Medical device laws and regulations will be issued intensively, and the industry is on the verge of "change"

The new version of "Regulations on supervision and administration of medical devices" may be just the beginning of its promulgation, and more large-scale "renewal" is brewing in the medical device industry laws and regulations On Wednesday, an official of Jiangsu food and Drug Administration said that there are about 30 decree level laws and regulations under research and development, which are expected to be intensively promulgated in the past two years "The regulations to be issued involve all aspects of the life cycle of medical devices, which will have a great impact on the market and enterprise marketing system, and the impact is expected to be reflected in the next two years." The official said He disclosed that the upcoming regulations will cover the research and development, production, circulation and use of medical devices in an all-round way, including the introduction of high-risk medical device catalog, the addition of clinical evaluation procedures, the approval of clinical trial institutions for medical devices, the innovation of special evaluation procedures for medical devices, etc.; the production process includes GMP certification, etc.; the circulation process includes Internet sales, third-party sales, etc Logistics and operation quality management standards, etc.; the use of links including the development of yellow and black list, comprehensive launch of electronic supervision, adverse event monitoring and product recall, etc Different from drug supervision, it is common that the supervision of medical devices is not in place in China, the management rules are rough, and the supervision information is not networked, which makes it difficult to strictly supervise the quality and price Since last year, the state has gradually begun to implement stricter supervision on the price and use of medical consumables by organizing provincial high-value consumables centralized bidding and procurement.