"Regulation on Approval, Notification and Review of the Medical Devices" is to be amended to include the 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 certificate for confirmation of medical devices.