All documents listed below were published by the Taiwanese Department of Health and are in PDF format.
| 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 |
| Document | Language | Number | Published |
|---|---|---|---|
| Guidelines for Registration of Medical Devices | en | TW-002 | 04/2006 |
| Document | Language | Number | Published |
|---|---|---|---|
| How to apply for Medical Device License in Taiwan | en | TW-003 | 09/2014 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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