Regulation on the Supervision and Administration of Medical Devices (2021 Revision) will be implemented on June 1 2021
On Feb 2nd of 2021, State Council of the People's Republic of China published order No. 739 for the issuing of Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to as “the Regulation”) (2021 Revision). The new 2021 revision will come into force on June 1st of 2021.
Regulation on the Supervision and Administration of Medical Devices is firstly published on Jan 4th of 2000 by the State Council in the purpose of ensuring the safety and effectiveness of medical devices, guaranteeing human health and life safety and promoting the development of the medical device industry. The Regulation has served in a role as the Constitution in this industrial sector and clearly defines, specifies and clarifies the supervision and administration measures and requirements on medical devices.
The latest 2021 version is revised under the facts that the medical device industry has been fast developing over the past years, and the variety, the category as well as the quantity of this sector have expanded in a vast change since the last version of the Regulation was issued 6 years ago.
In the 2021 revision of the Regulation, most of the new articles or contents are closely connected to some supporting policies that has been published in recent years for this field, and the main changes after comparing the previous version with this latest one, are basically in the following 4 factors:
1. It outlines more policy and principle on innovation in the medical device sector to encourage units and people to put more efforts into research and development, and innovation.
2. The new revision contains more reforming measures to stimulate R&D and to shorten evaluation/approval timeline. For example, it encourages hospitals to implement clinical tests on medical devices, and has includes such testing capability as one of the grade evaluation factor for the hospitals.
3. Regarding inspection, the new Regulation revision has simplify the inspection requirements on Class II and Class III devices. It entrusts industrial enterprises as first responsible person in this specific field, especially those with self-constructed labs, and has made it possible for companies with required conditions to accelerate the market-entry process of relevant devices.
4. It implements the strongest supervision and administration measures in this revision comparing with previous versions of the Regulation. The country will establish professional inspector system to enforce supervision on medical devices. The punishment for intentional law violation will be more severe, and specific punishment provision on individuals have been added as well.
The revision of the Regulation shows the determination of China for building up an innovation-driven market for medical devices with more open and scientifically oriented direction.
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