Home About Qualtech NEWS CHINA: NMPA to Single Out Foreign Manufacturers of Medical Products with Dubious Quality Systems – January 2019
CHINA: NMPA to Single Out Foreign Manufacturers of Medical Products with Dubious Quality Systems – January 2019

January 15, 2019

In order to ensure that all imported medical products (including medicines and medical devices) entering China’s borders keep up with the national quality standards, NMPA has passed on the “Regulations on the Administration of Overseas Inspection of Medicine and Medical Devices” which waseffective last December 2018.

All manufacturers of medical products that meet any of the following conditions shall be closely monitored by the NMPA and shall be included in their priority lists for on-site inspections:

(1) Manufacturers of products with potential risks found during evaluation period;

(2) Manufacturers of products with inspection or batch certificates not complying with the current regulations, which is a clear indication of a faulty quality management system;

(3) Manufacturers of products with adverse reactions or adverse events found during monitoring, suggesting that there may be safety risks associated with the device’s use;

(4) Complaints or other evidences suggesting that violations of laws and regulations do exist;

(5) The registrant of the medical product previously had a bad record/s (in NMPA database);

(6) The results of on-site inspection/audits conducted by overseas regulatory agencies show that the quality management system of registrant has major problems;

(7) Necessities to carry out another inspection following rectification;

(8) Other situations in which overseas inspections are required.

NMPA has been conducting a number of domestic on-site inspections for several years, and now they are planning to cover supervision of overseas manufacturers to ensure that the manufacturing facilities in both domestic and foreign registrants comply with up-to-date quality standards. It is foreseeable that NMPA will be re-organizing the regulatory scope of medical device, and would focus not only in the registration stages, but also with the post market and overseas manufacturing supervision to guarantee quality, safety and effectiveness all throughout the lifecycle stages of the medical products marketed in China.

 

Reference:

Official press

 

 

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Home About Qualtech NEWS CHINA: NMPA to Single Out Foreign Manufacturers of Medical Products with Dubious Quality Systems – January 2019