Three medical device industry standards including YY 9706.274-2022 Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment have been approved and are now published. See the attachment for the standard number, name, scope of application and implementation date. more…
In recent years, the number of recalled medical devices at home and abroad has gradually increased. In 2021, 475 different types of medical devices were recalled, among which the more serious first-class recall events, such as the recall of the atrial septal puncture needle product (model tsnc-18-71.0) of Cook (China) due to the rust problem, Medtronic’s covered stent system was recalled due to manufacturing fusion problems. Although other recall events were rated as level II and level III, their impact should not be underestimated. more…
Recently, TargetingOne Corpation announcs that its independent research and development New Coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method) officially received the approval of NMPA medical device (National Instrument Approval: 20223400015). more…
On January 10, the executive meeting of the State Council of China decided to regularly carry out centralized procurement of drugs and high-value consumables, expand the centralized procurement of high-value medical consumables, and carry out centralized procurement of orthopaedic consumables, drug balloons and dental implants of general concern at the national and provincial levels respectively. This is the first time that the national centralized collection of dental implants has been defined at the national level. more…
On January 17th，in order to strengthen the supervision and guidance of the registration of drug-device combination products, and encourage the listing of drug-device combination products of clinical value, the NMPA has formulated two guidelines for registration review, namely, the Medical-device Combination Products with the Main Role of Medical Devices , and Research on the Qualitative and Quantitative and In vitro Release of Drugs in Drug-device Based on the Function of Medical Devices. more…
On the 17th, the NMPA issued a circular that in order to further improve the quality of registration review, the NMPA organized and formulated six registration review guidelines, including Disposable High Pressure Contrast Syringe and Accessories Products; Metal Bone Plate Internal Fixation System Products (revised in 2021); Degradable Magnesium Metal Orthopedic Implants; Microcatheter; Disposable Endoscope Needle and Intraocular Lens. more…
In 2021, a total of 36 medical device enterprises in China completed IPO, including 13 listed in Hong Kong Stock market, 19 on the Science and Technology Innovation Board and 4 on the Growth Enterprise Market, including MicroPort ，CardioFlow, Zylox-Tonbridge, WEGO Orthopaedic, Chunlizhengda Medical, Acotec Scientific, Bioheart, APT Medical in the fields of high value medical consumables such as cardiovascular and orthopedics，in the field of in vitro diagnosis, HOB, Biotest，Novogene，Basecare etc., and in the field of medical imaging equipment and AI medical imaging, CareRay，Airdoc, etc. more…
I. Approved class II and III medical devices:
In 2021, NMPA and provincial drug administrations approved 32450 class II and III medical devices, including 13326 first registered products and 19124 continued registered products. The first registered products accounted for 41.1%, lower than 57.1% in 2020. more…
