China: Raw Material Changes, Human Factor Design and eRPS management system

Guidance document for Evaluation of Raw Material Changes in Passive Medical Devices

Throughout the life cycle of a medical device, changes to raw materials, production process, inspection procedures, production equipment, et cetera may be implemented to improve product quality, supply chain management or to meet updated regulations and standards. Change control of raw materials of medical devices is crucial in maintaining its safety and effectiveness. The National Medical Products Administration has released a guidance document for risk analysis of raw material changes in passive medical devices.

Source: CMDE


Guidance document draft for technical review of medical device human factor design

Application of human factors/usability engineering in the design of medical devices helps ensure safe and effective use of medical devices during normal intended use situations. Additionally, foreseeable risks arising from incorrect use or misuse can be mitigated. The National Medical Products Administration is soliciting comments for a draft of a guidance document for human factor design in medical devices.

Source: CMDE


Update to electronic medical device registration management (eRPS) system

Updates to the electronic medical device registration management (eRPS) system has been made to improve the the convenience of registration and declaration, and to facilitate applicants/registrants to use the eRPS system for electronic declaration. An extension of one year can be made to the validity period of the CA certificate can be extended by one year through online operations without changing the certificate information and functions.


Source: CMDE

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