — EAEU unified registration (reference Member State route)(EAEU unified procedure under EEC Council Decision No. 46 of 12 February 2016, with Armenia as a Member State concerned; national state registration is the alternative for a device not registered in the Union)30 working days6-10 months—Verified
Class 2b and class 3 — EAEU unified registration (reference Member State route)(EAEU unified procedure under EEC Council Decision No. 46 of 12 February 2016, with Armenia as a Member State concerned; national state registration is the alternative for a device not registered in the Union)30 working days9-18 months—Verified
Any class — EAEU unified registration with Armenia acting as the reference Member State(Unified EAEU procedure under the Rules approved by EEC Council Decision No. 46 of 12 February 2016 as restated by Decision No. 144 of 24 December 2021, with Armenia's authorised authority (expert organisation) acting as the reference Member State: it draws up the expert report on the marketing-authorisation and expert-examination application and decides whether a production-facility audit is required.)45 working days6-12 months—Verified
Any class — import (conformity) certificate for a device already state-registered in Armenia(Ministry of Health import (conformity) certificate on the expert conclusion of the expert organisation, for a device with an Armenian or EAEU registration)5 working days7-15 months—Verified
Any class — import (conformity) certificate for a device without Armenian state registration(Ministry of Health import (conformity) certificate on the expert conclusion of the expert organisation, for a device that is not registered in Armenia and relies on foreign authorisation evidence)9 working days1-2.1 years—Verified
Australia flagAustralia
TGA
Class I — ARTG inclusion(Inclusion in the Australian Register of Therapeutic Goods)20 working days0.5-1 months—Verified
Class IIa — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days1-1.5 months0.8-1 monthsVerified
Class IIb — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days1.5-2 months1-1.5 monthsVerified
Class III — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days6-9 months3-5 monthsVerified
TGA Conformity Assessment certificate — new or substantial change(TGA-issued conformity assessment certification)160-200 working days10-15 months—Verified
TGA Conformity Assessment certificate — ACMD advice or on-site facility audit(TGA-issued conformity assessment certification with committee referral or on-site audit)190-225 working days1-1.3 years—Verified
TGA Conformity Assessment certificate — recertification(Recertification of an expiring TGA conformity assessment certificate)80-150 working days6-10 months—Verified
Austria flagAustria
BASG
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Azerbaijan flagAzerbaijan
Ministry of Health
Sinif 2a (medium risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry)7 working days6-12 months—Verified
Sinif 2b (high risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry)7 working days8-15 months—Verified
Sinif 3 (highest risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry)7 working days10-18 months—Verified
Bahrain flagBahrain
NHRA
Medical device registration — standard NHRA review(Application filed by a registered Bahrain Authorized Representative: the device is listed with NHRA, an appointment is booked in the Ajheza system, and the full dossier is submitted at the appointment)20 working days1-3 months—Verified
Medical device registration — fast track through third-party services(Registration application routed through a third-party service provider)10 working days1-2 months—Verified
Product classification request — NHRA classification letter(Application for a classification letter, submitted with the free sale certificate or registration certificate from the country of origin or a reference country and a recognised quality assurance certificate)1-2 weeks2-6 weeks—Verified
Minor variation review(Variation application on the NHRA variation form, filed when the change does not affect the safety or performance of the device)20 working days1-2 months—Verified
Bangladesh flagBangladesh
DGDA
All classes — stage 1, preliminary registration ("recipe") for import(DGDA preliminary registration approval)90 working days5-9 months—Verified
All classes — stage 2, grant of import registration(DGDA import registration)90 working days1-1.7 years—Verified
All classes — block import approval for a registered device(DGDA block import permission)40 working days2-4 months—Verified
All classes — renewal of import registration(DGDA registration renewal)60 working days3-6 months—Verified
Belarus flagBelarus
Ministry of Health
National registration (all classes)(Ministry of Health registration after the preliminary technical works)90-150 days5-9 months—Verified
Belgium flagBelgium
FAMHP
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Bolivia flagBolivia
AGEMED
Clases I, IIa, IIb y III — inscripción del Registro Sanitario(Dossier filed on Formulario 027 with the legal-administrative, quality-system and technical requirements of numerals 2.1 to 2.8 of the device manual; the Certificado de Registro Sanitario is delivered for five years)30 working days4-9 months—Verified
Equipos biomédicos — Certificado de Comercialización(Certificate issued on the manufacturer's or Bolivian representative's declaration (manual numeral 2.9), applied for through the MISA platform on payment of item 138 of RM 0265/2018; under manual numeral 2.9.2 it is the interim document that authorises commercialisation of biomedical equipment pending a specific equipment registration norm, one certificate per model and per institution, accessories requiring their own device Registro Sanitario (Circular 86/2023 numerals 7 and 13))5 working days1-2 months—Verified
Inscripción por reliance — decisión regulatoria de una autoridad de referencia(Registration under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024, using a current foreign registration or marketing authorisation from a reference authority as an admissible input)2 months3-6 months—Verified
Renovación o rectificación por reliance(Renewal or rectification processed under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024)1 month1-3 months—Verified
Reinscripción del Registro Sanitario a los cinco años(Reinscription following the same procedure as inscription except for the requirements expressly indicated, filed within the three months before expiry)30 working days2-6 months—Verified
Bosnia and Herzegovina flagBosnia and Herzegovina
ALMBiH
Class I — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices filed with the Agency by a manufacturer seated in BiH or by a legal person representing a foreign manufacturer and seated in BiH, with the manufacturer's own declaration of conformity (Law čl. 101(2)(a)))90 days3-7 months—Verified
Classes II-a, II-b and III — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices after conformity has been determined by an authorised institution, or by the Agency's Commission for Medical Devices where no authorised institution exists (Law čl. 101(2)(b) and the closing paragraph of čl. 101))90 days5-10 months—Verified
Clinical investigation of a medical device — tacit approval(Notification of a clinical investigation to the Agency by the manufacturer or the importer of the medical device (Law čl. 120(1)))30 days2-4 months—Verified
Botswana flagBotswana
BoMRA
Screening — all registration routes (Notification, Class A and B, Class C, Class D)(Application for screening lodged with the applicable screening fee through the BRIMS Self Service Portal; approval of the screening step is what allows the applicant to submit the evaluation application)1-3 months2-5 months—Verified
Abridged evaluation — Class B, C and D (proof of a reference regulatory agency required)(Abridged evaluation route for Class B, C and D, whose dossier must additionally carry proof of the Reference Regulatory Agency and proof of that agency's marketing authorisation)4-8 months8-14 months—Verified
Full evaluation — Class B, C and D, local manufacturer(Full evaluation route for a device manufactured in Botswana, with the complete Summary Technical Documentation dossier under G01 ss.6-8)6-10 months10-16 months—Verified
Full evaluation — Class B, C and D, foreign manufacturer(Full evaluation route for a device manufactured outside Botswana, filed through a Local Technical Representative and submitted electronically through the BRIMS Self Service Portal)8-12 months1-1.7 years—Verified
Expedited evaluation — Class B, C and D(Expedited evaluation route for Class B, C and D under G01 s.4.15)4-8 months6-12 months—Verified
WHO Collaborative Registration Procedure — all classes(Registration through the WHO Collaborative Registration Procedure, with the WHO PQ documentation submitted with the application)3 months3-8 months—Verified
Post-registration variation — major, minor and notification(Variation application to a registered device under the Medical Devices Variation Guidelines (BOMRA/ER/MED/P09/G01) referenced by G01 s.4.13, with a new dossier required where the change is fundamental)1-3 months2-5 months—Verified
Brazil flagBrazil
ANVISA
Class I(Notification)30 days1-1.5 months—Verified
Class II(Notification)30 days1-1.5 months—Verified
Class III(Registration)250-320 days1-11 months8-12 monthsVerified
Class IV(Registration)250-320 days1-11 months10-14 monthsVerified
Bulgaria flagBulgaria
BDA
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Cambodia flagCambodia
Department of Drugs and Food
TRC qualified-agent certificate — importer, supplier and distributor of radiocommunication, telecommunication and ICT equipment(Application to the Telecommunication Regulator of Cambodia through its online portal by a firm registered in Cambodia; the certificate is a precondition for a type approval and for a restricted-goods import permit (Law on Telecommunications Article 16(a); Sub-Decree No. 110 ANK/BK Article 7(a)))15 working days3-6 weeks—Verified
TRC type-approval certificate — per equipment model(Application to the TRC on the Prakas No. 208 basis, filed by a qualified agent and enclosing EMC, safety and RF test reports; the certificate is issued for each imported model and must exist before the equipment is imported (Law on Telecommunications Article 16(b); Sub-Decree No. 110 ANK/BK Article 7(b)))15 working days3-8 weeks—Verified
TRC import permit — restricted radiocommunication and ICT goods(Application through the National Single Window for goods in Annex 2 of Sub-Decree No. 370 ANK/BK of 28 December 2023, filed by a qualified agent and supported by an existing type approval for the model)3 working days1-3 weeks—Verified
Class A, B, C and D — Department of Drugs and Food medical-equipment visa registration (វិញ្ញាបនបត្រទិដ្ឋាការ បញ្ជីការ សម្ភារៈ បរិក្ខារពេទ្យ)(Dossier filed with the Department of Drugs, Food, Medical Equipment and Cosmetics through the One Window Service Office of the Ministry of Health, on the attachment list the service schedule publishes (GMP/ISO certificate, Free Sale certificate, sterility and Certificate-of-Analysis documents) and the ASEAN Common Submission Dossier Template route of AMDD Article 8(a); registration is per medical-equipment product and the certificate is valid three years)3-4 months3-8 months—Verified
Any class — Department of Drugs and Food import licence, per consignment (pharmaceuticals, medical materials and traditional medicines)(Application to the Department of Drugs and Food, Ministry of Health, at any time and with no advance application required; the licence is considered and granted by a single organ, the DDF, and importation may take place immediately after issue)10 working days2-4 weeks—Verified
MME/DONST permission letter to import radioactive substances and radioactive sources, and the underlying licence to use them(Application to the One Window Service Office of the Ministry of Mines and Energy by a public legal entity or a firm, under Prakas No. 0126 of 1 April 2021 on the Management of Import and Use of Radioactive Substances and Radioactive Sources, read with Inter-Ministerial Prakas No. 489 of 24 July 2024 on the Public Service of the Ministry of Mines and Energy; the General Department of Energy reviews the documents, evaluates on site, reports on technical safety and security, and submits to the Minister for decision)45 days2-4 months—Verified
Canada flagCanada
Health Canada
Class I(MDEL Only (no device license))4 months2-3 months—Verified
Class II(Device License)2 weeks1-1.5 months—Verified
Class III(Device License with clinical data)2 months3-4 months—Verified
Class IV(Device License)2.5 months4-5 months—Verified
Chile flagChile
ISP/ANDIM
ISP sanitary registration (medical devices)(ISP registration)60 working days3-5 months—Verified
ISP sanitary registration (in vitro diagnostics)(ISP registration)60 working days3-5 months—Verified
China flagChina
NMPA
Class I(Filing/Recordation (备案) — no review, no fee)0 days2-4 months—Verified
Class II(Provincial Registration)4 months1-1.5 years—Verified
Class III(NMPA Registration)5-6 months2-3 years1.2-1.7 yearsVerified
Colombia flagColombia
INVIMA
Class I(Notification (NSO))2 working days1-2 months—Verified
Class IIa(Registration (NSO))2 working days1-2 months2-3 monthsVerified
Class IIb(Registration (RSO))90 working days6-12 months4-6 monthsVerified
Class III(Full Registration (RSO))90 working days9-18 months—Verified
Costa Rica flagCosta Rica
Ministry of Health
Class 1(MINSA registration)2-4 months3-6 months—Verified
Class 2(MINSA registration)2-4 months3-6 months—Verified
Class 3(MINSA registration)2-4 months4-7 months—Verified
Class 4(MINSA registration)2-4 months5-8 months—Verified
Côte d'Ivoire flagCôte d'Ivoire
AIRP
ARSN authorisation, licence, enregistrement or agrément — a device or installation using ionizing radiation(Autorisation or agrément issued by the ARSN under loi n° 2013-701 du 10 octobre 2013 and décision n° 000010 ARSN/DG du 6 janvier 2026, after a mandatory inspection of the applicant's premises before the grant)45 days2-4 months—Verified
Croatia flagCroatia
HALMED
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
HALMED decision on entry in the register of distributors(National administrative decision under NN 100/2018 Article 9(2))30 days30-60 days—Verified
HALMED decision on a classification dispute between a manufacturer and a notified body(National administrative decision under NN 100/2018 Article 11(3)-(4))30-45 days30-45 days—Verified
Cuba flagCuba
CECMED
All classes — sanitary registration (registro sanitario)(CECMED state evaluation, then certificate issued by the direction on the Certification Commission result)90 working days6-12 months—Verified
All classes — renewal (prórroga del registro)(CECMED re-evaluation before the five-year certificate expires)60 working days4-9 months—Verified
Cyprus flagCyprus
Ministry of Health
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Czech Republic flagCzech Republic
SÚKL
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Denmark flagDenmark
Danish Medicines Agency
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Dominican Republic flagDominican Republic
DIGEMAPS
Sanitary registration — new registration (all sanitary products)(Registro Sanitario under Ley 42-01, Decreto 246-06 and Resolución 000020, filed on form DGDF-RP-FO-001 through the MSP Ventanilla Única de Servicios)90 working days3-6 months—Verified
Sanitary registration — renewal (all sanitary products)(Renovación del Registro Sanitario, filed within the three months before expiry; automatic on payment of the fee while the registration is in force)90 working days1-3 months—Verified
Ecuador flagEcuador
ARCSA
Standard registration (all classes)(ARCSA sanitary registration through the VUE single window)152 working days8-14 months—Verified
Recognition route (all classes)(Simplified registration recognising an IMDRF high-surveillance authority approval)95 working days5-9 months—Verified
Egypt flagEgypt
EDA
All classes — device holding an international quality certificate (imported or local)(EDA registration on the MeDevice platform under GL.CAMD.002)10-25 working days6-12 months—Verified
All classes — locally manufactured device with no international quality certificate(EDA registration under GL.CAMD.009 after a manufacturing-site inspection)30 working days1-2 years—Verified
Estonia flagEstonia
Ravimiamet
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Notification to Ravimiamet of the first distribution of a device on the Estonian market(National notification under MSS § 26(4))10 days10-20 days—Verified
Ravimiamet registration of a reported serious incident and acknowledgement to the reporter(National acknowledgement clock under MSS § 27(1))10 working days10-25 working days—Verified
Ravimiamet free-sale certificate(National certificate for export or for a foreign authority, under MSS § 32²)45 days45-60 days—Verified
European Union flagEuropean Union
EU MDR
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Finland flagFinland
Fimea
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
France flagFrance
ANSM
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Georgia flagGeorgia
Regulation Agency for Medical and Pharmaceutical Activities (RAMA)
Class I — clinical-investigation registration(Application to the Agency; registration certificate issued by decision of the Agency)20 working days2-4 months—Verified
Classes IIa, IIb and III — clinical-investigation registration on a Council recommendation(Application to the Agency; registration only on the positive recommendation of the Coordination Council for clinical investigations of medical devices)20 working days4-8 months—Verified
Any class — primary state registration under the Law on Medicines (national regime)(National regime of state registration, for the device-type categories the Law on Medicines registers: dental material, invasive mechanical means of contraception, and means of diagnostics)3 months5-9 months—Verified
Any class — re-registration and registration-and-recording under the Law on Medicines(National regime of state registration, re-registration after expiry of the five-year validity period)2 months4-7 months—Verified
Germany flagGermany
BfArM
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Ghana flagGhana
FDA Ghana
Medical-device registration (Class I-IV)(FDA Ghana registration)6 months7-10 months—Verified
Registration renewal (Class I-IV)(FDA Ghana renewal)3 months3-6 months—Verified
Minor variation(FDA Ghana variation)3 months3-5 months—Verified
Major variation(FDA Ghana variation)6 months6-9 months—Verified
GMP certificate for a foreign manufacturing facility(FDA Ghana facility certification)3 months3-6 months—Verified
Manufacturing licence for a local facility(FDA Ghana premises registration)4 weeks1-3 months—Verified
Greece flagGreece
EOF
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Guatemala flagGuatemala
MSPAS
Clase I — inscription without analysis (non-sterile, external use)(Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA in a natural-coloured folder)20 working days1-2 months—Verified
Clases II, III and IV — inscription with analysis(Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA)20 working days1-3 months—Verified
Renovación de la Inscripción Sanitaria (all classes)(Renewal under NT-37 Arts. 8-9, filed on form F-AS-f-08 before expiry; where nothing changed, proof of payment plus a notarised declaration and a copy of the previous certificate)15 working days1-2 months—Verified
IVD reagent — new inscription (Categorías I, II and III)(Inscripción Sanitaria under NT-40 v3-2015, filed with the DRCPFA in a black folder)20 working days1-2 months—Verified
IVD reagent — renewal (Categorías I, II and III)(Renewal under NT-40, filed with the DRCPFA)15 working days1-2 months—Verified
Hong Kong flagHong Kong
MDD
Class II(MDACS listing (Form MD101 via MDIS))12 weeks3-4 months—Verified
Class III(MDACS listing (Form MD101 via MDIS))12 weeks3-5 months—Verified
Class IV(MDACS listing (Form MD101 via MDIS))12 weeks3-6 months—Verified
Hungary flagHungary
NNGYK
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Iceland flagIceland
Lyfjastofnun
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
India flagIndia
CDSCO
Class A(Registration)45 days6-9 months3-5 monthsVerified
Class B(Registration)45-140 days8-12 months4-7 monthsVerified
Class C(Registration with clinical data)90 days1-1.5 years6-9 monthsVerified
Class D(Registration with extensive clinical)90 days1.3-2 years8-12 monthsVerified
Indonesia flagIndonesia
Ministry of Health
Class A(Notification)15 working days2-4 months—Verified
Class B(Registration)30 working days4-6 months—Verified
Class C(Full Registration)30 working days4-6 months—Verified
Class D(Full Registration)45 working days5-7 months—Verified
Iraq flagIraq
Ministry of Health
Laboratory devices, materials and supplies (الاجهزة والمواد والمستلزمات المختبرية) — all classes(MoH Technical Affairs evaluation via the UR national services portal)10 working days1-4 months—Verified
Ireland flagIreland
HPRA
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Israel flagIsrael
AMAR
Declaration track — Class I (incl. Is/Im/Ir) and low-risk IVDs(Declaration based on prior registration in a recognized state)1-2 days1-2 days—Verified
Fast track 1 — Class II (FDA approval), EU Class IIa, IVD Self Test/class B(Fast registration, channel 1 (one reference market))10-45 working days2-3 months—Verified
Fast track 2 — EU Class IIb, IVD LIST B/class C (two independent authorities)(Fast registration, channel 2 (two independent reference authorities))60 working days3-5 months—Verified
Regular track — all classes (standard route)(Regular registration (new, renewal and change applications))120 days4-8 months—Verified
Italy flagItaly
Ministry of Health
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Japan flagJapan
PMDA
Class I (一般医療機器)(Pre-marketing notification (製造販売届, Todokede) to PMDA)0 days0 days—Verified
Third-party certification (認証)(Registered certification body (登録認証機関) under Art. 23-2-23)0 days5-6 months—Verified
New medical device application (新医療機器)(PMDA approval review (Shonin))12 months7.1-12 months—Verified
Improved device — clinical data (改良医療機器（臨床あり）)(PMDA approval review (Shonin))9 months6.5-8.8 months—Verified
Improved device — no clinical data (改良医療機器（臨床なし）)(PMDA approval review (Shonin))6 months4.9-7.3 months—Verified
Follower medical device application (後発医療機器)(PMDA approval review (Shonin))4 months2-6 months—Verified
Jordan flagJordan
JFDA
Class I and Class IIa outside the Annex 7 list(No registration — import permission from the Director General only)0 days0 days—Verified
Class IIb and Class III(Registration by the Medical Devices and Supplies Committee)45 working days4-8 months—Verified
Any class listed in Annex 7, in pharmaceutical form, drug-containing, a surgical suture, a disinfectant or sterilant, or carrying a medical claim(Registration by the Medical Devices and Supplies Committee)45 working days4-8 months—Verified
Kazakhstan flagKazakhstan
Committee for Medical and Pharmaceutical Control
Class 1(KMPC registration)70 working days4-6 months—Verified
Class 2a(KMPC registration)70 working days4-6 months—Verified
Class 2b(KMPC registration)110 working days7-9 months—Verified
Class 3(KMPC registration)110 working days8-12 months—Verified
Kenya flagKenya
PPB
All classes — first in, first out(PPB marketing authorisation, default queue)2-2.3 years2-2.5 years—Verified
All classes — fast track (reliance route)(PPB marketing authorisation, priority queue)4-5 months5-9 months—Verified
All classes — expedited review (emergency use authorisation)(PPB emergency use authorisation)25-48 days1-3 months—Verified
Kuwait flagKuwait
Ministry of Health
CITRA new type approval — radiocommunications equipment(Application to CITRA with an official letter requesting type approval, the device's technical specifications, a manufacturer's authorization letter, a Declaration of Conformity for region 1 and a lab report from an approved laboratory; review and approval, fee payment, then issue and delivery of the type approval certificate)20 working days1-2 months—Verified
CITRA type approval renewal(Application to CITRA to renew the type approval, with an official letter to renew and a manufacturer's authorization letter; review and approval, fee payment, then issue and delivery)5 working days1-4 weeks—Verified
CITRA permit to import communications equipment(Application to CITRA with the completed services application form, the device's technical specifications and, where applicable, an authorization letter to CITRA for import of telecom devices naming the importing company; review and approval, then delivery of the authorization)3 working days1-2 weeks—Verified
Latvia flagLatvia
ZVA
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
ZVA publication of a IIa, IIb or III class device notification, which completes the notification procedure(National notification under § 9 of Cabinet Regulation No. 461)10 working days10-25 working days—Verified
ZVA entry of a manufacturer's or distributor's application into the LATMED database(National registration under §§ 28, 29 and 41.1 of Cabinet Regulation No. 461)10 days10-20 days—Verified
ZVA free-sale certificate for a device manufactured in Latvia(Paid service of the State Agency of Medicines under its published fee schedule)30 days30-45 days—Verified
Three-day signal report to ZVA after a serious incident or a potentially serious incident with a device(National vigilance clock under §§ 70 and 74.1 of Cabinet Regulation No. 461)3 days3-10 days—Verified
Lebanon flagLebanon
Ministry of Public Health
Entry and import approval for medical devices, instruments and supplies of all risk levels — form MPH12-26(Application on the official form to the Ministry of Public Health with the device invoice, the specifications catalogue and the letter of the beneficiary, together with the Atomic Energy Authority's import approval where the request calls for it; the invoice must bear the Atomic Energy stamp, the conformity certificate is issued by the Industrial Research Institute, and the Health Engineering Service then grants the entry permit)7-14 days1-2 months—Verified
Liechtenstein flagLiechtenstein
Office of Public Health
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Lithuania flagLithuania
VASPVT
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Luxembourg flagLuxembourg
Directorate of Health
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Macau flagMacau
ISAF
Class I(Formality review)5 working days1-2 months—Verified
Class IIa(Formality review)5 working days1-3 months—Verified
Class IIb(Registration)70 working days4-6 months—Verified
Class III(Registration)100 working days6-9 months—Verified
Malaysia flagMalaysia
MDA
Class A(Registration)14-20 working days1-3 months—Verified
Class B(Registration)30 working days3-6 months3-6 monthsVerified
Class C(Registration)30 working days3-6 months3-6 monthsVerified
Class D(Full Registration)30 working days3-6 months3-6 monthsVerified
Malta flagMalta
Medicines Authority
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Maltese organisation registration, device registration and free-sale certificate — standard service(National registration under S.L. 458.59, processed under the Schedule 5 standard service)30 days30-60 days—Verified
National derogation (MDR Art. 59 and 97, IVDR Art. 54 and 92) — application and renewal(Medicines Authority derogation under S.L. 458.46 Schedule 5)90 working days3-6 months—Verified
Maltese confirmation of risk classification — advisory service(Optional paid Medicines Authority confirmation under S.L. 458.46 Schedule 5)90 days3-4 months—Verified
Mexico flagMexico
COFEPRIS
Class I(Libre de Venta (LR) or Registration)30 days3 months—Verified
Class II(Registration or Equivalency)35 days1.3-2.6 years8-16 monthsVerified
Class III(Registration or Equivalency)60 days1.3-2.6 years8-16 monthsVerified
Moldova flagMoldova
AMDM
Classes I, IIA, IIB and III — registration in the State Register of medical devices for a device without the CE marking(Prior validation of the registration form, filing of the dossier at the Agency's single desk, and entry of the device data in the State Register of medical devices, under the procedure made in accordance with art. 8 of Legea nr. 102 din 9 iunie 2017)30 days1-3 months—Verified
Classes I, IIA, IIB and III — notification and registration of a device bearing the CE marking: AMDM examination period(Unified digital notification and registration procedure in the State Register of medical devices under Ordinul nr. Rg04-264 din 08.09.2026, Anexa 1, pct 19-20 and 32-35)10 working days1-2 months—Verified
Mongolia flagMongolia
Medicines and Medical Devices Regulatory Agency (MMRA)
Laboratory diagnostic devices (IVD) of medium and high risk (classes B, C, D) — state registration with a 5-year certificate(Registration dossier filed with the Agency through the E-business system, initial analysis and expert opinion by the working office, decision by the Medical Devices Council, certificate signed by the Agency head)55 working days3-6 months—Verified
Medical equipment and medical consumables of medium and high risk (grades IIa, IIb, III) — entry on the medical device list(Listing dossier to the Agency; initial analysis within 10 working days, sub-council opinion and referral within 10 working days, Medical Devices Council decision and issue of a registration number within 10 working days)30 working days4-8 months—Verified
Amendment of an existing medical device list entry (manufacturer, labels, packaging or stability change)(Amendment request to the Agency with the changed labelling artwork, risk assessment, stability data or the manufacturer's old and new ISO certificates, as applicable)10 working days1-3 months—Verified
Low-risk devices (grade I equipment and consumables, class A IVDs) — no registration and no list entry under Art. 33.9.1(Statutory exemption under Art. 33.9; an import declaration per consignment still applies to the Art. 33.9.1 to 33.9.8 categories)0 daysImmediate—Verified
Montenegro flagMontenegro
CInMED
Class I — registration of the medical device in the CInMED register(Application for entry in the register of medical devices, filed with CInMED before the device is placed on the market by the manufacturer established in Montenegro or by its authorised representative (čl. 38(1)))90 days3-6 months—Verified
Class IIa, IIb and III — registration of the medical device in the CInMED register(Application for entry in the register of medical devices after conformity has been determined by a notified or appointed body (čl. 18), filed by the manufacturer established in Montenegro or its authorised representative (čl. 38(1)))90 days4-9 months—Verified
Authorisation to import a medical device that is not registered (čl. 66)(Request to CInMED for authorisation to import an unregistered medical device)30 days1-2 months—Verified
Approval to start a clinical investigation of a medical device(Request to CInMED for approval to begin a clinical investigation, including a positive opinion of the ethics committee)40 days2-4 months—Verified
Amendment and renewal of a registration decision(Request to CInMED to amend or to renew a decision entering a medical device in the register)60 days2-3 months—Verified
Morocco flagMorocco
AMMPS
Initial device registration — all risk classes(National dossier review: the application is addressed to the Minister of Health and the certificat d'enregistrement is delivered by the administration after consultation of the commission nationale consultative des dispositifs médicaux (loi 84-12 arts. 12 and 14; décret n° 2-14-607 art. 4))120 days6-12 months—Verified
Post-registration update (mise à jour) of the certificate(Update application under arrêté n° 2855-15, distinct from a fresh registration application where the change bears on the nature of the device (loi 84-12 art. 16))20 days2-4 months—Verified
ANRT agrément — radio and telecommunications terminal equipment(Prior agrément by equipment, delivered by the ANRT on application to its services (Décision ANRT/DG/N°16/24 arts. 2, 3 and 11))15 days2-4 months—Verified
AMSSNuR authorisation — ionizing-radiation installations, activities and sources(Authorisation from the Agence for the installation or activity and the ionizing-radiation sources associated with it (loi n° 142-12 arts. 7 and 45))2-6 months6-12 months—Verified
Advertising of medical devices to the public — visa de publicité(Application for the visa de publicité addressed to the Minister of Health, on a dossier whose content and grant procedure are fixed by ministerial arrêté; the Minister decides after the opinion (avis) of the Commission nationale consultative des dispositifs médicaux (décret n° 2-14-607 art. 14, implementing art. 34 of loi n° 84-12))60 days3-6 months—Verified
Myanmar flagMyanmar
FDA Myanmar
Imported medical-device certificate(FDA Myanmar import review)30-90 working days3-6 months—Verified
Netherlands flagNetherlands
IGJ
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
New Zealand flagNew Zealand
Medsafe
All devices (WAND notification)(Notification to the Web Assisted Notification of Devices (WAND) database)0 days1-2 months—Verified
Nigeria flagNigeria
NAFDAC
Class A(NAFDAC registration)120 working days7-10 months—Verified
Class B(NAFDAC registration)240 working days1.1-1.5 years—Verified
Class C(NAFDAC registration)240 working days1.1-1.7 years—Verified
Class D(NAFDAC registration)240 working days1.2-2 years—Verified
North Macedonia flagNorth Macedonia
MALMED
Class I — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 1, with the documentation prescribed by чл. 7 of the 151/2010 rulebook for devices holding an EC certificate of conformity or by чл. 8 for devices without one)30 days2-4 months—Verified
Class II-а — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook)30 days2-4 months—Verified
Class II-б — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook)30 days2-4 months—Verified
Class III — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2, or on Образец бр. 4 for an active implantable medical device)30 days2-4 months—Verified
Parallel import — approval to place a parallel-imported medical device on the market(Application to MALMED on the parallel-import form ПУМПС under чл. 131-а of the Law, filed by a wholesaler holding a wholesale-trade approval; MALMED issues a provisional approval within eight working days of a complete file, and within three days of full payment of the fee issues the approval valid for two years, which supersedes the provisional one)8 working days8-21 months—Verified
Clinical investigation — MALMED approval or notification(Notification to, or approval by, MALMED of a clinical investigation of a medical device under чл. 133–135 of the Law; the investigation is deemed approved if MALMED does not decide within the statutory period)30 days2.5-5 years—Verified
Manufacturer, wholesale and specialised-retail registration — decision period(Application to MALMED for entry in the register of medical-device manufacturers (чл. 121 and 123), the register of legal persons for wholesale trade in medical devices (чл. 126 and 129) or the register of specialised retail shops (чл. 130))90 days7.5-10 years—Verified
Norway flagNorway
Norwegian Medical Products Agency
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Oman flagOman
Ministry of Health
Medical-device registration service(MoH registration)60 working days3-5 months—Verified
Medical-device manufacturer registration(MoH manufacturer registration)60 working days3-5 months—Verified
Medical-device re-registration(MoH re-registration)60 working days3-5 months—Verified
Import authorisation for a non-registered device(MoH import authorisation)30 working days1.5-3 months—Verified
Product classification ruling(MoH classification)30 working days1.5-3 months—Verified
Panama flagPanama
Ministry of Health
All classes — establishment licence (licencia de operación)(DNDM operating licence, required before any device may be imported, manufactured, stored or sold)45 working days3-6 months—Verified
All classes — technical-criterion certificate (certificado de criterio técnico)(DNDM product certificate, required for purchase by public health institutions)30 working days2-5 months—Verified
Paraguay flagParaguay
DINAVISA
Clases II, III y IV — Proceso simplificado de Registro Sanitario(Simplified registration under Resolución DINAVISA N° 226/2024 Art. 8(a): the applicant still files every Art. 6 requirement, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier)45 working days3-6 months—Verified
Clases II, III y IV — análisis integral del expediente(Integral registration under Resolución DINAVISA N° 226/2024 Art. 8(b): every Art. 6 item is evaluated)120 working days6-12 months—Verified
Dispositivos ya registrados — modificación Tipo II(Post-registration modification filed in DINAVISAPy; Resolución DINAVISA N° 226/2024 distinguishes Type I from Type II modifications)45 working days3-6 months—Verified
Productos para diagnóstico de uso in vitro — elaboración nacional y países incluidos en el Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022 on the general dossier of Arts. 4 and 5)30 working days2-4 months—Verified
Productos para diagnóstico de uso in vitro — elaborados fuera del Anexo I pero registrados y comercializados en un país del Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022, filing additionally the current Constancia de Registro Sanitario and Certificado de Libre Venta from the Annex I country)45 working days3-6 months—Verified
Productos para diagnóstico de uso in vitro — importados de países fuera del Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022 for imports from countries not included in Annex I)120 working days6-12 months—Verified
Productos para diagnóstico de uso in vitro Clases II, III y IV — Proceso Simplificado de Registro Sanitario (PSR)(Simplified registration under Resolución DINAVISA N° 44/2024 (Art. 7: classes II, III and IV) for IVDs already authorised and commercialised by a PAHO/WHO reference authority, an IMDRF Management Committee member authority, or an authority with a bilateral agreement with DINAVISA)15 working days1-2 months—Verified
Peru flagPeru
DIGEMID
Class I(Notification)22 working days2-4 months—Verified
Class II(Registration)44 working days4-8 months3-5 monthsVerified
Class III(Registration)66 working days6-12 months4-7 monthsVerified
Class IV(Full Registration)66 working days8-15 months5-8 monthsVerified
Philippines flagPhilippines
FDA Philippines
Class A(Notification)23 working days2-4 months—Verified
Class B(Registration)80 working days4-9 months3-5 monthsVerified
Class C(Registration)180 days6-12 months4-7 monthsVerified
Class D(Full Registration)180 days9-18 months6-10 monthsVerified
Poland flagPoland
URPL
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Portugal flagPortugal
INFARMED
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Romania flagRomania
ANMDMR
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Russia flagRussia
Roszdravnadzor
Class 1(RZN state registration (EAEU route))31-50 working days2-4 months—Verified
Class 2a(RZN state registration (EAEU route))31-50 working days3-5 months—Verified
Class 2b(RZN state registration (EAEU route))31-50 working days4-7 months—Verified
Class 3(RZN state registration (EAEU route))31-50 working days5-9 months—Verified
Rwanda flagRwanda
Rwanda FDA
Notification procedure(Notification of a medical device under DHT/GDL/024 section 1.10.1)20 days20-40 days—Verified
Abridged assessment procedure(Abridged assessment taking account of WHO prequalification or an SRA or EAC registration)60 days60-90 days—Verified
Full assessment procedure(Full assessment of the complete dossier under DHT/GDL/024 section 1.10.1)180 days180-240 days—Verified
Saudi Arabia flagSaudi Arabia
SFDA
Class A(MDMA Registration (Technical File Assessment))35 working days1.5-3 months—Verified
Class B(MDMA Registration)35 working days1.5-3 months—Verified
Class C(MDMA Registration)35 working days3-5 months—Verified
Class D(MDMA Registration)35 working days4-6 months—Verified
Senegal flagSenegal
Agence sénégalaise de Réglementation pharmaceutique (ARP)
Establishment agrément — manufacture, import, registration, export, distribution and maintenance of medical devices(Agrément d'établissement decided by the ARP Director-General (décret n° 2023-2419, art. 28; arrêté, arts. 2-14), after a prior inspection for manufacturing and wholesale-import establishments)3 months4-6 months—Verified
ARSN authorisation — device or installation using ionizing radiation(Autorisation issued by the ARSN under loi n° 2021-44 du 31 décembre 2021, with separate application forms for importation, exportation, détention et utilisation, and transport)15-30 days30-60 days—Verified
Serbia flagSerbia
ALIMS
Class I(ALIMS registration)30 days2-4 months—Verified
Class IIa(ALIMS registration)30 days2-4 months—Verified
Class IIb(ALIMS registration)30 days3-5 months—Verified
Class III(ALIMS registration)30 days3-6 months—Verified
Singapore flagSingapore
HSA
Class A(Notification)ImmediateImmediate—Verified
Class B(IBR/Expedited/Full Route)0-160 working days3-9 monthsImmediateVerified
Class C(IBR/Expedited/Full Route)0-220 working days6-12 monthsImmediateVerified
Class D(IBR/Expedited/Full Route)180-310 working days9-18 months6-12 monthsVerified
Slovakia flagSlovakia
ŠÚKL
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Slovenia flagSlovenia
JAZMP
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
South Africa flagSouth Africa
SAHPRA
Medical device establishment licence(SAHPRA establishment licensing)6-8 weeks2-4 months—Verified
Medical device establishment licence renewal4-8 weeks2-4 months—Verified
South Korea flagSouth Korea
MFDS
Class I (1등급)(Manufacture/import notification (제조·수입 신고))0 days0 days—Verified
Class II (2등급)(Certification (인증) by the Korea Institute of Medical Device Safety Information)5 working days3-6 months—Verified
Approval — no technical-document review(MFDS approval (허가))10 working days10-20 working days—Verified
Approval — technical-document review(MFDS approval (허가))65 working days6-12 months—Verified
Approval — clinical data review(MFDS approval (허가))80 working days10-15 months—Verified
Spain flagSpain
AEMPS
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Sweden flagSweden
Swedish Medical Products Agency
Class I(Self-declaration (no notified body))0 days6-9 months—Verified
Switzerland flagSwitzerland
Swissmedic
Class I(Self-declaration (no conformity assessment body))0 days3-5 months1-2 monthsVerified
Taiwan flagTaiwan
TFDA
Class I(Registration)80 days3-7 months—Verified
Class II(Registration)140 days9-14 months6-9 monthsVerified
Class III(Registration with clinical data)200 days1-1.5 years8-11 monthsVerified
No-predicate device(Registration of a device with no similar marketed product)220 days1-2 years—Verified
Tanzania flagTanzania
TMDA
Class A(TMDA registration)20-45 working days2-4 months—Verified
Class B(TMDA registration)20-45 working days2-5 months—Verified
Class C(TMDA registration)45 working days3-6 months—Verified
Class D(TMDA registration)45 working days4-8 months—Verified
Thailand flagThailand
Thai FDA
Class 1(Notification)200 days0-2 months—Verified
Class 2(Registration)250 days4-5 months—Verified
Class 3(Registration)250 days4-5 months—Verified
Class 4(Full Registration)300 days4-5 months—Verified
Tunisia flagTunisia
Agence Nationale du Médicament et des Produits de Santé (ANMPS)
CERT authorisation to withdraw a representative sample for homologation(Application to the CERT guichet unique with the form, invoice, arrival notice, technical documentation, certificate of origin and, where necessary, trade-register and tax identifiers)2 days1-2 weeks—Verified
CERT homologation certificate — radio and telecommunications terminal equipment(Homologation by the CERT services on an application filed with the guichet unique (décret gouvernemental n° 2020-48 du 23 janvier 2020))3-21 working days2-4 months—Verified
Turkey flagTurkey
TITCK
Class I (non-sterile, non-measuring, non-reusable)(Self-declaration, then ÜTS registration)0 days6-9 months—Verified
Uganda flagUganda
NDA
Surgical instruments and appliances — registration by the Authority(Application to the National Drug Authority for registration of a surgical instrument before manufacture, importation or exportation, on Form 7 of Schedule 6 to S.I. 2014 No. 29 (reg. 27(1)-(2)), filed by the patent holder, a licensed person, the manufacturer, or an agent authorised by the manufacturer or patent holder (reg. 27(3)); registration is a precondition of sale or distribution (reg. 25(1)))60 days2-6 months—Verified
Ukraine flagUkraine
DLS
Class I(Self-declaration under Annex 8)0 days2-4 months—Verified
United Arab Emirates flagUnited Arab Emirates
EDE
Class I(Registration)45 working days2-3 months—Verified
Class II(Registration)45 working days3-6 months—Verified
Class III(Registration)45 working days4-8 months—Verified
Class IV(Full Registration)45 working days6-12 months—Verified
United Kingdom flagUnited Kingdom
MHRA
Class I(Self-declaration (no approved body))0 days0.5-1 months2-3 weeksVerified
United States flagUnited States
FDA
510(k)(Premarket Notification)90 days6-12 months6-8 monthsVerified
De Novo(De Novo Classification)150 days8-15 months—Verified
PMA(Premarket Approval)180 days4-8 years4-6 yearsVerified
Uruguay flagUruguay
Ministry of Public Health
Medical-device registration(MSP registration)180 days7-10 months—Verified
Registration renewal(MSP renewal)180 days6-9 months—Verified
Uzbekistan flagUzbekistan
Pharmaceutical Safety Center
Class I(MoH registration)60 working days3-5 months—Verified
Class IIa(MoH registration)90 working days5-7 months—Verified
Class IIb(MoH registration)120 working days7-10 months—Verified
Class III(MoH registration)120 working days8-12 months—Verified
Vietnam flagVietnam
Ministry of Health
Class A(Declaration of applied standards (provincial Department of Health))0 days1-2 weeks—Verified
Class B(Declaration of applied standards (provincial Department of Health))0 days1-2 weeks—Verified
Class C(Circulation number registration (Ministry of Health))45 days4-5 months10 working daysVerified
Class D(Circulation number registration (Ministry of Health))45 days4-5 months10 working daysVerified
Zambia flagZambia
ZAMRA
Class A to D in-vitro diagnostic device — marketing authorisation(Marketing authorisation application to ZAMRA under s.39 of the Medicines and Allied Substances Act No. 3 of 2013, filed physically in duplicate with one hard and one soft copy of the full product dossier under ZAMRA/MA/GUD/0003)180 working days9-14 months—Verified
Class A to D non-IVD medical device — expedited evaluation (fast track)(Expedited evaluation authorised by the Authority, charged at double the applicable marketing authorisation fee)90 days4-8 months—Verified
Condoms — marketing authorisation under the dedicated condom guideline(Application to ZAMRA for marketing authorisation of a condom under s.39 of the Medicines and Allied Substances Act No. 3 of 2013, evaluated against the condom guideline's dossier requirements with laboratory analysis by the National Drug Quality Control Laboratory against ISO 4074:2015 (male) or ISO 25841:2014 (female), and tabled before the Technical Committee for approval)365 days1-1.5 years—Verified
Zimbabwe flagZimbabwe
MCAZ
Ionising-radiation import licence — radiation devices and radioactive sources (RPAZ)(Application to the Radiation Protection Authority of Zimbabwe for an import licence for a radiation device or radioactive source, under the Radiation Protection Act [Chapter 15:15] and the Radiation Protection (Safety and Security of Radiation Sources) Regulations (S.I. 62 of 2011))3 working days1-3 months—Verified
Licence to use a radiation device — new application and renewal (RPAZ)(Application to RPAZ for a licence to use a radiation device, in the prescribed form with the prescribed fee, under s.15(2) of the Radiation Protection Act [Chapter 15:15]; the licence is what authorises the holder to install, use, operate or dispose of an irradiating device under s.15(4)(b))30 days2-5 months—Verified
Design approval certificate — radiation device (RPAZ)(Application to RPAZ for a design approval certificate for a radiation device or its shielding, alongside the import and use licences)5 working days1-2 months—Verified
Review clocks exclude applicant hold time · planning totals are estimates
About the data

How timeline rows are verified

Review clocks marked verified link to the regulator's published target or statutory period and carry a review date. Unverified clocks and every end-to-end total are maintained planning benchmarks that include preparation, testing, and typical question rounds.

Timelines vary with submission quality, device class, and regulator workload, so use these ranges to sequence markets — not as commitments for a specific project.

akbpm.gov.al · Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13) miph.gov.dz · Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34) joradp.dz · Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9) joradp.dz · Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15) joradp.dz · Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours servicios.infoleg.gob.ar · Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Verified312 review clocks checked against primary regulator sources · Sep 16, 2026
What's the difference between a regulator clock and a planning total?
A regulator clock is an agency review target or statutory period; linked clocks are verified against primary sources. Planning totals add preparation, questions, stop-clock periods, and likely delays — they are estimates, not regulator commitments.
Which prior approvals help the most?
It depends on the target regulator and route. Singapore HSA publishes routes based on reference-agency approvals; for other markets, treat the displayed savings as planning hypotheses until the current route is confirmed.
Should I get MDSAP certification?
If you target multiple markets, usually yes: MDSAP is mandatory for Canada Class II-IV, extends Brazil B-GMP validity, and is accepted by Japan, Australia, and FDA — one audit can replace five separate regulatory audits.
Explore by country

Medical device registration timelines by country

Open a country timeline for class-specific approval estimates, pathways, local representative requirements, and related resources.

🇦🇱 Albania timelineAKBPM🇩🇿 Algeria timelineANPP🇦🇷 Argentina timelineANMAT🇦🇲 Armenia timelineMinistry of Health🇦🇺 Australia timelineTGA🇦🇹 Austria timelineBASG🇦🇿 Azerbaijan timelineMinistry of Health🇧🇭 Bahrain timelineNHRA🇧🇩 Bangladesh timelineDGDA🇧🇾 Belarus timelineMinistry of Health🇧🇪 Belgium timelineFAMHP🇧🇴 Bolivia timelineAGEMED🇧🇦 Bosnia and Herzegovina timelineALMBiH🇧🇼 Botswana timelineBoMRA🇧🇷 Brazil timelineANVISA🇧🇬 Bulgaria timelineBDA🇰🇭 Cambodia timelineDepartment of Drugs and Food🇨🇦 Canada timelineHealth Canada🇨🇱 Chile timelineISP/ANDIM🇨🇳 China timelineNMPA🇨🇴 Colombia timelineINVIMA🇨🇷 Costa Rica timelineMinistry of Health🇨🇮 Côte d'Ivoire timelineAIRP🇭🇷 Croatia timelineHALMED🇨🇺 Cuba timelineCECMED🇨🇾 Cyprus timelineMinistry of Health🇨🇿 Czech Republic timelineSÚKL🇩🇰 Denmark timelineDanish Medicines Agency🇩🇴 Dominican Republic timelineDIGEMAPS🇪🇨 Ecuador timelineARCSA🇪🇬 Egypt timelineEDA🇪🇪 Estonia timelineRavimiamet🇪🇺 European Union timelineEU MDR🇫🇮 Finland timelineFimea🇫🇷 France timelineANSM🇬🇪 Georgia timelineRegulation Agency for Medical and Pharmaceutical Activities (RAMA)🇩🇪 Germany timelineBfArM🇬🇭 Ghana timelineFDA Ghana🇬🇷 Greece timelineEOF🇬🇹 Guatemala timelineMSPAS🇭🇰 Hong Kong timelineMDD🇭🇺 Hungary timelineNNGYK🇮🇸 Iceland timelineLyfjastofnun🇮🇳 India timelineCDSCO🇮🇩 Indonesia timelineMinistry of Health🇮🇶 Iraq timelineMinistry of Health🇮🇪 Ireland timelineHPRA🇮🇱 Israel timelineAMAR🇮🇹 Italy timelineMinistry of Health🇯🇵 Japan timelinePMDA🇯🇴 Jordan timelineJFDA🇰🇿 Kazakhstan timelineCommittee for Medical and Pharmaceutical Control🇰🇪 Kenya timelinePPB🇰🇼 Kuwait timelineMinistry of Health🇱🇻 Latvia timelineZVA🇱🇧 Lebanon timelineMinistry of Public Health🇱🇮 Liechtenstein timelineOffice of Public Health🇱🇹 Lithuania timelineVASPVT🇱🇺 Luxembourg timelineDirectorate of Health🇲🇴 Macau timelineISAF🇲🇾 Malaysia timelineMDA🇲🇹 Malta timelineMedicines Authority🇲🇽 Mexico timelineCOFEPRIS🇲🇩 Moldova timelineAMDM🇲🇳 Mongolia timelineMedicines and Medical Devices Regulatory Agency (MMRA)🇲🇪 Montenegro timelineCInMED🇲🇦 Morocco timelineAMMPS🇲🇲 Myanmar timelineFDA Myanmar🇳🇱 Netherlands timelineIGJ🇳🇿 New Zealand timelineMedsafe🇳🇬 Nigeria timelineNAFDAC🇲🇰 North Macedonia timelineMALMED🇳🇴 Norway timelineNorwegian Medical Products Agency🇴🇲 Oman timelineMinistry of Health🇵🇦 Panama timelineMinistry of Health🇵🇾 Paraguay timelineDINAVISA🇵🇪 Peru timelineDIGEMID🇵🇭 Philippines timelineFDA Philippines🇵🇱 Poland timelineURPL🇵🇹 Portugal timelineINFARMED🇷🇴 Romania timelineANMDMR🇷🇺 Russia timelineRoszdravnadzor🇷🇼 Rwanda timelineRwanda FDA🇸🇦 Saudi Arabia timelineSFDA🇸🇳 Senegal timelineAgence sénégalaise de Réglementation pharmaceutique (ARP)🇷🇸 Serbia timelineALIMS🇸🇬 Singapore timelineHSA🇸🇰 Slovakia timelineŠÚKL🇸🇮 Slovenia timelineJAZMP🇿🇦 South Africa timelineSAHPRA🇰🇷 South Korea timelineMFDS🇪🇸 Spain timelineAEMPS🇸🇪 Sweden timelineSwedish Medical Products Agency🇨🇭 Switzerland timelineSwissmedic🇹🇼 Taiwan timelineTFDA🇹🇿 Tanzania timelineTMDA🇹🇭 Thailand timelineThai FDA🇹🇳 Tunisia timelineAgence Nationale du Médicament et des Produits de Santé (ANMPS)🇹🇷 Turkey timelineTITCK🇺🇬 Uganda timelineNDA🇺🇦 Ukraine timelineDLS🇦🇪 United Arab Emirates timelineEDE🇬🇧 United Kingdom timelineMHRA🇺🇸 United States timelineFDA🇺🇾 Uruguay timelineMinistry of Public Health🇺🇿 Uzbekistan timelinePharmaceutical Safety Center🇻🇳 Vietnam timelineMinistry of Health🇿🇲 Zambia timelineZAMRA🇿🇼 Zimbabwe timelineMCAZ