What is needed for the filing of Class II medical devices?
1. A copy of business license and organization code certificate. (If the company is not yet registered on the first company registration process, do a good company license and then do the Class II medical device business filing certificate can be)
2. Legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of a copy of the certificate of qualifications or professional title. (Conditions are not met, it's okay, looking for lean)
3. Organizational structure and departmental setup description. (If not, please contact us)
4. Description of business scope and mode of operation. (If not, please contact us)
5. Business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy. (If not, please contact us)
6. Business facilities, equipment catalog.
7. Catalog of business quality management system, work procedures and other documents.
8. Proof of authorization of the operator.
9. Other supporting materials.
What information is required for the filing of Class II medical device business?
The required information is as follows:
Apply for the "Class II Medical Device Business Record Certificate" and want to successfully pass the Drug Administration's audit, which is the key to three parts: registered address, personnel requirements, related materials.
The second class of medical equipment business record on the registered address requirements:
1, office area of not less than 50 square meters;
2, warehouse area of not less than 50 square meters; (including in vitro diagnostic reagents need to be refrigerated warehouses)
3, including disposable consumables, if the requirements of the office address and the warehouse together with the area of not less than 150 square meters
Note: business premises and warehouses shall not be set up in residential housing
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 the need to have more than 3 years of experience, college education, graduated from a related field;
Medical device related professional refers to: medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, nursing, rehabilitation, testing, management, computers and other professions
The second class of medical devices business filing material requirements:
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 representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy;
4, organization and departmental setup description;
5, the scope of business, the business mode of 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) copy of House ownership documents) copies;
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 a computer information management system in line with the requirements of the quality management of medical equipment) Business quality 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 of the application for the operation of the medical examiner and cold-chain facilities and equipment and other additional materials).