The China Food and Drug Administration (“CFDA”) published a draft of its first nationwide Good Supply Practice for Medical Devices (the draft “GSP”), which regulates medical device distributors and third-party logistics providers in China.
Making reference to international standards such as ISO 13485:2003 and ISO 9001, the draft GSP requires distributors and logistics service providers to set up appropriate quality management systems to ensure (1) proper control over the entire distribution chain; and (2) product traceability.
Depending on the safety profiles of medical devices in different classes, the draft GSP imposes specific record-keeping, warehousing facility and personnel obligations on distributors and logistics service providers. Highlights are:
- Companies must keep records of procurement, inspection, warehousing, sales, product returns, temperature monitoring, installation and inspection, quality and complaint handling activities for medical device products for at least 2 years. For wholesaling companies as well as those retailing Class III products, inspection and sales records must be kept for at least 2 years after expiration of shelf life, or no less than 5 years if the products have no shelf life. For implantable devices, the records must be kept permanently.
- Companies must establish appropriate warehousing facilities, particularly for those products that require cold chain storage and transportation. However, the draft GSP makes no requirement on the minimum warehousing space and allow exemptions from separate warehouse requirements for companies that
- only retail medical devices;
- have all of their products warehoused by third-party logistics providers;
- only distribute medical device software or large scale medical equipment such as X-Ray, MR, or PET devices.
- Companies must employ quality management personnel with an appropriate level of education. Personnel in key functions such as inspection must have professional licenses specific to the relevant device products. For companies distributing implantable devices, personnel must be trained by the manufacturer or upstream suppliers.
- Companies maintain their own personnel dedicated for after-sale services or outsource such services to third parties.
Because there was previously no nationwide GSP, provincial FDAs have established their own local rules regulating medical device distributors in their provinces, imposing requirements on, inter alia, minimum warehousing space, minimum number of management personnel etc. It remains to be seen how the provincial FDAs will reconcile their local requirements after the national GSP becomes effective. Companies are well advised now to re-examine their third-party supply arrangements and GSP practices as this regulation, once implemented, will be a game changer.