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A... Specific requirements for the declaration of 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 the certificate 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 Classification Catalog". "Medical Device Classification Catalog" to fill in after checking
5) The contents of the fill shall not be altered
2, proof of ownership or use of housing:
Requirements: the enterprise registered address and warehouse address of the lease relationship or property rights of the more complex issues, you must provide the relationship of joint and several related Proof of documents.
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 technical personnel
2) must be accompanied by a copy of the academic qualifications of all technical personnel and title certificates. Certificates of all technical personnel must be attached to a copy of the certificate, 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, change the license is divided into the change of licensing matters and registration matters.
6.1 License matters including quality management personnel, registered address, business scope, warehouse address;
Change of quality management personnel, should be submitted to the new quality management personnel's identity card, certificate of academic qualifications or a copy of the certificate of title;
Change of registered address of the enterprise should be submitted at the same time to the change of the address of the property rights of the proof of ownership or copy of the lease agreement, Geographic location map, floor plan and storage conditions;
Change of business scope, should be submitted at the same time to operate a copy of the product registration certificate and the corresponding storage conditions;
Change of warehouse address, should be submitted at the same time after the change of the warehouse property rights or a copy of the lease agreement, geographic location map floor plan and storage conditions.
6.2 Registration matters including business name, legal representative.
Changes in registration matters must be submitted to the administrative department for industry and commerce issued by the documents certifying the changes.
If the name of the enterprise is changed, the approved notice of name change or a copy of the new business license that has been changed with the signature of the original legal person plus the original official seal should be submitted to the Industrial and Commercial Bureau for permission;
If the legal representative is changed, the new business license that has been changed should be submitted with a copy of the original signature of the original legal representative plus the original official seal and the signature of the shareholders.
7, the replacement of the "Medical Device Business License", shall fill out the medical device business license application form.
8, all the declaration materials must be printed or copied on A4 paper, and stamped with the official seal or signature of the legal representative, the new applicant if there is no company seal, the legal representative of the enterprise must sign the declaration information.
9, 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;
2, with an indoor warehouse compatible with the scale of operation, the 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 fluid), Class III 6846 implantable materials and artificial organs, Class III 6877 interventional devices
Requirements: 1, the person in charge of the enterprise should have college education or intermediate (or above) or above title;
2, specialized in professional services and business management. 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: 1, the quality manager should have a medical device related professional secondary school (or more) or junior (or more) title.
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 archive files;
4, should be equipped with appropriate facilities and equipment, such as slit-lamp microscope.
There shall be no less than 5 personnel (college degree or above or intermediate title or above);
3. The quality manager shall have a bachelor's degree or above in medical specialty or the title of attending physician (or above).
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
I don't know which province you are in? You go to the location of the provincial Food and Drug Administration website can be queried, I hope my answer is useful to you, and finally wish your company open soon.