South Korea - Proposed Amendments to the "Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices"

Business description

South Korea Ministry of Food and Drug Safety is proposing to amend the "Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices" as follows:

A. Enable the elimination of the manufacturer's address on the outer packaging of small size In Vitro Diagnostic Medical Devices.

B. Enable the elimination of duplicate information written on both the outer packaging and attached documents of In Vitro Diagnostic Medical Devices.

C. Simplified the submission data required for the application of Clinical Performance Study Plan approval of low-risk In Vitro Diagnostic Medical Devices.

Proposed date of adoption : To be determined

Proposed date of entry into force : To be determined

Final date for comments : October 4, 2022

Source: G/TBT/N/KOR/1092

Countries:

South Korea

Technical aspects:

Labeling and Packaging

Safety

Business fields:

P.05 Medical

Regions:

Asia

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