Use the searchable library below to access Hopestone’s free IVD regulatory country guides for Priority A and Priority B markets.
| Country | Product Area | Region | Priority | Authority | Updated | Guide |
|---|---|---|---|---|---|---|
| ๐ฆ๐บ Australia | IVD | Asia-Pacific | Priority A | TGA – Therapeutic Goods Administration | 2026-08-17 | Download PDF |
| ๐ฆ๐น Austria | IVD | Europe | Priority B | BASG / AGES Medical Market Supervision | 2026-08-17 | Download PDF |
| ๐ง๐ช Belgium | IVD | Europe | Priority B | FAMHP – Federal Agency for Medicines and Health Products | 2026-08-17 | Download PDF |
| ๐ง๐ท Brazil | IVD | Latin America | Priority A | ANVISA | 2026-08-17 | Download PDF |
| ๐จ๐ฆ Canada | IVD | North America | Priority A | Health Canada | 2026-08-17 | Download PDF |
| ๐จ๐ณ China | IVD | Asia-Pacific | Priority A | NMPA | 2026-08-17 | Download PDF |
| ๐ฉ๐ฐ Denmark | IVD | Europe | Priority B | Danish Medicines Agency | 2026-08-17 | Download PDF |
| ๐ช๐บ European Union | IVD | Europe | Priority A | EU IVDR framework / national competent authorities / notified bodies | 2026-08-17 | Download PDF |
| ๐ซ๐ท France | IVD | Europe | Priority A | ANSM | 2026-08-17 | Download PDF |
| ๐ฉ๐ช Germany | IVD | Europe | Priority A | BfArM / PEI | 2026-08-17 | Download PDF |
| ๐ฎ๐ณ India | IVD | Asia-Pacific | Priority A | CDSCO | 2026-08-17 | Download PDF |
| ๐ฎ๐ฑ Israel | IVD | Middle East | Priority B | AMAR – Medical Device Division, Ministry of Health | 2026-08-17 | Download PDF |
| ๐ฎ๐น Italy | IVD | Europe | Priority A | Italian Ministry of Health | 2026-08-17 | Download PDF |
| ๐ฏ๐ต Japan | IVD | Asia-Pacific | Priority A | PMDA / MHLW | 2026-08-17 | Download PDF |
| ๐ฒ๐ฝ Mexico | IVD | Latin America | Priority B | COFEPRIS | 2026-08-17 | Download PDF |
| ๐ณ๐ฑ Netherlands | IVD | Europe | Priority B | IGJ / CIBG-Farmatec | 2026-08-17 | Download PDF |
| ๐ณ๐ด Norway | IVD | Europe | Priority B | Norwegian Medical Products Agency (DMP) | 2026-08-17 | Download PDF |
| ๐ต๐ฑ Poland | IVD | Europe | Priority B | URPL – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | 2026-08-18 | Download PDF |
| ๐ฐ๐ท Republic of Korea | IVD | Asia-Pacific | Priority A | MFDS – Ministry of Food and Drug Safety | 2026-08-17 | Download PDF |
| ๐ท๐บ Russian Federation | IVD | Eurasia | Priority B | Roszdravnadzor | 2026-08-17 | Download PDF |
| ๐ธ๐ฆ Saudi Arabia | IVD | Middle East | Priority B | SFDA – Saudi Food and Drug Authority | 2026-08-18 | Download PDF |
| ๐ธ๐ฌ Singapore | IVD | Asia-Pacific | Priority A | HSA – Health Sciences Authority | 2026-08-17 | Download PDF |
| ๐ช๐ธ Spain | IVD | Europe | Priority B | AEMPS – Spanish Agency of Medicines and Medical Devices | 2026-08-18 | Download PDF |
| ๐ธ๐ช Sweden | IVD | Europe | Priority B | Swedish Medical Products Agency (MPA) | 2026-08-18 | Download PDF |
| ๐จ๐ญ Switzerland | IVD | Europe | Priority B | Swissmedic | 2026-08-18 | Download PDF |
| ๐น๐ผ Taiwan | IVD | Asia-Pacific | Priority B | TFDA – Taiwan Food and Drug Administration | 2026-08-17 | Download PDF |
| ๐น๐ท Tรผrkiye | IVD | Europe / Middle East | Priority B | TฤฐTCK – Turkish Medicines and Medical Devices Agency | 2026-08-18 | Download PDF |
| ๐ฌ๐ง United Kingdom | IVD | Europe | Priority A | MHRA | 2026-08-17 | Download PDF |
| ๐บ๐ธ United States | IVD | North America | Priority A | FDA / CDRH | 2026-08-17 | Download PDF |