Review Article
Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan
Table 1
Taiwan GMP requirement for medical devices.
| Classification | Class I | Class II | Class III |
| Number of medical device classification names (2014) | 737 | 936 | 153 |
| GMP | Not required | Required for sterile devices or devices with measuring function | Required for all Class II medical devices | Required for all Class III medical devices |
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