China FDA Updates Medical Device Recall Process
EMERGO SUMMARY OF KEY POINTS:
- The China Food and Drug Administration (CFDA) has replaced a pilot medical device recall system with a permanent process, Order No. 29.
- The definition of “defective medical device” has been expanded under the new recall program.
- The new program will go into effect May 1, 2017.
Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective devices.
The new provision, CFDA Order No. 29, replaces a pilot recall provision (Order 82) that had been in place since 2011, and expands the CFDA’s definition of “defective medical device” to include products that:
- Pose unreasonable risk to health when used under normal conditions
- Do not complly with Chinese mandatory standards or approved product technical requirements
- Pose unreasonable risks due to non-compliance with production and distribution requirements.
The new order keeps in place a three-level recall process featured in the pilot program. Following a written notification to initiate a device recall, a foreign manufacturer’s China agent must develop a recall plan, an investigation report and proper recall report forms. Information that these forms must provide to the CFDA include number of people or entitities notified of the recall, means of notification and quantity of devices recalled.
The new recall system comes into force May 1, 2017.