Home About Qualtech NEWS CHINA: Regulation of Customized Medical Device is Officially Released – August 2019
CHINA: Regulation of Customized Medical Device is Officially Released – August 2019

August 13, 2019

NMPA has officially released the "Regulation on Supervision and Management for Customized Medical Device" in July and will be implemented by January 1, 2020. The regulation clarifies the requirements for the definition, listing, design, processing, usage, supervision and management of customized medical devices.

Customized medical devices are devices that are produced according to suitable specifications based upon the the prescribed needs of a specific patient group as determined by the physician. These devices are specifically catered for rare conditions. Personalized medical devices are expected to improve the diagnostic performance and treatment efficacy.

The medical device manufacturers and the medical institution shall jointly act as license holders of customized devices. The regulation has set clear requirements in order to properly mitigate risks associated with the use of such devices.

Compared with the general medical device listing process, NMPA develops more stringent requirements based on the following points:

1.    Strict requirements have been placed on the qualifications of the license holder: 

Conditions are set for the manufacturer and medical institutions using customized medical devices.

2.    Put forward more detailed requirements for development stage: 

Requirements for a comprehensive design verification, risk management, and relevant records of design and production processes. Should changes have been made in the design, manufacturers are obliged to conduct verification procedures. Manufacturers should also inform physicians of these changes.

3.    The traceability management also puts forward clear requirements: 

The manufacturer shall assign a unique identification number for each customized medical device, and all relevant records should be kept for not less than the lifetime specified by the manufacturer. All records for customized implantable device shall be stored, and documentations for other non-implantable, customized medical devices shall be kept for at least 5 years from the date of release.

  

Reference:

Official press

 

Tags:

3D printing, Customized medical device

 

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Home About Qualtech NEWS CHINA: Regulation of Customized Medical Device is Officially Released – August 2019