Notice on Public Solicitation of Opinions on 3 Medical Device Registration Review Guidelines including “Guidelines for Clinical Evaluation and Review of the Same Type of Absorbable Surgical Sutures (Draft for Comment)”

According to the relevant requirements of the State Drug Administration’s 2022 medical device registration review guidelines formulation and revision plan, the Center for Device Evaluation organized the compilation of 3 medical device registration reviews including the “Guidelines for the Clinical Evaluation and Registration Review of Absorbable Surgical Sutures of the Same Variety” The Guiding Principles have been researched and discussed, and a draft for comments (Appendix 1-3) has been formed, which will be open for comments online from now on.

If you have comments and suggestions, please fill out the feedback form (Appendix 4) and send it to the corresponding contact person of the Center for Device Evaluation by email before July 19, 2023. Please use the format of “Guidelines for XX Registration Review (Draft for Comment)” Feedback + Feedback Company Name” for the email subject and file name.

Contact and method:

1. Guiding principles for the clinical evaluation registration review of the same variety of absorbable surgical sutures (draft for comments)

Contact: Meng Ying

Tel: 010-86452504

E-mail: mengying@cmde.org.cn

2. Guiding principles for registration review of clinical evaluation of medical devices with artificial intelligence-assisted detection (draft for comments)

Contact: Wang Zehua

Tel: 010-86452521

E-mail: wangzh@cmde.org.cn

3. Guiding Principles for Registration and Review of Clinical Evaluation of Disposable Hemodialyzers (Draft for Comment)

Contact: Qiu Hong

Tel: 010-86452505

E-mail: qiuhong@cmde.org.cn