The second class of medical sales online filing process?
The online filing process of Class II medical devices:
Application for Class II medical device business filing should be submitted:
1, business license;
2, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, certificate of qualifications or titles;
3, organizational structure and departmental setup instructions;
< p>4, business scope, business mode description;5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights of housing or lease agreement; (with documents proving property rights of housing)
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, to encourage the Use of computer information management system;
9, proof of authorization of the operator;
10, signed and stamped scanned application form;
11, other supporting materials.
What information is required for the filing of Class II medical device business?
The required information is as follows:
To apply for the "Class II Medical Device Business Record Certificate" and want to successfully pass the Drug Inspection Bureau of the audit, which is the key to the three parts: the 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 the relevant professional;
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, working 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 no such, 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).
Apply for Class II medical device business record?
1, the legal representative of the enterprise, the person in charge of the enterprise, quality management personnel should be no "supervision and management of medical devices regulations" Article 40 of the circumstances.
2, the enterprise should have with the scale and scope of operation of the quality management organization or full-time quality management personnel.
3, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
4, should be in accordance with relevant national and local regulations, the establishment of a sound and necessary quality management system, and strictly enforced.
5, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
How long is the audit period for Class II medical device business filing?
The second class business filing very quickly, in accordance with the City Council online guide to do a good job of information, go to the City Council to hand in the information, in line with the case of the certificate will be given on the spot, followed by a month will be verified.
I am a self-employed person, how to apply for Class II medical device business record certificate?
China's 1987 publication and implementation of the General Principles of Civil Law will be individual business households and rural contractors are categorized as citizens (natural persons), rather than enterprises. 2014 implementation of the "supervision and management of medical devices regulations" and "supervision and management of medical equipment business approach" clearly stipulates that: engaged in the operation of the second and third class of medical devices, by the business enterprise to the municipal level of the location of the district Food and drug supervision and management department for the record or apply for a business license.
Therefore, the new applicant to engage in the second, third class medical device business applicants should be in accordance with the law in the industrial and commercial sector registered enterprises. The original individual businessman's medical device business license to apply for change or expiration of the continuation, can be in accordance with the 2014 revision of the "Individual Businessman Regulations" Article 29 of the provisions of the application for change to the form of business organization, to the location of the municipal food and drug supervision department for the record or apply for a permit to operate.
If they are not transformed into an enterprise organizational form, they will no longer be able to operate medical devices.
Measures for Quality Management of Medical Device Business
Article XII engaged in the operation of Class II medical devices, the business enterprise shall be filed with the municipal food and drug supervision and management department of the location of the district, fill in the Class II medical device business filing form, and submit the information provided for in Article 8 of the Measures (except for the eighth item).
Article VIII engaged in the third class of medical equipment business, the business enterprise shall apply to the municipal food and drug supervision and management department of the district in which the location, and submit the following information:
(a) a copy of the business license and organization code certificate;
(b) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the identification, education, or proof of professional title Copies;
(C) organizational structure and departmental setup instructions;
(D) business scope, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with documents proving ownership of the house) copies;
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other documents directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.