The China Food and Drug Administration (CFDA) issued a proposed Rule on Good Supply Practices for Medical Devices on December 26, 2013 (Proposed GSP Rule). The comment period closed on January 20, 2014.
Good Supply Practices (GSP) refer to a set of standards for quality management of the distribution process for drugs or medical devices. These standards have been adopted by regulatory agencies in many countries. GSP standards for drugs were adopted in China in 2000 and were revised last year. However, China has not yet adopted any GSP standards for medical devices. The lack of GSP standards for medical devices has caused problems in maintaining the quality of medical devices during the distribution process.
The Proposed GSP Rule sets out many requirements for quality management of medical device distribution. Some of the requirements proposed include:
Companies must appoint corporate officers to be primarily responsible for the overall quality of the company¨s distribution activities, but must also appoint specialized quality control personnel.
Companies must comply with qualification requirements for employees with key roles in quality management, inspections, and sales of implantable devices.
Companies are required to keep a complete and accurate record of procurement, inspection, storage, sales, inventory management, return and replacement, temperature and humidity, inspections, and disposal of nonconforming products for specific lengths of time depending on the device classifications.
Companies must have separate offices and warehouses that are suitable for their business scale and scope. Such companies may not place warehouses in residential buildings or military barracks. There is no national requirement for minimum square footage for offices or warehouses because local FDAs have already imposed various requirements in this regard.
Companies engaged in wholesaling of Class III devices are required to install a computer information system to serve the distribution business, whereas distributors of Class I and Class II devices are encouraged to set up such system.
The Proposed GSP Rule sets forth practice standards for 10 additional key steps of the distribution process: (1) procurement, (2) receiving, (3) inspection and acceptance, (4) stock in, (5) storage, (6) periodic checks, (7) sales, (8) stock out, (9) transportation, and (10) after-sale services.
The Proposed GSP Rule applies to traditional wholesale and retail sales, but does not apply to online sales. The biggest open question is enforcement. The Proposed GSP Rule itself does not specify how it will be enforced or what type of liabilities will be imposed if companies do not comply. Therefore, CFDA may have to issue a separate rule addressing how the GSPs will be enforced.
In sum, the Proposed GSP rule represents a significant change in the quality standards for medical device distribution. For this reason, Chinese and foreign companies that distribute medical devices in China should closely monitor the developments and be prepared to comply with the final rule.