Recently, NMPA has formulated basic principles to evaluate the safety and performance of medical devices (hereinafter referred to as "principles").
- The first part of the principles is the general set of principles applicable to all medical device.
- The second part refers to special set of principles applied for non-diagnostic and diagnostic medical devices.
The principles covers stability requirements of each product throughout their lifecycle, their design requirements to avoid the contamination risks, requirements for combination use with other medical devices, dose control, special requirements for implantable medical devices. Moreover, NMPA has also clarified definitions of some supplementary terminologies.
As there are a variety of medical devices, manufacturers shall consider the product characteristics according to the "Basic Principles", to clarify the specified performance in product design and production. Moreover, manufacturers shall also identify related risks and take corresponding measures to control them. Construction of quality system files and technical documentation files should also be referred to these "Basic Principles".