The operation of Class II medical devices need to apply for a business license and Class II medical device business record.
Procedures for business license:
(a) application for registration of establishment signed by the legal representative of the company;
(b) all shareholders to designate a representative or *** with the proxy certificate;
(c) the articles of incorporation;
(d) proof of the main qualifications of the shareholders or the identity of the natural person;
(e) ) documents containing the names and residences of the company's directors, supervisors and managers, as well as certificates of appointment, election or employment;
(vi) documents of office and proof of identity of the company's legal representatives;
(vii) notification of pre-approval of the enterprise's name;
(viii) proof of the company's domicile;
(ix) other documents required to be submitted by the State Administration for Industry and Commerce. (ix) Other documents required by the State Administration for Industry and Commerce.
The filing procedures for Class II medical device business:
(I) business license and organization code certificate copy;
(II) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity certificate, a copy of the certificate of academic qualifications or titles;
(C) organizational structure and departmental setup description;
(D) the scope of business, Business mode description;
(E) business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) a copy;
(F) business facilities, equipment directory;
(VII) business quality management system, work procedures and other documents directory;
(VIII) authorization of managers Proof;
Expanded Information:
Measures for Supervision and Administration of Medical Device Business
Article 4? In accordance with the degree of risk of medical devices, medical device business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices to implement record management, the operation of Class III medical devices to implement licensing management.
Article VII engaged in the operation of medical devices, shall have the following conditions:
(a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel shall have a nationally recognized professional qualifications or titles;
(b) with the scope of business and the scale of operation of the business and storage space; < /p>
(c) with the scope of business and the scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(d) with the operation of medical devices appropriate quality management system;
(e) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or Agree to provide technical support by the relevant organizations.
Baidu Encyclopedia - Measures for the Supervision and Management of Medical Device Businesses
Baidu Encyclopedia - Regulations of the People's Republic of China on the Registration and Administration of Companies in the People's Republic of China