NMPA Encouraging Enterprises To Lead Standard Drafting


2022-12-28

According to the work deployment of the NMPA, the Center for Medical Device Standardization Administration NMPA has drafted the “Enterprise Led Drafting of Recommended Industry Standards for Medical Devices (Trial)” under the framework of the “Medical Device Standardization and Revision Management” to regulate the drafting of recommended industry standards for medical devices by enterprises. With the approval of the NMPA, the draft for comment is now available for public comment as required.

This is the description of the new and old standard system given by the National Standards Commission when the group standard came out in 2018, that is, the recommended industry standard should be dominated by the government. Therefore, the “Enterprise Led Drafting of Recommended Industry Standards for Medical Devices (Trial)” drafted by the Standardization Administration is a good opportunity. At the same time, it fully reflects the standard under the supply-side structural reform from government-led to government-guided. What is foreseeable in the future is the emergence of a large number of projects, everything is the best arrangement. 

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