In December 2014 the China Food and Drug Administration (CFDA) revised the existing provisional good manufacturing practices (GMP) for medical devices and issued the country's first good supply practices (GSP) for medical devices. The new GMP rules became effective on March 1 2015, while the GSP rules came into effect immediately on December 12 2014. These rules serve as minimum standards for the quality management systems of device manufacturing and distribution in China. They form an important part of China's new device regulatory regime, which has been substantially transformed since the promulgation of the Regulation for the Supervision and Administration of Medical Devices (State Council Order 650) on June 1 2014.
The new rules adopt three guiding principles: end-to-end risk management, traceability and detailed requirements for workshops and equipment.
End-to-end risk management
The new GMP rules require legal manufacturers to manage risks throughout the entire product life cycle (ie, from product design and development, manufacturing and sales to after-sale services). Likewise, the GSP rules require distributors to manage risks throughout the entire supply chain (ie, from procurement, delivery acceptance, storage, sales and transport to after-sale services). The design and implementation of the quality management system should reflect products' risk profiles. For example, distributors of Class 3 devices must build an IT infrastructure to enable sound implementation of the quality management system, whereas distributors of Class 1 and 2 devices are not subject to the same obligation.
The new GMP and GSP rules also introduce several new requirements to avoid adverse effects on product quality in each product transfer. Manufacturers and distributors must qualify and audit their upstream suppliers and enter into quality agreements with these suppliers. Manufacturers should also promptly inform users or consumers of any product changes or updates.
The new GMP and GSP rules require manufacturers and distributors to retain complete documentation throughout the product lifecycle and supply chain to ensure traceability. The documentation includes records for product design and development, production records, testing records, purchasing records, sales records and after-sale services records. Records relating to delivery acceptance and sales of implants must be retained permanently.
Detailed requirements for workshops and equipment
The new GMP rules enhance standards for the manufacturing environment, which must be fit for production and must not adversely affect product quality. Manufacturers must maintain appropriate production, testing and warehousing space. They must fit workshops with the necessary production, testing and measuring equipment based on product attributes and manufacturing needs. Manufacturers must follow protocols for the operation, cleaning and maintenance of the manufacturing equipment, which must be evidenced in relevant records.
The CFDA expects all device companies to comply with the new GMP and GSP rules as long as they intend to sell products in China. The CFDA, like its foreign counterparts, plans to exercise its jurisdiction over foreign legal manufacturers and may arrange overseas GMP inspections in the future. Companies that plan to introduce their devices to China are recommended to carefully review the new GMP and GSP rules and swiftly address any potential discrepancy in their operations.
For further information on this topic please contact Katherine Wang at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (email@example.com). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.
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