South Korea - Proposition of Amendments to the “Regulation on In Vitro Diagnostic Medical Device Group and Class by Group”

Business description

The Ministry of Food and Drug Safety (MFDS) is amending the “Regulation on In Vitro Diagnostic Medical Device Group and Class by Group” as follows:

1) Establishment of new product categories for in vitro diagnostic (IVD) medical devices for self-testing, used for detecting influenza virus, sexually transmitted infections and drugs of abuse.

2) Reclassification of IVD reagents for the self-testing of SARS-CoV-2 antigens and antibodies, from an intermediate category (K05000) to a subcategory (K0570.01).

Source: G/TBT/N/KOR/1346

Countries:

South Korea

Product categories:

Medical Devices

Technical aspects:

Safety

Business fields:

P.05 Medical

Regions:

Asia

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