Last December 2nd, the Suzhou Municipal Food and Drug Administration destroyed 120 thousand boxes of counterfeit medicines, medical equipment, health care products, the total value of nearly 1 million yuan.

Beijing News (reporter Wei Mingyan) yesterday, the office of the State Council, the State Food and Drug Administration jointly issued a new revision of the "medical devices regulations", defined according to the risk from low to high principle, medical instrument for the implementation of the public has other regulatory classification principle.

The most significant change version of "medical devices regulations", is a medical device by risk from low to high to one or two, class three, a class of medical equipment products registered by the changed record management; two level medical device registration approval authority delegated to the provincial food and drug regulatory authorities; three types of medical equipment such as disposable sterile syringes, pacemaker safety risk is high, the strict supervision of registered by the State Food and drug administration, but also strengthen the adverse event monitoring system, and then evaluate the market system and recall system.

The new "Regulations" provisions, the establishment of a unified information platform for medical supervision, food and drug supervision departments through the platform according to the timely disclosure of medical licensing, filing, inspection, investigate violations and other information. In addition, the new regulations additional complaint reporting system, and reward verified report.

New regulations to increase penalties for illegal activities. For example, the unauthorized production and operation of medical devices, the implementation of heavy penalties, the maximum value of 20 times the amount of fines.

Disposable needle tube business license management

The State Council Legislative Affairs Office esch Secretary Wang Zhenjiang explained to the regulatory classification: high risk products production enterprises pressure, to low-risk products production enterprises relaxed".

Specifically, the new version of the regulations on the classification of medical devices in the product registration and management of new changes. The registration link, clear the first class of medical equipment to implement the product record management, second class implementation of product registration by the provincial food and drug supervision departments, third by the State Food and Drug Administration Implementation of product registration management; business link, let go of the first class of medical equipment business, neither license nor the implementation of the record. Second types of medical equipment for the implementation of the record management, the implementation of the license for the management of third types of medical devices such as disposable sterile syringes.