Revision of the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act

In Vitro Diagnostic Medical Device (IVD)

In Vitro Diagnostic Medical Device Regulation (IVDR)

In vitro diagnostic medical device manufacturers and importers who fail to comply with corrective orders will be subject to administrative sanctions, including

- 1st violation: Business suspension for 1 month
- 2nd violation: Business suspension for 3 months
- 3rd violation: Business suspension for 6 months
- 4th or more violations: License revocation

This rule will take effect on April 26, 2024.

 

Medical Devices | MFDS

 

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