According to the official website of the State Food and drug administration, in order to ensure the safety and effectiveness of medical devices, the State Food and Drug Administration recently issued the catalogue of prohibited entrusted production of medical devices, which will come into force on May 1, 2022. Among them, implantable cardiac pacemakers, implantable circulatory AIDS, intracranial stent systems, plastic filling materials, plastic injection fillers, breast implants and other medical devices are prohibited from being commissioned for production. The relevant person in charge of the State Food and Drug Administration said that the catalogue of medical devices prohibited from entrusted production was revised on the basis of the notice on Issuing the catalogue of medical devices prohibited from entrusted production (formerly No. 18 of the State Food and Drug Administration in 2014). The main amendments are reflected in two aspects: first, on the basis of the original catalogue, combing according to the classification catalogue of medical devices (revised in 2017), further clarifying the variety range and determining the classification catalogue code, so as to enhance the operability. The second is to modify the contents of the catalogue and delete products such as implantable islet pump and absorbable surgical hemostatic materials with relatively mature production technology and relatively low risk. It is understood that the varieties of medical devices prohibited from commissioned production are mainly due to their high risk. According to Article 34 of the regulations on the supervision and administration of medical devices, the registrants and recorders of medical devices can produce medical devices by themselves, or entrust enterprises that meet the provisions of these regulations and meet the corresponding conditions to produce medical devices. Implantable medical devices with high risk shall not be commissioned for production, and the specific catalogue shall be formulated, adjusted and published by the drug regulatory department under the State Council. Catalogue of prohibited medical devices 1、 Active implant Implantable pacemaker (12-01-01) Implantable cardiac contractility regulator (12-04-01) Implantable circulatory AIDS (12-04-02) 2、 Passive implant Dural patch (excluding products without animal derived materials) (13-06-04) Intracranial stent system (13-06-06) Blood flow guiding device for intracranial aneurysms (13-06-11) Cardiovascular implants (except peripheral vascular stents, vena cava filters and cardiovascular embolization devices) (13-07) Shaping filling material (13-09-01) Injection filler for plastic surgery (13-09-02) Breast implants (13-09-03) Tissue engineering scaffold materials (excluding products without allogeneic or animal derived materials) (13-10) Absorbable surgical anti adhesion dressing (excluding products without animal derived materials) (14-08-02) 3、 Other allogeneic implantable medical devices and implantable medical devices directly derived from animal tissues. Note: the number in brackets after the product name is the category code of medical device classification catalogue (2017 Edition). (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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