Jul 12, 2012

Recently, China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls. The legal document China Provisions on Medical Devices Recalls (interim) came into force on July 11, 2011.

From the SFDA Provision, a recall is defined as:

(...) a warning about, examining, repairing, re-labelling, revising or improving the specifications of, upgrading software for, replacing, recalling or destroying a certain category, type or batch of sold defective products in accordance with the procedures provided to eliminate the defect.

In turn, a defect is defined as “any unreasonable risk caused by a medical device in normal use that may endanger human health or safety”. According to the Provisions, the medical device manufacturer is accountable for product defects and device safety. However, in the case of foreign manufacturers, the legal agent remains responsible for the recall process.

No guidance has been published that suggests how the Provisions will be implemented. Nevertheless, Chinese recalls are divided into three classes depending on the severity of health damages. The most serious type of recall, Class I (causing “serious health damages”), must be notified to the SFDA within one day. Class II and Class III recalls (“reversible” or “minor” health damages) must be notified within three and seven days respectively.

Article 8 of the Provisions state that the drug regulatory authority of the province, autonomous region or municipality directly under the central government where the designated legal agent is headquartered shall be responsible for the supervision and management of medical device recalls. Non-compliance may lead to heavy fines and a cancellation of manufacturer’s license to sell their medical devices in China.

A written notification is required to perform a recall. This notification is subsequently followed by a recall plan, an investigation report, and proper recall report forms within five additional days. Requested forms are provided as annexes to the Provisions and are titled Report of Medical Device Recall Event and Report on the Implementation of the Recall Plan. Among other things, these forms detail: number of persons notified, the means of notification, and the quantity of products recalled. Recalls of devices performed by a foreign manufacturer outside China shall also be notified to the SFDA when the product in question is marketed in China.

The designated legal agent is responsible to perform the recall and to fulfill related obligations on behalf of foreign manufacturers. Likewise, notifications of foreign recalls (for devices marketed in China) are also performed by the legal agent.


  • Stewart Eisenhart