Taiwan Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Taiwan.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Annex II - Regulations for Governing the Management of Medical Devices | Annex II, art. 4 | 09/2014 | English |
| Download | Pharmaceutical Affairs Act | TW-1 | 2013.12.11 | English |
| Download | Regulations Governing Management of Medical Devices | TW-001 | 06/2005 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Guidelines for Registration of Medical Devices | TW-002 | 04/2006 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | How to apply for Medical Device License in Taiwan | TW-003 | English |
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