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

Source: the new version of "Regulations on the supervision and administration of medical devices" issued by great wisdom astak news agency on September 23, 2013 may be just the beginning, and the medical device industry laws and regulations are brewing a larger scale of "renewal" On Wednesday, an official from the Jiangsu food and Drug Administration said that there are still about 30 decree level regulations under study 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 including GMP certification, etc.; the circulation process including Internet sales, the third Square logistics and operation quality management standards; the use of links including the development of yellow and black list, comprehensive launch of electronic supervision, adverse event monitoring and product recall 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 centralized bidding and purchasing of provincial high-value consumables.