On March 24, the official website of the State Food and Drug Administration released four official notices related to medical devices. Among them, the announcement on adjusting some of the contents of the Medical Device Classification Catalogue has aroused widespread concern in the industry.
Screenshot of the State Drug Administration.
"This adjustment is mainly an adjustment of downgrading, and the requirements for some medical equipment have been reduced." Xu Shan, secretary general of the China Medical Device Industry Association, told the People's Daily health client reporter that this relaxation must be based on certain evidence-based medical evidence, and the timely adjustments made under the premise of ensuring safety are simpler, both in terms of management and enterprise registration.
According to the content of the circular, according to the actual development and supervision of the medical device industry, in accordance with the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices and the Dynamic Adjustment of the Classification Catalogue of Medical Devices, the State Food and Drug Administration decided to adjust some of the contents of the Classification Catalogue of Medical Devices, and the adjusted instruments include 02-passive surgical instruments, 03-neural and cardiovascular surgical instruments, 13-passive implantable instruments, 14-infusion, nursing and protective equipment classification.
"In fact, the classification catalogue of medical devices has been dynamically adjusted, which fully demonstrates that the State Food and Drug Administration has continued to exert efforts in the field of medical devices in recent years, paying close attention to evidence-based medicine, and adjusting the management and approval of medical devices used in a timely manner." An industry insider in the direction of health equipment technical assessment of the China Medical Equipment Association said that the most noteworthy thing about this adjustment is that a number of medical device management has been downgraded.
The reporter found that in the 10 major categories of medical devices adjusted this time, only one product liquid, paste dressing (non-sterile provision) was upgraded from Class I to Class II, and the others were unchanged or downgraded.
According to the "Medical Device Classification Rules" issued by the former State Food and Drug Administration, hospital medical devices can be divided into three categories according to the risk level, the first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management; the second category refers to medical devices whose safety and effectiveness should be controlled; the third category refers to medical devices that are implanted in the human body; used to support and maintain life; medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.
The above-mentioned industry insiders indicated that "the downgrading of multiple medical devices from Class 3 to Class 2 is definitely a certain guarantee for the safety of this type of medical device in the long-term use and testing, and after the downgrade, the management of medical devices and the approval of enterprises will provide certain convenience, but once such medical devices have problems, the State Food and Drug Administration will definitely adjust its relevant classification in time." ”
Reporter Wang Aibing
