Home About Qualtech NEWS CHINA: NMPA Director Discloses Important Updates on Currently Revamped Medical Device Regulations – August 2019
CHINA: NMPA Director Discloses Important Updates on Currently Revamped Medical Device Regulations – August 2019

August 13, 2019

China Pharmaceutical Innovation and Development Conference was held last July 16 and was attended by several manufacturing companies. Among the important guests of the said event was the Director of China NMPA, Ms. Jiao, who has delivered an informative speech that covers salient information on imported medical devices. Details of the speech are hereby summarized:

Improve the Regulatory System 

Revisions of the current regulation on the Supervision and Management of Medical Devices is expected to be drafted and released this year. Changes will include the following:

(1)  Definitions;

(2)  Rights and obligations of medical device license holders;

(3)  Requirements to establish an adverse event surveillance system and to submit self-examination report to NMPA are mandatory for all license holders in order to carry out re-evaluation of registered medical devices;

(4)  License holders may authorize other companies to produce theproducts;

(5)  Specific regulations for license holders of imported medical devices shall be issued;

(6)  Clinical evaluations for Class III medical devices are mandatory, whereas for Class II medical devices, this requirement won’t generally be compulsory unless deemed necessary.

2. Deepen the Reform of the Review and Approval System

Evaluations for Class II Medical Devices Registration applications shall be handled by either the NMPA main, or a third-party company duly authorized by NMPA. Test reports for Class II and Class III medical devices shall be completed by the applicant or any qualified medical device testing centers. Registrations for imported innovative medical devices that are not listed domestically or from foreign countries will no longer require the free sale certificate. 

3. Strengthen Post-marketing Surveillance

NMPA will be appointing a team in charge of medical device inspections to improve the overall inspection and re-inspection system. NMPA shall penalize a natural (rather than a juridical) person and additional penalty fee shall be imposed for any intentional violations.

Qualtech has only assisted in translating the summary of the speech. Hence, the content of this article does not fully reflect the succeeding revisions to be made by the NMPA.

  

Reference:

Official press

 

Tags:

Main regulation update, Supervision and Management

 

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Home About Qualtech NEWS CHINA: NMPA Director Discloses Important Updates on Currently Revamped Medical Device Regulations – August 2019