To the food and drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government and related units,

According to the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices (Decree of the State Council, No. 680, “the Decision”), the clinical trial facilities of medical devices shall be subject to recordation management rather than qualification accreditation. For implementation, the Medical Device Registration Department of CFDA drafted the Measures for Conditions and Recordation Management of Clinical Trial Facilities of Medical Devices (Exposure Draft), now is soliciting opinions from the general public. We appreciate your opinions and suggestions feedback by August 25, 2017 upon your study.

The food and drug administration of all provinces, autonomous regions, and municipalities directly under the Central Government shall collect the opinions of medical institutions and relevant enterprises within the jurisdiction and feed back the writing and electronic opinions to us. Other units or persons can email or fax their opinions feedback.

Contact: Cheng Jin, Wang Xiaoguang

Tel.: 010-88331453, 88331463

Fax: 010-88331443

E-mail: mdct @cfda.gov.cn

Attachment: Measures for Conditions and Recordation Management of Clinical Trial Facilities of Medical Devices (Exposure Draft)

Device Registration Department of China Food and Drug Administration

August 4, 2017