The Medical Device Technical Evaluation Center combined the characteristics and status quo of registered submissions of medical devices inside and outside China, summarized the actual conditions of technical evaluation, referred to relevant documents, and then organized experts from multiple fields to jointly work out the Guiding Principles on Registration Submission Technology Examination of Hemoconcentrator (Draft for Comment).
To make the guiding principle more scientific and reasonable, public opinions will be sought online from now on. We sincerely hope that experts, scholars, managers and employees of relevant fields can actively participate and put forward constructive opinions and suggestions to enrich and improve the guiding principles and promote the improvement of the quality and efficiency of medical device research and development and technical evaluation.Please email your feedback to the Center before June 12, 2016.
Contact: Luo Qingfeng
Tel: 010-86452840E-mail: luoqf@cmde.org.cn
Fax: 010-86452859
Address for Correspondence: Medical Device Technical Evaluation Center, China Food and Drug Administration, 55 Xiwai Taipingzhuang, Haidian District, Beijing
Postcode: 100081
Attachment:
1. Guiding Principles on Registration Submission Technology Examination of Hemoconcentrator (Draft for Comment)2. Guiding Principles on Registration Submission Technology Examination of Hemoconcentrator (Draft for Comment) Feedback Form
Center for Medical Device Evaluation, China Food and Drug Administration
June 13, 2017