Beijing, March 19(Xinhua)--Chinese Premier Li Keqiang signed an order of the State Council, issuing the newly revised Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to as Regulation). This document will enter into effect on 1 June, 2021.
Regulation implements the system of medical device registration applicants and the filing applicants and strengthens the main responsibility of enterprises. It stipulates that reistration applicants and the filing applicants shall establish and effectively operate the quality management system, strengthen the post-market management of the products, and establish and implement the trace and recall system of products, to undertake the due obligations for the safety and effectiveness of the medical device during the whole process of development, production, operation, and use.
Regulation implements the reforms to streamline administration and delegate power, improve regulation, and upgrade services and encourages innovation and development of the industry. It recognizes the innovation of medical devices as the focus of the development, improves the examination and approval procedures and filling procedure, implements the implied license for clinical trials, shortens the review duration and implements informative record.
Regulation improves the supervision system to enhance the efficiency of supervision. It states that it’s necessary to strengthen the construction of supervision team, establish a professional inspector system, enrich the means of supervision, further clarify responsibilities of different departments, and strengthen the supervision and inspection of the use of medical devices.
Regulation enhances the punishment for illegal acts. It meets the requirement of the punishment for persons making illegal acts, intensifies the punishment of banning illegal units into the industry and market and levies more fines for illegal entities.
To get the full text in English of this Regulation, please contact assistant@bestao-consulting.com