On September 27, 2021, the NMPA (National Medical Products Administration) published the technical guidelines for clinical trials of in vitro diagnostic reagents, and the following two parts of the technical review guidelines for animal testing on medical devices:
- Part I: Decision Principles (2021 amendment)
- Part II: Design of animal testing and implementation of quality assurance
On September 28, 2021, the NMPA issued the following 5 regulatory guidelines:
- Technical guidelines for clinical evaluation on medical devices.
- Technical guidelines for deciding whether to carry out clinical trials on medical devices.
- Technical guidelines for clinical evaluation of medical devices.
- Technical guidelines for registration and application of clinical evaluation reports of medical devices.
- Technical guidelines for comparison of products included in the list of medical devices exempt from clinical evaluation.
The technical guidelines for clinical evaluation of medical devices redefines clinical evaluation as an ongoing activity which requires periodic reviews to be conducted and clinical evidence to be updated throughout the product’s lifecycle. In the past, clinical evaluation was considered important to applicants for pre-market registration, however, pre-market clinical evaluation is no longer sufficient for the NMPA to fully evaluate the safety and efficacy claims of the product whilst some adverse events could rarely be detected in pre-registration studies. Many medical devices require post-marketing clinical data to carry out product upgrades. Special attention on design features or target user groups is required for clinical evaluation whilst the scope is based on the risk management documents.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.