The Legislative Affairs Office of the State Council the State Food Drug Administration jointly promulgated the newly revised regulations on the administration of medical devices, which clearly stated that the principle of different categories of supervision on medical devices would be implemented according to the principle of risk low to high.

The most significant change in the new version of the regulations on the administration of medical devices is that the medical devices are classified into categories I, II III low risk to high score, the category I medical device products are changed registration to record management; the level II medical device registration approval authority is delegated to the provincial food drug regulatory department; the category III medical devices, such as disposable sterile syringes, cardiac pacemakers other safety risks are high, the national food The SFDA shall strictly supervise the registration, strengthen the adverse event monitoring system, post market re evaluation system recall system.

According to the new regulations, a unified information platform for medical device supervision shall be established throughout the country, through which the food drug regulatory authorities shall timely publish information such as medical device licensing, filing, random inspection, investigation punishment of illegal acts. In addition, the new regulations set up a complaint reporting system reward verified reports.

The new "Regulations" increase the punishment of illegal acts. For example, severe penalties are imposed for the unauthorized production operation of medical devices, a maximum fine of 20 times the value of the goods is stipulated.

The new version of the regulations on the administration of medical devices is scheduled to be implemented June 1.

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Permit management is required for one-off needle management

Wang Zhenjiang, director of the Department of education, science, culture health of the Legal Affairs Office of the State Council, explained classified supervision as follows: to "pressurize" high-risk product production operation enterprises, to "loosen" low-risk product production operation enterprises.

Specifically, the new version of the regulations has new changes in the registration operation of medical devices. In the registration process, it is clear that the first type of medical devices shall be subject to the product registration management, the second type shall be subject to the implementation of the product registration management by the provincial food drug administration, the third type shall be subject to the implementation of the product registration management by the state food drug administration; in the operation process, the operation of the first type of medical devices shall be released, neither permitted nor filed. The second category of medical devices shall be subject to record management, the third category of medical devices, such as disposable sterile syringes, shall be subject to license management.

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Medical devices are divided into three types of supervision

Class 1: medical devices that can ensure their safety effectiveness through routine management, such as medical beds, scissors, forceps, etc. for basic surgical operations.

The second category: medical devices whose mechanism has been internationally domestically recognized whose technology is mature whose safety effectiveness must be controlled, such as thermometers, sphygmomanometers, stethoscopes, clinical examination instruments, electrocardiographs, etc.

The third category: medical devices implanted into human body, used for life support, with complex technical structure, which are potentially dangerous to human body, whose safety effectiveness must be strictly controlled, such as disposable sterile syringes, disposable sterile infusion sets, cardiac pacemakers, blood purification equipment, artificial organs, etc.