Medical device country guides are planned for future release. This section will use the same scalable guide library structure.
| Country | Product Area | Region | Priority | Authority | Updated | Guide |
|---|---|---|---|---|---|---|
| 🇦🇺 Australia | Medical Device | Asia-Pacific | Priority B | TGA – Therapeutic Goods Administration | 2026-08-18 | Download PDF |
| 🇦🇹 Austria | Medical Device | Europe | Priority B | BASG / Austrian Federal Office for Safety in Health Care | 2026-08-18 | Download PDF |
| 🇧🇪 Belgium | Medical Device | Europe | Priority B | FAMHP – Federal Agency for Medicines and Health Products | 2026-08-18 | Download PDF |
| 🇧🇷 Brazil | Medical Device | Latin America | Priority B | ANVISA | 2026-08-18 | Download PDF |
| 🇨🇦 Canada | Medical Device | North America | Priority A | Health Canada | 2026-08-18 | Download PDF |
| 🇨🇳 China | Medical Device | Asia-Pacific | Priority A | NMPA | 2026-08-18 | Download PDF |
| 🇩🇰 Denmark | Medical Device | Europe | Priority B | Danish Medicines Agency | 2026-08-18 | Download PDF |
| 🇪🇺 European Union | Medical Device | Europe | Priority A | EU MDR framework / national competent authorities / notified bodies | 2026-08-18 | Download PDF |
| 🇫🇷 France | Medical Device | Europe | Priority A | ANSM | 2026-08-18 | Download PDF |
| 🇩🇪 Germany | Medical Device | Europe | Priority A | BfArM / competent authorities | 2026-08-18 | Download PDF |
| 🇮🇳 India | Medical Device | Asia-Pacific | Priority B | CDSCO | 2026-08-18 | Download PDF |
| 🇮🇱 Israel | Medical Device | Middle East | Priority B | AMAR – Medical Device Division, Ministry of Health | 2026-08-18 | Download PDF |
| 🇮🇹 Italy | Medical Device | Europe | Priority A | Italian Ministry of Health | 2026-08-18 | Download PDF |
| 🇯🇵 Japan | Medical Device | Asia-Pacific | Priority A | PMDA / MHLW | 2026-08-18 | Download PDF |
| 🇲🇽 Mexico | Medical Device | Latin America | Priority B | COFEPRIS | 2026-08-18 | Download PDF |
| 🇳🇱 Netherlands | Medical Device | Europe | Priority B | IGJ / CIBG-Farmatec | 2026-08-18 | Download PDF |
| 🇳🇴 Norway | Medical Device | Europe | Priority B | Norwegian Medical Products Agency (DMP) | 2026-08-18 | Download PDF |
| 🇵🇱 Poland | Medical Device | Europe | Priority B | URPL – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | 2026-08-18 | Download PDF |
| 🇰🇷 Republic of Korea | Medical Device | Asia-Pacific | Priority B | MFDS – Ministry of Food and Drug Safety | 2026-08-18 | Download PDF |
| 🇷🇺 Russian Federation | Medical Device | Eurasia | Priority B | Roszdravnadzor | 2026-08-18 | Download PDF |
| 🇸🇦 Saudi Arabia | Medical Device | Middle East | Priority B | SFDA – Saudi Food and Drug Authority | 2026-08-18 | Download PDF |
| 🇸🇬 Singapore | Medical Device | Asia-Pacific | Priority B | HSA – Health Sciences Authority | 2026-08-18 | Download PDF |
| 🇬🇧 United Kingdom | Medical Device | Europe | Priority A | MHRA | 2026-08-18 | Download PDF |
| 🇺🇸 United States | Medical Device | North America | Priority A | FDA / CDRH | 2026-08-18 | Download PDF |