I. Specific requirements of the enterprise declaration materials:
1, "Medical Device Business License Application Form"
Requirements: 1) two copies (downloaded online)
2) "Business Name "must be pre-approved for industry and commerce
3) "Registered address" and "warehouse address" must be filled in with proof of property rights or the right to use the house and other relevant documents
4) "The scope of products to be operated": must be based on the actual enterprise, and with the "medical device catalog" to fill in after checking the correct
5) The contents of the filling shall not be altered
2, proof of property rights or the right to use the house:
Requirements: enterprise registered address and warehouse address of the lease relationship or property rights issues are more complex, must provide the relevant documents to prove the joint relationship.
3, list of technical personnel and academic qualifications, certificates of title
Requirements: 1) "list of technical personnel" must be declared according to the scope of products to be operated by the enterprise to fill in the corresponding requirements of the required technical personnel
2) must be accompanied by a copy of the academic qualifications of all technical personnel and titles Copies of certificates must be attached to all technical personnel, and there shall be no omissions.
4, quality management documents directory
Requirements: the directory must include the acceptance criteria for the twelfth requirement of the management system
5, the business premises, warehouse floor plans
Requirements: 1) the floor plans must be clearly marked
2) business premises plan must be marked business divisions, the warehouse floor plan must be marked with the partition and the specific area number And the specific area of the number of
6, all the declaration materials must be printed or copied on A4 paper and stamped with the official seal or signature of the legal representative of the new applicants, such as if there is no company seal, the legal representative of the enterprise must be signed on the declaration information.
7, issued before 2005, "Medical Device Business License" of the enterprise for change or replacement matters, must be in accordance with the "Guangdong Province, medical device business on-site inspection and acceptance of standards (for trial implementation)" of the specific requirements submitted to the quality of the manager, the warehouse address related to the declaration of information.
Two, on-site inspection and acceptance should be noted:
1, the enterprise must be in accordance with the "Guangdong Province, medical equipment business on-site inspection and acceptance of standards (for trial implementation)" of the specific requirements of the full preparatory work, before submitting the declaration.
2, the day of the on-site inspection, the person in charge of the enterprise, quality manager and other relevant technical personnel must be present.
Third, with the enterprise to declare the business scope corresponding to the requirements of the conditions: (see "Guangdong Province, medical equipment business enterprises on-site inspection and acceptance criteria (for trial implementation)")
Class A: 6815 injection and puncture instruments (single-use sterile syringes), 6866 medical polymer materials and products (single-use transfusion (blood) devices (needles) class)
Requirements: 1, the quality manager should have a college (including) or above or intermediate (including) or above title;
2, with an indoor warehouse compatible with the scale of operation, warehouse area of not less than 200 square meters.
Category B: Class III 6821 medical electronic instruments and equipment, Class III 6822 medical optical instruments, instruments and endoscopic equipment (except contact lenses and their care fluids), Class III 6846 implantable materials and artificial organs, Class III 6877 interventional devices
Requirements: 1, the person in charge of the enterprise shall have college education or above, or an intermediate (including) or above;
2, specialized in professional services and business management, and has a warehouse area of not less than 200 square meters. p>
2, no less than five professional and technical personnel (college degree or above or intermediate (or above) title);
3, quality management should have a bachelor's degree in medicine (or above) or attending physician (or above) title.
Category C: equipment: 6823 medical ultrasound instruments and related equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physical therapy and rehabilitation equipment, 6828 medical magnetic **** vibration equipment, 6830 medical X-ray equipment, 6831 medical X-ray accessory equipment and components, 6832 medical high-energy radiation equipment, 6833 Medical nuclide equipment, 6840 clinical testing and analysis instruments, 6845 extracorporeal circulation and blood processing equipment, 6854 operating room, emergency room, diagnostic and treatment room equipment and appliances;
Medical large-scale equipment, including: 6824 medical laser instrumentation, 6825 medical high-frequency instrumentation, 6828 medical magnetic **** vibration equipment, 6830 medical X-ray equipment. 6832 medical high-energy radiation equipment, 6833 medical nuclide equipment.
Requirements: 1, the person in charge of the enterprise should have college (including) or more education or intermediate (including) or more titles;
2, professional and technical personnel of not less than 3 people;
3, quality management should have a bachelor's degree (including), more than 2 years of experience or intermediate (including) or more titles;
4, should have the products operated by the training and After-sales service capabilities, or agreed to provide technical support by a third party; 5, the warehouse area of not less than 40 square meters, of which only the operation of medical large-scale equipment category warehouse area of not less than 20 square meters.
Category D: 6863 stomatology materials, 6864 medical hygiene materials and dressings, 6866 medical polymer materials and products (disposable infusion (blood) devices (needles) except class)
Requirements: 1, the warehouse area of not less than 100 square meters.
Category E: diagnostic reagents
Requirements: 1, quality management personnel, not less than one person with a college degree in medicine, pharmacy, chemistry or biology or intermediate or above;
2, should be set up for refrigeration equipment, with a total volume of not less than 3 cubic meters;
3, equipped with facilities and equipment to meet the requirements of the reagent transportation.
Category F: soft, rigid (gas permeable) corneal contact lenses (commonly known as contact lenses) and their care fluids
Requirements:
Requirements:
1. The quality manager should have a secondary school education or a junior (including) or above title in medical device related majors.
2, should be equipped with at least one junior (including) or more optometrists or ophthalmologists (including) or more professional and technical personnel;
3, should be established, including corneal contact lenses wearer management files and other quality management system and archival documents;
4, should be equipped with appropriate facilities and equipment, such as slit-lamp microscopes and other facilities and equipment
According to the "medical device business enterprise License Management Measures" (State Food and Drug Administration Order No. 15) of the third regulation, the operation of the second and third class of medical devices should hold a "medical device business license", the operation of the first class of medical devices do not need to apply for a "medical device business license"; in the circulation process through the routine management of a few of the second class of medical devices can ensure its safety, effectiveness can not apply for a "medical device business license". Medical Device Business Enterprise License", the specific directory developed by the State Food and Drug Administration, has published the first batch of medical devices do not need to apply for "Medical Device Business Enterprise License" of the second class of medical device product list, see "on the publication of the first batch of medical devices do not need to apply for & lt; Medical Device Business Enterprise License & gt; second class of medical device product list of the notice" (SFDA city [2005] No. 239), involving the first class of medical devices do not need to apply for "Medical Device Business Enterprise License". 2005] No. 239), involving 13 products, currently operating in addition to 13 products other than Class II medical device companies should hold a "medical device business enterprise license".