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Catalogue of National Key Regulatory Medical Devices (2009 Edition)
1. single-use sterile medical devices 1. Sterile syringes for single use; 2. Disposable infusion set; 3. Single-use blood transfusion device; 4. Single-use burette infusion set; 5. Disposable intravenous infusion needle; 6. Sterile injection needle for single use; 7. disposable plastic blood bag; 8. Single-use blood collection device; 9. Disposable anesthesia puncture kit; 10. Medical suture needle (thread). 2. Orthopaedic Implants Medical Devices 1. Surgical implants, joint prostheses; 2. Metal straight and special-shaped bone plates; 3. Metal boning and orthopedic nails; 4. Metal orthopedic rods; 5. Intramedullary needle, bone needle; 6. Spinal internal fixation equipment. 3. implantable medical devices 1. Intraocular lens; 2. Artificial heart valves; 3. Cardiac pacemaker; 4. Endovascular stent, catheter, guide wire, balloon. 4. filling material 1. Breast filling material; 2. Intraocular filling materials; 3. Orthopedic filling materials. 5. allogeneic medical devices 1. Allogeneic bone; 2. Allogeneic skin; 3. Biological amniotic membrane. 6. medical devices of animal origin 1. Artificial biological heart valve; 2. Biological protein sponge; 3. Biofilm; 4. Xenogeneic bone repair materials; 5. Biological dressings; 6. Tissue-engineered full-thickness skin; 7. Bioadhesive. 7. medical devices for family planning 1. Intrauterine device; 2. Rubber condoms. 8. extracorporeal circulation and blood treatment medical devices 1. Hollow fiber dialyzer; 2. Hemodialysis device; 3. Dialysis powder, dialysis fluid; 4. Plasma separation cup, plasma pipeline. Anti-adhesion medical devices for 9. surgery 10. orthokeratology lens XI. Infant Incubator XII. Medical protective masks and medical protective clothing
Hunan Provincial Bureau Launching Special Action of "Hundred Days Rectification" of Medical Equipment
A few days ago, the Hunan Food and Drug Administration, with the cooperation of the public security department, conducted a comprehensive inspection of the non-drug counterfeit drug sales behavior of 20 drug-related units including the Gaoqiao Market Medicine Circulation Park in Changsha City. During the inspection, the bureau found 147 suspected non-drug counterfeit drug varieties and seized non-drug 1585 boxes (bottles). This is the first campaign of the "100-day rectification" of pharmaceutical and medical devices in Hunan Province. In response to the widespread problems of non-medicines passing off as medicines in the province, the Hunan Provincial Bureau has identified the focus of the "100-day rectification" action as the wholesale market for health products and special stores for health products; distribution of advertised medicines and non-medicines
Counterfeit Drug Snake Venom Enzyme Injection Found in Changde City
Recently, Changde Municipal Food and Drug Administration conducted a verification according to the clues reported by the masses. It was found that the snake venom enzyme injection used by a medical unit in Changde City, which was produced by Jilin Huinan Huifa Pharmaceutical Co., Ltd. with the approval number of H22029586, batch number of 20090111 and specification of 2ml:2mg, was confirmed to be counterfeit after verification with the local drug administration department of the manufacturer. At present, the food and drug supervision and administration departments at all levels in the province have organized a comprehensive inventory, and the case is being further dug and dealt. (Hunan Provincial Food and Drug Administration Inspection Team)
