China Establishes New Medical Device Recall Regulations

The China Food and Drug Administration (CFDA) recently adopted new regulations for medical device recall. The new rules expand the definition of defective products that require recall. Under the new regulations, devices that do not comply with compulsory standards or present an unreasonable risk due to noncompliance can be recalled. Additionally, the rules stipulate the CFDA can determine a medical device must be recalled for unspecified “other” reasons. The penalties for noncompliance have also increased to 5,000RMB (roughly $725 USD). The new rules will go into effect May 1, 2017.