Country Intelligence
Source-aware intelligence for global healthcare markets
Compare regulatory, reimbursement, payer, procurement, and stakeholder context by country - with source status and professional review expectations kept visible.
Full Intelligence Profiles
10-section deep-dive profiles with sourced data, regulatory pathways, business intelligence, and AI recommendations.
North America
Europe
France
Europe
ANSM (Agence nationale de sécurité du médicament et des produits de santé) — national competent authority. EU MDR applies; CE Mark via EU Notified Bodies (BSI, TÜV, DEKRA, SGS, etc.).
Germany
Europe
No single national authority for EU MDR. Notified Bodies (BSI, TÜV SÜD, TÜV Rheinland, DEKRA) certify devices. BfArM (Federal Institute for Drugs and Medical Devices) handles vigilance and post-market surveillance.
Italy
Europe
ISS (Istituto Superiore di Sanità) and Ministero della Salute for national competent authority functions. EU MDR applies; CE Mark via EU Notified Bodies. AIFA for pharmaceutical-adjacent combination products.
Netherlands
Europe
IGJ (Health and Youth Care Inspectorate) is the competent authority; CIBG/Farmatec handles EUDAMED economic-operator registration and NOTIS national notifications.
Norway
Europe
Norwegian Medicines Agency (NOMA / Legemiddelverket) under the Ministry of Health and Care Services oversees medical device evaluation, authorization, and post-market surveillance.
Poland
Europe
URPL (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products) is the central regulatory authority for medical devices in Poland.
Russia
Europe
Roszdravnadzor (Federal Service for Surveillance in Healthcare), under the Ministry of Health, is the central authority for medical device registration, quality, and post-market surveillance.
Spain
Europe
AEMPS (Agencia Española de Medicamentos y Productos Sanitarios — Spanish Agency for Medicines and Medical Devices) is the national competent authority under EU MDR/IVDR.
Sweden
Europe
Läkemedelsverket (Swedish Medical Products Agency, MPA), under the Ministry of Health and Social Affairs, is the national competent authority for medical devices under EU MDR/IVDR.
Switzerland
Europe
Swissmedic (Swiss Agency for Therapeutic Products) is the national regulatory authority for medical devices and pharmaceuticals; Switzerland is not an EU member but aligns closely with EU MDR/IVDR via a Mutual Recognition Agreement framework.
Turkey
Europe
TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency)
United Kingdom
Europe
MHRA (Medicines and Healthcare products Regulatory Agency)
Asia Pacific
China
Asia Pacific
NMPA (National Medical Products Administration) — formerly CFDA / SFDA
India
Asia Pacific
CDSCO (Central Drugs Standard Control Organisation) — under Ministry of Health & Family Welfare
Indonesia
Asia Pacific
BPOM (Badan Pengawas Obat dan Makanan — National Agency of Drug and Food Control) regulates medical devices jointly with the Ministry of Health (Kemenkes) under the Permenkes (Ministerial Regulation) framework.
Japan
Asia Pacific
PMDA (Pharmaceuticals and Medical Devices Agency) + MHLW (Ministry of Health, Labour and Welfare)
Pakistan
Asia Pacific
DRAP (Drug Regulatory Authority of Pakistan) regulates medical devices under the Medical Device Rules 2017 (effective 16 January 2018).
South Korea
Asia Pacific
MFDS (Ministry of Food and Drug Safety)
Thailand
Asia Pacific
Thai FDA (Food and Drug Administration), specifically its Medical Device Control Division (MDCD), regulates medical devices under the Medical Device Act B.E. 2551 (2008) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019, effective 2021).
Latin America
Argentina
Latin America
ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica — National Administration of Drugs, Foods and Medical Technology) regulates medical devices in Argentina.
Brazil
Latin America
ANVISA (Agência Nacional de Vigilância Sanitária) — Medical Device Regulation
Colombia
Latin America
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos — National Food and Drug Surveillance Institute) regulates medical devices in Colombia.
Mexico
Latin America
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios — Federal Commission for Protection against Sanitary Risk) regulates medical devices in Mexico.
Middle East
Israel
Middle East
AMAR (Medical Device Division of the Israeli Ministry of Health) regulates medical devices under the Medical Equipment Law (2012) and its associated Regulations for Medical Equipment Registration.
Saudi Arabia
Middle East
SFDA (Saudi Food & Drug Authority) — Medical Device Sector
United Arab Emirates
Middle East
MOHAP (Ministry of Health and Prevention) — federal. DHA (Dubai Health Authority) for Dubai. DoH (Department of Health) Abu Dhabi. HAAD (historical Abu Dhabi authority — now DoH).
Africa
Egypt
Africa
The Egyptian Drug Authority (EDA), through its Central Administration of Medical Devices, is the current regulatory body for medical devices in Egypt. (Some older market materials reference 'EGMDB' — this appears to be a legacy/informal name for the same registration function, now consolidated under EDA's Central Administration of Medical Devices.)
Kenya
Africa
The Pharmacy and Poisons Board (PPB), through its Department of Product Evaluation and Registration (DPER), regulates medical devices including in vitro diagnostics in Kenya; the Kenya Bureau of Standards (KEBS) handles standards conformity for certain product categories.
Mali
Africa
The Direction de la Pharmacie et du Médicament (DPM — Directorate of Pharmacy and Medicine), under the Ministry of Health and Social Development (MSDS), serves as Mali's National Pharmaceutical Regulatory Authority (ANRP) function, covering both pharmaceuticals and, to a more limited degree, medical devices.
Nigeria
Africa
NAFDAC (National Agency for Food and Drug Administration and Control) regulates medical devices in Nigeria, recently updated via the NAFDAC Medical Device and Related Products Regulations 2024.
South Africa
Africa
SAHPRA (South African Health Products Regulatory Authority) regulates medical devices in South Africa.
Oceania
Australia
Oceania
TGA (Therapeutic Goods Administration) — part of the Australian Department of Health
New Zealand
Oceania
Medsafe (New Zealand Medicines and Medical Devices Safety Authority), part of the Ministry of Health, oversees medical device market entry.