Medical devices

Amendments to the Standards of Medical Device Good Manufacturing Practices; (11 page(s), in English)

The proposed amendment to the Standards of Medical Device Good Manufacturing Practices is as follows:

1) Re-classification of medical device product group

2) Modification of required dossier for documentation review

3) Complete transfer of KGMP audit authority to Korean private conformity assessment bodies for export-only medical devices

4) Clarification of combination medical devices that are subject to KGMP audit

5) Clarification of the KGMP audit procedure