Medical Devices

Proposed amendments to the "Enforcement Rule of the Medical Devices Act"; (16 page(s), in Korean)

The Proposed amendments to the "Enforcement Rule of the Medical Devices Act" are as follows:

1) Establishment of fees for newly developed medical device approval and/or preliminary review

- New fees for applications for manufacturing and/or import approval of newly developed medical devices and preliminary review of technical documents, etc.

2) Establishment of fee reduction provisions for newly developed medical devices

- Exemption of fees for manufacturing and/or import approval (including the review of technical documents) if a preliminary review application for a newly developed medical device is deemed compliant

- Establishment of a legal basis for reducing or exempting fees if a small and medium-sized enterprise applies for manufacturing approval (or preliminary review) of newly developed medical devices

3) Establishment of a legal basis for exemption from redundant submission of medical device quality managers' qualification proof documents

- Provision to prevent the repeated submission of qualification verification documents for quality managers in case of their changing employment, provided their qualifications have already been verified