Public Notice on Amendment to Notification on 「GMP for Medical Devices」 (MFDS Notification No. 2013-219, Sep. 16th,2013)
1. Background of the Amendments
Class Ⅰ medical devices with little risk are exempted for inspections on Compliance with the Good Manufacturing Practice(GMP) for medical devices.
The amendment was made because Class Ⅰ medical devices (66 registered items) were investigated by the Ministry of Food and Drug Safety(MFDS), which have resulted in review process with bigger backlog and inefficiency.
This amendment intends to as follows.
- help manufacturers enter early into a market
- lower costs for manufacturers/distributors, and
- make the regulation focused more on medical devices with higher level of risk, and thus more efficient.
2. What is changed?
The GMP requirements on the Class Ⅰ devices are abolished under the newly amended Notification. (Article 3, Article 4(2) (b), Asterisk 1)
The Ministry believes that the newly amended regulations will benefit manufacturers/distributors by enabling them to save costs as well as to introduce products faster into the market.
3. Public Notice on Amendments to Notification on the GMP regulations.
The GMP regulations are amended as follows.
- Article 3(2) or “Class Ⅰ devices except those applicable to the Asterisk 2” are designated as the Class Ⅰ medical devices.
- Article 4(2) (b) is stroke out.
- Asterisk 1 is omitted.
* The Notification goes immediately into effect with the announcement.