South Korea - Draft Amendments to the ​Enforcement Rules of the In Vitro Diagnostic Medical Devices Act.

The Ministry of Food and Drug Safety (MFDS) has announced draft amendments to the ​Enforcement Rules of the In Vitro Diagnostic Medical Devices Act.

This revision addresses performance evaluation criteria and methods, application procedures for performance evaluations, and the delegation of performance evaluation tasks. These changes are intended to ensure the proper enforcement of the Act and to regulate matters delegated by the law.

- Performance Evaluation Criteria and Methods (Article 38-2)

- Application Procedures for Performance Evaluations (Article 38-3)

- Delegation of Performance Evaluation Tasks (Article 38-5)