37 new standards for medical devices, industry standards system constantly improved

Pharmaceutical Network Industry Dynamics: Medical device standards are the technical specifications that medical devices are jointly followed in the development, production, operation, use and supervision and management, and are important technical support for medical device supervision and industrial development, so the improvement of the standard system is of great significance to the whole industry
In recent years, the State Drug Administration attaches great importance to the work of medical device standards, and constantly improve the medical device standards management system, and continuously carry out the revision of medical device standards system, so that China's medical device standards system is constantly improved, supervision and industrial development of the technical support capacity continued to improve
March 2 news, the Drug Administration YY0167-2020 "non-absorbent surgical stitching" and other 7 medical device industry standards and YY/T 0935-2014 "CT imaging injection device special technical conditions" medical device industry standard modification single validation, is now published
On the same day, the State Drug Administration approved and published six medical device industry standards, such as YY/T 0292.1-2020 Medical Diagnostic X-ray Radiation Protection Device Part 1: Measurement of Material Attenuation Performance
On February 21, the State Drug Administration issued a notice that YY 0833-2020 "General Technical Requirements for Limb Pressurized Physiotherapy Equipment" and other 24 medical device industry standards and YY 0104-2018 "three prism" and other 6 medical device industry standards modification list has been approved, is now published
Statistics show that since 2020, 37 new medical device industry standards, 7 medical device industry standards have been revised and releasedWith the development and improvement of industry standards, the domestic medical device industry will be more conducive to the direction of standardization, standardization, high-quality development, accelerate the import of replacement
The medical device industry belongs to the strategic emerging industries supported in the national keyIn recent years, with the acceleration of the state's encouragement of innovation and drug review and approval, the domestic pharmaceutical equipment market continues to develop, the current market growth rate of China's medical device market is about 20%, and from 2006 to 2016 the compound annual growth rate is about 23.89 percentThe industry believes that the industry has ushered in a golden period of development, import substitution accelerated
According to the China Medical Device Industry Association, the next five years of domestic compound growth will also reach 15-20%With the continuous improvement of medical technology, as well as the aging of the population, domestic support for the development of medical devices and other favorable policies to promote, high-end medical devices are expected to help precision medicine, become the next wind
In the context of considerable industry prospects, in order to strengthen the quality supervision and management of medical devices, to ensure the safe and effective use of medical device products, the State Drug Administration in addition to promoting standards, in recent years, the supervision of the industry has never been reduced
On January 22, the State Drug Administration issued a notice on the results of the national medical device supervision and sampling, which showed that the agency organized quality supervision and sampling of eight medical device products, such as patient monitors, hemodialysis and related therapeutic concentrates, and a total of 19 batches (Taiwan) products did not meet the standardsThe bureau has asked the provincial drug supervision and administration department where the enterprise is located to urge the relevant enterprises to conduct risk assessment of products that do not meet the standards, to determine the recall level according to the severity of medical device defects, to actively recall products and disclose recall information;
In addition, during the outbreak, in order to ensure the safety of medical devices for the prevention and control of drugs in the outbreak of new coronavirus infection pneumonia, on February 4, the State Drug Administration issued a notice on cracking down on the illegal activities of medical devices for the production and sale of counterfeit and inferior drugs, deploying from five aspects, cracking down on all kinds of illegal and criminal acts, and effectively maintaining the order of the drug medical device market during the epidemic prevention and control period