CFDA Issued Priority Approval Opinion Draft on Medical Devices

  • 2016-06-30

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

To satisfy the clinical demands of medical device, in accordance with the provisions of Regulations on Supervision and Administration of Medical Devices (No. 650 of Decree of State Council), Opinion of State Council on Reformation of Examination and Approval System for Drug Medical Device (No. 44 [2015], State Council), Device Registration Department of CFDA organized and drafted Priority Approval Procedure for Medical Devices (see Annex for exposure draft). We appreciate your feedback before July 20, 2016 upon your study.

E-mail: Please indicate at “Subject” line the “opinion on priority approval procedure” when sending the email.

Letter: Device Registration Department of CFDA, Building 2, No. 26 Xuanwumen Xidajie, Xicheng District, Beijing, 100053

Any unit or person may send email or letter to above address for feedback, and the deadline for opinion seeking is the same with above.

Device Registration Department of China Food and Drug Administration

June 20, 2016