To all concerned:
IMDRF documents (Annex 1) including Clinical Evidence – Key Definitions and Concepts, Clinical Trial and Clinical Evaluation which were compiled under the organization of China's drug regulation authorities were approved unanimously at the 16th Management Committee meeting and officially issued.
Technical Guidelines for Clinical Evaluation of Medical Devices (Draft for Comments) (Annex 2) are developed from the equivalent transformation of Clinical Evidence – Key Definitions and Concepts, Clinical Evaluation and Clinical Trial, aim to fully utilize the evaluation principles, ideas and methods in IMDRF documents and speed up the scientization, internationalization and modernization in China's clinical evaluation requirements under the framework of Chinese laws and regulations. In the international convergence of clinical evaluation requirements, stakeholders can better evaluate the safety, clinical performance and/or effectiveness of products and more effectively utilize clinical, industrial and regulatory resources, and further enhance the regulatory transparency and confidence, and patients and society can procure new, safe and effective products in a more efficient and predicable manner.
Now the document is open to experts, scholars, enterprises, practitioners and other stakeholders in relevant fields for valuable comments and suggestions.
Annex: 1. IMDRF Documents on Clinical Evaluation (Download)
2. Technical Guidelines for Clinical Evaluation of Medical Devices (Draft for Comments) (Download)
3. Feedback Form of Technical Guidelines for Clinical Evaluation of Medical Devices (Draft for Comments) (Download)
National Medical Products Administration
Center for Medical Device Evaluation
January 2, 2020