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