The Medical Device Industry Supports Increased Regulatory Efficiency Go back »
2021-03-30 | All chapters
The Regulation on the Supervision and Administration of Medical Devices (the Regulation) is the highest-level legislative document on medical device registration and market supervision in China. The first version was promulgated in early 2000. After a major revision in 2014, the State Council passed the second amendment in December 2020, and officially published on 18th March. The new version of the Regulation will come into force on 1st June 2021.
Market supervision by regulatory authorities needs to balance patient’s safety and the need for quick access to affordable new and innovative medical devices.
On 23rd March, one week after its promulgation, senior representatives of the Healthcare Equipment Working Group, COCIR China and the Consumable and Disposable Medical Device Advisory Committee of the Chamber held a joint internal workshop to analyse the amended Regulation. The European medical device industry is glad to see that the new Regulation has adopted important proposals made by the industry. The improvements include, among many others:
- improving clinical evaluation system for medical devices (one of the core contents in the new Regulation);
- promulgating regulations to be used for emergency/management of importing small amounts of medical devices for clinical-urgent-need purpose (to cope with major public health emergencies and satisfy demand for clinical medical devices); and
- accepting manufacturers’ in-house type-test reports (pre-market requirement breakthrough).
Details of further medical device regulation will be specified in secondary regulatory documents that will be finalised in the near future. The Chamber will continue to cooperate with the National Medical Product Administration, by offering expertise, submitting constructive recommendations and assisting regulatory bodies in explaining new regulations to Chamber member companies.