China CMDE has issued 613 guidelines for medical device registration review

Release date:2024-01-09

The Guiding Principles for Medical Device Registration Review (hereinafter referred to as the Guiding Principles), as a new tool, method, and standard for medical device technical evaluation, play an important role in improving scientific evaluation capabilities and promoting the high-quality development of the industry. CMDE adheres to the principle of scientificity and constructs a guiding principle system that is suitable for the development of China’s medical device industry.

In recent years, the construction of the guiding principle system for medical devices in China has achieved significant results, with the quality and quantity of guiding principles significantly improved, and the structural layout of guiding principles continuously optimized. As of the end of 2023, the number of revisions to China’s guiding principles has reached 613, providing comprehensive and multi-dimensional guidance for registration application and technical evaluation. CMDE will continue to strive to enhance the scientific, forward-looking, and leading nature of its guiding principles. Building a solid foundation for evaluating scientific technical documents, thereby promoting the efficiency of medical device regulation, and further assisting and guiding the high-quality development of the medical device industry.