In December 2014, China's Food and Drug Administration ("CFDA") revised the existing provisional Good Manufacturing Practices for medical devices ("New GMP"), and issued the country's first Good Supply Practices for medical devices ("GSP"). The New GMP rules will become effective on March 1, 2015, and the GSP rules immediately came into effect as of 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 was substantially transformed since the promulgation of the Regulation for the Supervision and Administration of Medical Devices (also known as State Council Order No. 650) on June 1, 2014.
The New GMP and GSP rules adopt the following guiding principles:
- End-to-End Risk Management
The New GMP and GSP rules also introduce several new requirements to avoid adverse impacts on product quality in each of the product transfers. 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.
- Detailed Requirements for Workshops and Equipment
The CFDA expects all device companies to comply with the New GMP and GSP rules as long as they intend to sell the 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 the GSP rules and timely address any potential discrepancy in their operations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.