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.
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