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Revised Regulations on Supervision and Administration of Medical Devices Announced
Escort for health, protect the safety of medical equipment-ruddy media into Hunan Ping An Medical Equipment Technology Co., Ltd.
In the early morning of April 9, ruddy media and his party set out from Changsha and drove to Hunan ping an medical equipment technology co., ltd. (hereinafter referred to as ping an medical equipment) located in Li county economic development zone of Changde city to shoot relevant materials for the production of promotional films of the provincial medical equipment association. at the same time, they interviewed and learned from this medical equipment research and development enterprise with a history of more than 20 years to communicate the enterprise's film and television cooperation. After coming to the factory area of Ping An Medical Equipment and having an in-depth understanding of the development of Ping An Medical Equipment, we were left with the impression that this is a professional, rigorous, down-to-earth enterprise that produces safe and assured medical equipment products for the health of the people. In cooperation with Ping An Medical Equipment Chairman, Party
Medical equipment "five rectification" special action carried out in the country
On March 17, the State Food and Drug Administration announced at a press conference that in order to solve the hot and difficult problems of medical devices with high social concern and strong public reaction, further standardize the market order and severely crack down on violations of laws and regulations, the General Administration decided to carry out a five-month "five rectification" special action of medical devices nationwide from the middle of March, focus on the rectification of medical devices false registration declaration, illegal production, illegal operation, exaggerated publicity, the use of unlicensed products and other five acts. In recent years, China's medical device industry has developed rapidly, and on the whole, the safety situation of medical devices is stable and good. However, due to our country
CFDA says comprehensive revision of medical device regulations this year
On March 4, officials of the State Food and Drug Administration said at the forum of representatives of the two sessions of the pharmaceutical industry that the documents, regulations and regulations on medical devices will be comprehensively revised this year. Industry insiders said that in February, the executive meeting of the State Council just deliberated and passed the "Regulations on the supervision and administration of medical devices (Revised Draft)" (hereinafter referred to as the "draft"), and these amendments should be carried out around this "draft. On February 12, Premier Li Keqiang of the State Council deliberated and passed the above-mentioned "Draft" at the executive meeting. This "late" revised regulation will be officially promulgated after 7 years. According to industry insiders, classified management and encouraging innovation are two of the draft.
Changde cracked a cross-provincial case of producing and selling counterfeit medical devices involving nearly 10 million yuan.
After forging the medical device manufacturer's license and medical device registration certificate, the fake and inferior "Yongle Shengong pain-killing bag" produced by it will be delivered to 15 provinces including Hunan, Shandong, Zhejiang, Jiangsu, Shaanxi and Henan through logistics distribution. A reporter from the Legal Daily learned from the Public Security Bureau of Changde City, Hunan Province today that the public security detachment of the bureau successfully cracked a case involving 43 sales in 15 provinces and cities (districts) including Hunan and Shandong, and the amount involved was nearly 10 million yuan. In the case of selling fake medical devices, the main suspect Wan Mou was arrested on suspicion of producing and selling fake and inferior products. On October 21 last year, Changde City Public Security Bureau
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)
