Two, a class, class II, class III medical device catalog:
A class, class II and class III terminology management category, see the supervision and management of medical devices regulations have relevant provisions. Management from low to high. Medical device, refers to the use of the human body alone or in combination with instruments, equipment, appliances, materials or other items, including the required software; its use on the human body surface and in vivo is not pharmacological, immunological or metabolic means of obtaining, but there may be these means to participate in and play a certain auxiliary role; the use of its intended purpose: (1) the prevention, diagnosis, treatment, monitoring and alleviation of disease (1) the prevention, diagnosis, treatment, monitoring, and alleviation of disease; (2) the diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability; (3) the study, substitution, and regulation of anatomical or physiological processes; (4) the control of pregnancy. Medical devices are divided into three categories: Class I medical devices are: Basic surgical knives "scalpel handles and blades, scalpel knives, wart removal knives, lancets, spatulas, shaving knives, dandruff shavers, picking knives, sharp knives, pedicure knives, manicure knives, dissecting knives and so on." Class II Medical Devices: (a) General Diagnostic Instrument Class (6820): thermometers, sphygmomanometers; (b) physical therapy and rehabilitation equipment class (6826): magnetic therapy apparatus; (c) Clinical Laboratory Analyzers (6840): home blood glucose analyzers and test strips; (d) operating room, emergency room, diagnostic and therapeutic equipment and appliances class (6854): medical oxygen concentrator portable oxygen generator; (e) Medical hygiene materials and dressings class (6864): the Quantum of oxygen; (f) Medical hygiene materials and dressings class (6864): the Quantum of oxygen; (g) Medical hygiene materials and dressings class (6864): the Quantum of oxygen; (h) Medical hygiene materials and dressings class (6864): the Quantum of oxygen; (f) medical polymer materials and products (6866): condoms, contraceptive caps, etc. Class III Medical Devices: A. Single-use sterile medical devices 1, single-use sterile syringes; 2, single-use infusion sets; 3, single-use blood transfusion sets; 4, Single-use anesthesia puncture kit; 5, single-use intravenous infusion needle; 6, single-use sterile hypodermic needle; 7, single-use plastic blood bag; 8, single-use blood collector; 9, single-use burette-type infusion set. B, orthopedic implants medical devices 1, surgical implants joint prosthesis; (except for single-use sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices) and so on.Three, medical equipment business premises, warehouse area requirements:
1. Operating Class II, Class III medical device products, the business premises should be used in an area of not less than 40 square meters, the use of legal entity branches should be used in an area of not less than 25 square meters (except for the set up of the city of the cross-border area); hearing aids, hearing aids, the use of the business premises should be used in an area of not less than 25 square meters (except for the set up of the city). Business premises should be no less than 25 square meters; contact lenses and care solutions, business premises should be no less than 10 square meters. 2. Business Class II, Class III medical devices (hearing aids, contact lenses and nursing fluids, single-use sterile medical device products in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices, except), the use of warehouses should be no less than 30 square meters; the operation of single-use sterile medical devices, warehouses should be in the same building, the use of the area Should not be less than 200 square meters. 3. Legal entity branches (except for the establishment of municipalities across the region) and specializing in medical equipment and equipment, may not set up a separate warehouse, but should be stamped with a legal entity or authorized to operate the product manufacturer (including the import agent) the original seal of the original seal of the relevant procurement and distribution of uniform quality management, installation and after-sales service commitments, as well as specializing in the product's certificate of registration, authorization documents and other proof. Proof. 4. Business hearing aids or contact lenses and their care solution, you can not set up a warehouse, but there should be a special cabinet. 5. Declared business premises and warehouses in principle in the same administrative area near the set up, and shall not be located in civilian homes, troops, public security, armed police barracks.Four, the medical device enterprise personnel qualification requirements:
1. The operation of the third class of medical equipment products, quality management, quality institutions should have a nationally recognized, and the management of products related to the profession (medical equipment, biomedical engineering, machinery, electronics, etc.) college degree or more, or intermediate or above the technical title of the relevant professional. The following is a list of the products The operation of single-use sterile medical devices, there should be more than one medical device quality management system with an internal auditor certificate of the internal auditor (not by the quality manager concurrently). 2. The operation of the second class of medical device products, quality management, quality institutions should have a nationally recognized, and management of products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) above the junior college education or related professional technical title above the primary level. 3. Management of second and third class medical device products, technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) and other products should be operated with the management of the relevant professional secondary school education or more than junior technical title. 4. Management of hearing aids or contact lenses and care fluids, quality management should be recognized by the state third-party institutions or authorized to operate the production company (including import agents) contact lens fitting technology training. 5. Quality management and quality organization shall not be part-time.