I.Product performance
One of the requirements of in vitro diagnostic instruments different from other medical devices is that clinical project analysis performance research should be carried out. Considering the situation of the detected substances and the main functions of the product (for example, quantitative / qualitative analysis, different detection methods / modes, etc.), representative items are selected for research according to different types of analytes and different functions of the instrument. it should be repeated many times and include the process of confirmation and verification. Research items generally include accuracy, repeatability, linearity, stability, carrying pollution and so on. more…
I.General situation
In 2021, China’s total foreign trade in medical devices reached 134.94 billion US dollars, a year-on-year decrease of 18.8%. Among them, the import volume was US $50.21 billion, a year-on-year increase of 18.4%; the export volume was 84.73 billion US dollars, a decrease of 31.5%. more…
In January 2022, the National Health Commission, NMPA, NIFDC and other departments successively issued a number of policies, regulations, notices and announcements for the medical device industry (including IVD industry). In order to facilitate the inquiry of people in the industry and provide clear, fast and effective services, we have collected and sorted these documents in a centralized manner. The directory is as follows: more…
In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, according to the Administrative Measures for Registration and Filing of Medical Devices (Order No. 47 of the NMPA), NMPA has organized and formulated relevant technical guidelines. more…
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…
