EMERGO SUMMARY OF KEY POINTS:

• Chinese regulators have published required forms for use by manufacturers and registrants in medical device recalls.
• The forms help clarify China Food and Drug Administration (CFDA) device recall policies and requirements.

Chinese medical device market regulators have made reporting forms necessary for recall management available online.

As part of an effort to clarify device recall requirements in China, the China Food and Drug Administration (CFDA) published (link in Chinese) two form templates for use by manufacturers whose products must undergo recalls: the Medical Device Recall Report Form and the Medical Device Recall Implementation Status Report Form.

How CFDA registrants should use device recall forms

In the event that a CFDA registrant must initiate a device recall, the firm should submit a Medical Device Recall Report Form to the CFDA as soon as possible, and then follow up with an evaluation report and recall plan within five working days. During the course of a recall, the registrant should submit Medical Device Recall Implementation Status Report Forms based on their recall plans.

Foreign manufacturers are also required to submit Medical Device Recall Report Forms to the CFDA even if their recalls do not affect their devices sold in China.

The CFDA publishes recall data from registrants on its website.

Emergo services and support for the Chinese market

• CFDA registration support for medical device companies
• China medical device regulatory strategy report
• Video overview: China medical device registration
• Chinese medical device regulatory process chart