1, office area of not less than 50 square feet;
2, warehouse area of not less than 50 square feet; (including in vitro diagnostic reagents need to be refrigerated warehouses)
3, including disposable supplies, if you require the office address and the warehouse area of together can not be less than 150 square feet Note: The premises and warehouse shall not be set up within the residential area. Note: business premises and warehouses shall not be set up in residential housing
Two, for the second class of medical equipment business record personnel requirements:
1, the legal person and the person in charge of the enterprise needs to have a college degree or above, the professional does not require;
2, the person in charge of the quality of more than 3 years of work experience, college education, graduated from a related field; medical device-related professions refer to: Medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, nursing, rehabilitation, testing, management, computers and other professions
Three, for the second class of medical devices business filing materials are required:
1, the second class of medical devices business filing application form
2, a copy of the business license and organization code certificate;
3, the legal person, the organization code certificate;
3, the legal person, the organization code certificate;
5, the business license and the organization code certificate. p>3, the legal representative, the person in charge of the enterprise, the quality of the person in charge of the identification, education or title certificate copy;
4, organizational structure and departmental setup description;
5, the scope of business, the business mode description
6, the business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with the property rights) copy;
6, the business premises, the depot address, the geographical location of the map, floor plan, documents proving ownership of the house or lease agreement (with the property rights) copy. Copy of proof of ownership;
7, business facilities, equipment directory;
8, business quality management system, work procedures and other documents directory;
9, proof of authorization of the operator;
10, the basic information and functional description of the computer information management system (encouraging the second class of medical devices business enterprises to establish quality management of medical devices) Management requirements of the computer information management system, such as this, can be exempted from the description);
11, other supporting materials (such as the operation of in vitro diagnostic reagents, in vitro diagnostic reagents according to the standard requirements for the operation of the medical examiner and cold-chain facilities and equipment and other additional materials).
Four, for the specific process:
(a), first to the Industrial and Commercial Bureau for a business license, registered as an enterprise, can be a corporate enterprise, unincorporated enterprises, sole proprietorships, partnerships, etc., individual businessmen and women are not allowed to apply for the record vouchers.
(ii), and then to the Quality Supervision Bureau for the organization code certificate.
(c), and finally to the State Food and Drug Administration website with the organization code to register an account, online reporting.
(d), online reporting "medical device filing application form" need to submit electronic materials, which add * for the necessary items.
1. business license and organization code certificate copy
2. legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy
3. organizational structure and departmental setup description
4. scope of business, the business mode of description
5. business premises, warehouse address location Map, floor plan, documents proving property rights or lease agreement (with documents proving property rights)
6. Business facilities, equipment catalog
7. Business quality management system, working procedures and other documents
8. Computer information management system basic information and functional description
9. Proof of authorization of the operator
10. >10. Signed and stamped scanned application form
Legal basis
Methods for the Administration of Medical Device Business License
Article 6
Application for a Medical Device Business License shall be accompanied by the following conditions:
(1) A quality management organization or a full-time quality management personnel that is appropriate to the scale and scope of business. Full-time quality management personnel.
Quality management personnel should have a nationally recognized professional qualifications or titles;
(b) with the scale and scope of relatively independent business premises;
(c) with the scale and scope of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
(d) should be established to ensure the quality of medical equipment business license shall also have the following conditions:
(a) the quality management organization or full-time quality management personnel. p>(d) shall establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(e) shall have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
Legal basis