China, NMPA announces the publication of this guidance document to further strengthen the administration and supervision on medical device registration, as well as to improve the efficiency and quality of administrative procedures.
This guidance establishes requirements for product design and manufacturing, which are defined as “essential principles of safety and performance” and intended to give instructions to medical device manufacturers on product development and manufacturing.
The guidance is structured in two parts:
- (Part I) General principles for all medical devices.
- (Part II) Specific principles that apply to non-diagnostic devices and in-vitro diagnostic devices (including combination products).
The activities of design and production by manufacturers should be conducted under the control of QMS.
Manufacturers are required to provide justification for compliance with these essential principles, which will then be evaluated by the supervision authority.
Link to source: https://www.cmde.org.cn/CL0058/20607.html