In October 2014, the Beijing Municipal Drug Administration for the three types of medical devices, class II medical devices introduced a number of new policies: since October 2014, all medical devices related to the approval of the project by the front approval into the approval of the latter, and the scope of operation of the second class of medical devices will not be embodied in the medical device license above, the implementation of the filing system. Class III medical device products need to be approved by the Drug Administration to obtain a medical device license before operating.
Specific requirements are as follows:
(a) the operation of Class Ⅲ, Class Ⅱ in vitro diagnostic reagents, the use of business premises area of not less than 100 square meters, the use of the storage area of not less than 60 square meters, the cold storage volume of not less than 20 cubic meters. (Remarks: only engaged in the retail business of Class II in vitro diagnostic reagents shall meet the requirements of the third paragraph of this Article).
(B) the operation of Class Ⅲ medical devices, shall have with the scale of operation of the business premises and warehouse:
1. Business class code for Ⅲ-6821 medical electronic instruments and equipment, Ⅲ-6846 implantable materials and artificial organs, Ⅲ-6863 stomatological materials, Ⅲ-6877 interventional device products, the use of the business premises shall not be less than 100 square meters, the use of storage space shall not be less than 40 cubic meters. The use of storage area shall not be less than 40 square meters.
2. Business class code for Ⅲ-6815 injection and puncture instruments, Ⅲ-6845 extracorporeal circulation and blood processing equipment, Ⅲ-6864 medical hygiene materials and dressings, Ⅲ-6865 medical suture materials and adhesives, Ⅲ-6866 medical polymer materials and products, the use of the business premises area of not less than 60 square meters, the use of the storage area of not less than 80 square meters. The use area of the warehouse shall not be less than 80 square meters.
3. Engaged in the class code for Ⅲ-6822 medical optical instruments, instruments and endoscopic equipment (soft corneal contact lenses only) category of retail business, there should be an independent counter; which provides fitting services, the use of business premises area of not less than 30 square meters, optometry room (area) should have a dark room conditions or to meet the conditions of no direct lighting.
4. In addition to the above class code other than Class III medical devices, the business premises shall not be less than 60 square meters, and equipped with warehouses appropriate to the scale of operation.
(C) the operation of Class II medical devices, should be equipped with business products and scale of business premises and warehouse.
Engaged in the class code II-6846 implantable materials and artificial organs (hearing aids) class retail business, should also set up a separate hearing test room, fitting room, effect assessment room.