In June 2021, NMPA has approved a total of 163 medical devices. Among them, 110 of them are domestic class III medical devices, 28 of them are imported class III medical devices, 23 of them are imported class II medical devices, and 2 of them are medical devices from Taiwan of China. more…
According to the newly revised Regulations on the Supervision and Administration of Medical Devices released on June 1, 2021, NMPA will further strengthen regulatory measures, including prohibition of the import of expired, invalid, obsolete and used medical devices in any other forms. more…
China Mobile Communications Group Co., Ltd. recently has been granted a patent for the design of the “Portable Color Ultrasound Instrument”, according to theTianyancha APP. The announcement number is CN306650066S, and the application date is October 2020.According to the patent abstract, this design product is used as a portable color ultrasound instrument for medical testing. more…
In the field of lower limb arterial stents, China’s domestic market is basically occupied by international giants such as Medtronic, Boston Science, Cordis, BD, Abbott and so on, lack of strong competitors. Local companies in the R&D stage include Leao Medical, Guichuang Tongqiao, Yinluo Medical, Life Care, etc. Among them, Le Ao Medical announced in March 2021 that its randomized controlled clinical trial of peripheral arterial stents were completed ,and all 384 were enrolled in the group , becoming the first local peripheral arterial stent to complete clinical enrollment, and according to the data that completed clinical follow-up, the long-term patency rate of the peripheral arterial stent of Leao Medical is similar to that of the imported control product, and some of the evaluation indicators are even better than imported products, it is expected to break the monopoly pattern of imported arterial stents in one fell swoop after being listed in the future. more…
On July 8,China NMPA officially issued the “Guiding Principles for the Classification and Definition of AI Medical Software Products”(hereinafter referred to as the “Guiding Principles”).
In the last week of June, three innovative medical devices, recombinant type III humanized collagen lyophilized fiber, transccatheter aortic valve system and WEB aneurysmal embolization system, were approved by NMPA. China is encouraging the registration and marketing of innovative medical devices in recent years, please do not hesitate to contact us at info@ inspirativemed.com if you have any interest in bringing such innovative products into China. Detailed information about these medical devices is listed as below:
In recent years, the market share of medical devices in China is increasing, including medical imaging, in vitro diagnosis and other fields, Chinese government has continuously increased the support to the development of domestic medical devices, especially for innovative products.
The Finance Department of Sichuan Province of China, together with the departments of the medical and health industry, organized experts to demonstrate that there is a gap between domestic inspection equipment and imports, so it is difficult to meet the requirements of medical and health laboratories, and on this basis, a unified demonstration list of imported products is formed.
Ⅰ.Administrative acceptance of medical devices
A total of 7,453 Class I medical devices registered nationwide, among which 189 are imported Class I medical devices.A total of 4123 applications for first registration have been accepted throughout the country, including 3560 first registered medical devices of the second category, 377 first registered medical devices of the third category, and 186 imported first registered medical devices (including Hong Kong, Macao and Taiwan).A total of 3862 applications for renewal registration have been accepted nationwide, including 2460 domestic applications for category II medical devices, 516 domestic applications for category III medical devices and 886 applications for imported medical devices (including Hong Kong, Macao and Taiwan).
In order to strengthen the supervision and guidance of the registration of medical device products of vision screening instrument and mammography system, the State Food and Drug Administration (CFDA) on June 29 officially issued the “Guides for the Technical Examination of the Registration of Vision Screening Instrument” and “Guides for the Technical Examination of the Registration of mammography System”, aiming to further improve the quality of the registration examination(See attachment).
