South Korea - Proposed Establishment of the “Standards of Digital Medical Devices Good Manufacturing Practices"

​The Ministry of Food and Drug Safety (MFDS) intends to establish the Standards of Digital Medical Devices Good Manufacturing Practices including the following:

1) Definitions of terms used in the Regulations

2) Targets for conformity assessment

3) Types of conformity assessment

4) Criteria for conformity assessment

5) Methods of  conformity assessment

6) Application for conformity assessment

7) Procedures for conformity assessment

8) Validity period of the certificate of conformity assessment

9) Reissuance and return of the certificate of conformity assessment

10) Indication of conformity assessment

11) Responsibilities and reporting of agencies delegated with certification tasks