South Korea amending regulations on approval, notification and review of the medical devices

Ministry of Food and Drug Safety seek to amend following changes;

1.      Clarify definition of single-use medical device

2.      Expand the scope of medical devices prohibited from authorization, certificate, and declaration. (to include powdered medical gloves)

3.      Amend the scope of minor changes: delete 1) amendment to the declared product and 2) change to the address of manufacturer (consignee)

4.      Expand the scope of medical devices subject to issuance of a certificate for confirmation of medical devices.

Products covered: Medical Devices             

HS Code: 9018, 9019, 9020, 9021, 9022, 9023, 9024, 9025

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.