NMPA: Such Medical Software must be Included in the Management of Class III Devices!

On June 9, 2021, the Medical Device Standards Management Center (NMPA) issued a notice to the industry on soliciting opinions on the Guiding Principles for Classification and Definition of Medical Decision-assisted Software (Draft for Soliciting Opinions).

The purpose of the notice is to guide the determination of the management attributes and management categories of medical decision-assisted  software products.

The “Principles ”mentions that the attributes of software products should be defined in combination with their processing objects, core functions and other factors, and based on their intended use, so as to make comprehensive judgments.

The “Principles” also clarified that the processing objects of decision-assisted software products included in the management of medical devices must be data generated by medical devices or general equipment for medical purposes (ie objective medical data);The software products whose processing objects do not contain objective medical data are not managed as medical devices.

In terms of management category, medical decision-assisted software which can be used as medical device management should be included in the third category of medical device management.

If you would like a full version of the guiding principles, or if you would like to make your own comments, please contact us  info@inspirativemed.com