January 15, 2018

In order to enhance the inspection of imported drugs and medical devices, China Food and Drug Administration (CFDA) has issued “Draft of Regulations for The Administration of Overseas Inspection of Drug and Medical Devices”. It is currently looking for public comments until January 24, 2018.

Imported medical devices listed in China or the drugs and medical devices that are expected to be listed in China are applicable to the provisions. The scope of provision is the inspection of overseas research, development, manufacture and production of drugs and medical devices.            

The relevant unit in CFDA would select the products that need to be checked through risk assessment of the product and random sampling. After approved by CFDA, the manufactures would receive the notification from CFDA, and the basic information of inspection plan would be announced.           

The flow chart of inspection:

1. The verification center (under CFDA) would send the importer “Letter of Notification of The Overseas Inspection of Drugs And Medical Devices”.
2. Importers should submit "Basic Information of The Overseas Inspection of Drugs And Medical Devices" within 20 working days after receiving the letter, and submit relevant production documentations in accordance with the site master file (SMF) within 40 working days for inspection.

The conclusion of inspection is divided into "Pass", "Undergo corrective action" and "Fail". Importers should submit the report of the corrective actions to the verification center within 40 working days after receiving "The Defect Report of Oversea Inspection for Drugs and Medical Devices" from CFDA, if the importers cannot submit it on time, then they shall submit to the progress of CAPA and detailed follow-up plan, and updates regularly until full implementation of the rectification.

Reference:

The draft of The Regulations for The Administration of Overseas Inspection of Drug and Medical Devices