IGMPI India



New Medical Device GMP and GSP rules introduced by China

China's Food and Drug Administration ("CFDA") revised the existing provisional Good Manufacturing Practices for medical devices ("New GMP") in December 2014 and issued the country's first Good Supply Practices for medical devices ("GSP"). The new GMP rules will come into effect on March 2015 and the GSP rules came into effect on 12 December 2014.

The new GMP and GSP rules serve as an important part of China's new device regulatory regime and Quality Management Systems of device manufacturing and distribution in China. Companies that plan to introduce their devices to China have been recommended to carefully review the New GMP and the GSP rules and timely address any potential discrepancy in their operations as CFDA expects all the device companies to comply with these rules if they are want to sell their products in China

The principles laid down according to new GMP and GSP rules are as mentioned below:

End-to-End Risk Management

According to the new GMP rules, risks are to be managed throughout the product life cycle starting from product design, development to manufacturing, sales and after sales services

The GSP rules require distributors to manage risks throughout the entire supply chain starting from procurement, delivery acceptance , storage to sales and transportation to after sales services

Product's risk profiles should be a part of Quality management system which should reflect in its designing and implementation. For eg. 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

Manufacturers and distributors must qualify and audit their upstream suppliers

Quality agreements should be in place between manufacturers and distributors and suppliers

Manufacturers should also promptly inform users or consumers of any product changes or updates

Traceability

manufacturers and distributors are required to retain complete documentation which includes records for product design and development, production records, testing records, purchasing records, sales records, and after-sale services records throughout the product life cycle and supply chain to ensure traceability

Records relating to delivery acceptance and sales of implants must be retained permanently

Detailed Requirements for Workshops and Equipment

Manufacturers must maintain appropriate production, testing, and warehousing space

Workshops with the necessary production, testing, and measuring equipment based on product attributes and manufacturing needs must be fitted

Manufacturers need to follow protocols for the operation, cleaning, and maintenance of the manufacturing equipment, which must be evidenced in relevant records