The CFDA has released the Administrative Measures for Medical Device Recalls (The “Measures”), which will take effect on May 1^st, 2017. The Measures specifically define the scope of defective medical devices and the parties responsible for recalls.

  The Measures include the following features:

1. Identifying the parties responsible for medical device recalls;

2. Defining the scope of defective medical devices;

3. Redefining the scope of defective medical devices;

4. Adding defect assessment methods;

5. Changing the regulatory authority responsible for the destruction of recalled products;

6. Tightening the requirements on information disclosure regarding recalls; and

7. Further strengthening the regulatory authority of the CFDA.

  The Measures also specify that medical device manufacturers should establish and improve the management of medical device recalls, strengthen the obligations of manufacturers of medical devices to report on recalls, and improve the requirements for notifying the CFDA.

  From: The P.R.C. Food and Drug Administration