Medical device supplier directive published by CFDA
The China Food and Drug Administration has published a draft regulation, GOOD SUPPLY PRACTICES FOR MEDICAL DEVICES, for comment in late 2013. It sets out minimum standards for device distribution, procurement, delivery acceptance, storage, sales, transportation, and after-sales service. Opportunity for comment expires on January 20 and it is expected to come into force shortly.
It applies to all Class 1, 2 and 3 medical device distributors, and third party logistics service providers. The regulation includes directions on:
-
Quality management
-
Qualification and training requirements
-
Warehousing (varies by province)
-
Cold storage and refrigerated transportation
-
Retail presentation of medical devices
-
Computerised management systems
-
Supplier management
-
Record management systems
-
Procurement, delivery, and sale processes
-
After-sales services.
Class 3 device wholesalers and retailers must maintain delivery acceptance records and sales records for a period of at least two years after the expiration date of the medical device. In the case of implants it is perpetual. They must also establish an IT system to retain records of product batch or serial numbers to enable origin tracing.
Separate rules to regulate supply practices of online medical device distribution are expected later.