The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning Commission) released in 2011 (Current Rules).  Comments on the Proposed Rules are due on September 30, 2016.

The Proposed Rules’ revisions appear to be primarily directed at aligning current recall standards with the new provisions on recall in the revised framework regulation for medical devices—the Medical Device Supervision and Administration Regulation (MDSAR), which was issued by the State Council in 2014 (see our alert, here).  Under the MDSAR, the standard for recall turns on whether the device is “defective,” an undefined term.  MDSAR also increased penalties for medical device manufacturers and distributors that fail to recall defective products.

The Proposed Rules, if finalized, would direct the following key changes:

  • Expand the scope of products subject to recall. The Current Rules require manufacturers to recall medical devices that present an unreasonable risk of harm to human health and life safety in the course of normal use. The Proposed Rules would require a recall for (1) any medical device that is not in compliance with mandatory standards or the products’ “technical requirements” that are filed as part of its premarket approval application, (2) devices that present an unreasonable risk because of noncompliance with good manufacturing or supply practices, and (3) other products that CFDA determines must be recalled.
  • Expand the obligation of medical device distributors and user entities (i.e., hospitals and other clinics) to report on defective devices. Whereas the Current Rules require an established defect to trigger a reporting obligation, the Proposed Rules require a report if there is a possible defect.
  • Increase penalties for noncompliance. The Proposed Rules would increase the maximum penalty for failure to recall a device subject to a mandatory recall order from CFDA or a provincial food and drug regulatory authority from three times the value of the medical device to ten times its value. For medical device distributors and user entities, the Proposed Rules would increase the minimum penalty for failure to report and to suspend distribution and/or use after discovering a defect from RMB 1,000 to RMB 5,000. Also, the local food and drug administrations would be granted the authority to suspend the sale, use and manufacture of defective products.

Domestic and foreign medical device companies doing business in China should consider submitting comments on the Proposed Rules and should monitor updates for the final version.