Taiwan Medical Device Regulations
All documents listed below were published by the Taiwanese Department of Health and are in PDF format.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Annex II - Regulations for Governing the Management of Medical Devices | en | Annex II, art. 4 | 09/2014 |
| Pharmaceutical Affairs Act | en | TW-1 | 2013.12.11 |
| Regulations Governing Management of Medical Devices | en | TW-001 | 06/2005 |
General Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Guidelines for Registration of Medical Devices | en | TW-002 | 04/2006 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| How to apply for Medical Device License in Taiwan | en | TW-003 | 09/2014 |