All topics
Regulator lookup
Medical Device Regulatory Authorities Directory
A single-page directory of the national medical device regulator, governing law, and official regulatory website for every country in this library — the fastest answer to 'who regulates medical devices' in a given market.
Overview
This directory lists the national medical device regulator, the governing law or framework, and the official regulatory website for every country covered in this library, grouped by region. It is the single reference for 'who regulates medical devices in X' and 'what is the regulatory body for medical devices in X' across Asia, the Americas, Europe, and the Middle East & Africa. Each country name links to the full regulatory report for that market — registration pathway, timeline, cost, and local-holder requirements.
Regulators by country
Asia
| Country | Regulator | Governing law | Official website | Note |
|---|---|---|---|---|
| Australia | Therapeutic Goods Administration (TGA) | Therapeutic Goods Act 1989 | https://www.tga.gov.au | Every device must be listed or registered in the ARTG (Australian Register of Therapeutic Goods) before sale. |
| China | National Medical Products Administration (NMPA) | Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739) | https://www.nmpa.gov.cn | The registration certificate is issued in the foreign manufacturer's own name via a Domestic Responsible Agent, who does not hold the certificate. |
| India | Central Drugs Standard Control Organisation (CDSCO) | Medical Device Rules 2017 (MDR 2017) | https://cdsco.gov.in | Import licences are always issued by CDSCO's Central Licensing Authority (CLA), regardless of device class. |
| Indonesia | Ministry of Health / Kemenkes (Regalkes) | Permenkes No. 62/2017 | https://regalkes.kemkes.go.id | Class A devices containing animal-derived materials must complete halal certification by 18 October 2026. |
| Japan | Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare (MHLW) | PMD Act (Act No. 84 of 2013) | https://www.pmda.go.jp | IVDs are legally classified as pharmaceuticals, not medical devices, under the PMD Act. |
| Malaysia | Medical Device Authority (MDA) | Medical Device Act 2012 (Act 737) | https://www.mda.gov.my | A formal CE-recognition mechanism gives Class A/B devices a simplified registration pathway. |
| Philippines | FDA Philippines / CDRRHR | Republic Act No. 9711 (FDA Act of 2009) | https://www.fda.gov.ph | The ~30-business-day abridged route is reserved for devices already approved by any ASEAN member NRA, not CE/FDA approval alone. |
| Singapore | Health Sciences Authority (HSA) | Health Products Act (HPA, 2007) | https://www.hsa.gov.sg | The region's most foreign-friendly holder model — a flexible Registrant structure rather than a mandatory local distributor. |
| South Korea | Ministry of Food and Drug Safety (MFDS) | Medical Devices Act (의료기기법) | https://www.mfds.go.kr/eng | The Korea License Holder (KLH) always owns the Import Item License; a foreign manufacturer cannot hold it directly. |
| Taiwan | Taiwan Food and Drug Administration (TFDA) | Medical Devices Act (醫療器材管理法) | https://www.fda.gov.tw | A Notified Body-issued CE certificate can support TFDA's Abbreviated Technical File route, roughly 40% faster. |
| Thailand | Thai Food and Drug Administration (Thai FDA / TFDA) | Medical Device Act B.E. 2551 (2008), as amended by (No. 2) B.E. 2562 (2019) | https://en.fda.moph.go.th | CE and FDA sit on TFDA's six-agency reference list, unlocking Expedited Review that can roughly halve Class 2-4 review time. |
| Vietnam | Ministry of Health (MOH), device review via DAV/DMEC | Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP | https://dichvucong.moh.gov.vn | Vietnamese-language labelling is mandatory for both the product label and the Instructions for Use. |
Americas
| Country | Regulator | Governing law | Official website | Note |
|---|---|---|---|---|
| Argentina | Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) | Ley 16.463/1964; Disposición ANMAT 64/2025 | https://www.argentina.gob.ar/anmat | Reference-country reliance (Decreto 892/25) lets Clase I/II devices skip local testing entirely via a sworn-declaration notification. |
| Brazil | Agência Nacional de Vigilância Sanitária (ANVISA) | RDC 751/2022 | https://www.gov.br/anvisa/pt-br | Full Registro certificates are valid for 10 years, the longest standard validity period in the Americas. |
| Canada | Health Canada, Medical Devices Bureau (MDB) | Medical Devices Regulations (SOR/98-282) | https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html | Foreign manufacturers do not need a Canadian licence themselves, but the local importer/distributor must hold a Medical Device Establishment Licence (MDEL) for every class, including Class I. |
| Chile | Instituto de Salud Pública de Chile (ISP), ANAMED division | DFL 725/1968 (Código Sanitario); DS 825/1998 | https://www.ispch.cl | Foreign manufacturers must appoint a local Director Técnico — a qualified physician, biomedical engineer, or pharmacist registered with ISP. |
| Colombia | Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) | Decreto 4725 de 2005, as modified by Decreto 582 de 2017 | https://www.invima.gov.co | Registro Sanitario is valid for 10 years, one of the longest cycles in the region. |
| Mexico | Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) | Reglamento de Insumos para la Salud (RIS), under the Ley General de Salud | https://www.gob.mx/cofepris | Unlike Brazil, the Registro Sanitario itself can be held directly in the foreign manufacturer's own name. |
| United States | Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) | Federal Food, Drug, and Cosmetic Act (FD&C Act) | https://www.fda.gov/medical-devices | The 510(k) premarket notification pathway, based on substantial equivalence to a predicate device, covers roughly 90% of all device submissions. |
Europe
| Country | Regulator | Governing law | Official website | Note |
|---|---|---|---|---|
| European Union | National Competent Authorities, coordinated by the European Commission (DG SANTE) / MDCG — no single EU-level approval authority | EU MDR 2017/745 | https://eur-lex.europa.eu | Conformity assessment for Class IIa and above is carried out by third-party Notified Bodies, not a government regulator directly. |
| Russia & EAEU | Roszdravnadzor (Federal Service for Surveillance in Healthcare) | TR EAEU 017/2011 | https://www.roszdravnadzor.gov.ru | The unified EAEU technical regulation applies across all five member states (Russia, Kazakhstan, Belarus, and others). |
| Switzerland | Swissmedic | Medical Devices Ordinance (MedDV / OMéd), SR 812.213 | https://www.swissmedic.ch | The Switzerland-EU Mutual Recognition Agreement covering medical devices is currently in a partially suspended state. |
| Turkey | Turkish Medicines and Medical Devices Agency (TITCK) | Medical Devices Regulation (Tıbbi Cihaz Yönetmeliği) | https://www.titck.gov.tr | CE marking is a mandatory prerequisite for market access, not an optional accelerator. |
| United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) | UK MDR 2002 (SI 2002/618) | https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency | Northern Ireland continues to apply EU MDR/IVDR under the Windsor Framework rather than UKCA marking. |
| Ukraine | Ministry of Health of Ukraine (МОЗ) / State Service on Medicines and Drugs Control | Technical Regulations on Medical Devices, Cabinet of Ministers Resolution No. 753 (2013) | https://moz.gov.ua | EU-candidate status since June 2022 is driving a gradual transition of the national framework toward EU MDR/IVDR. |
Middle East & Africa
| Country | Regulator | Governing law | Official website | Note |
|---|---|---|---|---|
| Egypt | Egyptian Drug Authority (EDA) | EDA Establishment Law (Law No. 151 of 2019) | https://edaegypt.gov.eg | Key documents must pass a full authentication chain, including mandatory Consular Legalization by the Egyptian Embassy in the country of origin. |
| Iran | Islamic Republic of Iran Food and Drug Administration (IFDA) | IFDA/MOHME medical-equipment regulations (specific statute not identified in current sources) | — | A locally established Iranian company must act as agent/importer; no verified evidence a foreign manufacturer can hold the registration directly. |
| Israel | Ministry of Health of Israel (MOH), via AMAR | Medical Devices Law 5772-2012 | https://www.health.gov.il/English/Topics/MedicalEquipment/Pages/default.aspx | Devices with FDA or EU CE approval can use AMAR's Reference Market Accelerated Pathway, which substantially simplifies technical review. |
| Kenya | Pharmacy and Poisons Board (PPB) | Pharmacy and Poisons Act (Cap 244) | https://www.ppb.go.ke | Registration is filed by a local authorized agent through the PPB eRegulations Portal; higher classes may trigger external expert review. |
| Kuwait | Kuwait Ministry of Health (MOH) | Ministerial Decree No. 341/2005 | https://www.moh.gov.kw | Part of the GCC Medical Devices Technical Regulations harmonization framework alongside Saudi Arabia and other Gulf states. |
| Nigeria | National Agency for Food and Drug Administration and Control (NAFDAC) | NAFDAC Act (CAP N1 LFN 2004) | https://www.nafdac.gov.ng | NAFDAC classification sometimes diverges from international GHTF practice, so classification should be confirmed locally before registration. |
| Saudi Arabia | Saudi Food and Drug Authority (SFDA) | Medical Devices Interim Regulation (MDIR) | https://www.sfda.gov.sa | An MDMA (Medical Device Marketing Authorization) is required for every risk class, A through D — there is no notification-only exemption. |
| South Africa | South African Health Products Regulatory Authority (SAHPRA) | Medicines and Related Substances Act 101 of 1965 (as amended 2015) | https://www.sahpra.org.za | Class A/B devices use a lighter Listing/Registration pathway; Class C/D require full registration review with a complete Technical File. |
| United Arab Emirates | MOHAP (federal) / DHA (Dubai) / DOH (Abu Dhabi) | Federal Law No. 4 of 1983 (MOHAP level) | https://mohap.gov.ae | Covering the full UAE market typically requires separate registrations with MOHAP, DHA, and DOH. |
How to use this directory
Start with the region and country you are targeting, then click through to the full country page for the registration pathway, timeline, cost, and local-holder structure — this table is a locator, not a substitute for the underlying regulatory detail. If you are planning entry across a whole region rather than a single country, the Southeast Asia and Japan/South Korea market-entry playbooks lay out a suggested entry sequence and a country-by-country delta table for those clusters. For the complete set of country reports, browse the countries index.
Each country name links to the full regulatory report for that market.