Cosmetic Contact Lenses belongs to the third category of medical devices, and needs to apply for a company business license and a medical device business license.
Handling business license procedures:
1. Application for Company Registration (Filing).
2. Articles of Association (signed by all shareholders for a limited liability company and by all promoters for a joint stock limited company).
3. The qualification certificates of shareholders and promoters or the identity certificates of natural persons.
4. Employment documents of the legal representative, directors, supervisors and managers.
according to the provisions of the company law and the articles of association, a limited liability company shall submit the shareholders' decision or the resolution of the shareholders' meeting, and a joint stock limited company that initiated the establishment shall submit the minutes of the shareholders' meeting (a joint stock limited company that raised the establishment shall submit the minutes of the founding meeting). Where the Company Law and the Articles of Association stipulate that the appointment of personnel in the company's organizational structure must be made by the board of directors and the board of supervisors, relevant materials such as resolutions of the board of directors signed by directors and resolutions of the board of supervisors signed by supervisors shall also be submitted.
5. Certificate of residence use.
6. A joint stock limited company established by offering shall submit a capital verification certificate issued by a legally established capital verification institution. Where the initial contribution made by the promoters is non-monetary property, the supporting documents that have gone through the formalities for the transfer of property rights shall be submitted.
7. A joint stock limited company established by offering shares for public offering shall submit the approval documents of the securities regulatory authority of the State Council.
8. Laws, administrative regulations and decisions of the State Council stipulate that the establishment of a company must report the approved items in the business scope or the company's application for registration, and submit copies of relevant approval documents or licenses before registration.
Go through the formalities of medical device business license:
1. Application Form for Medical Device Business License;
2. Certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce;
3. A copy of the ID card, education or professional title certificate and resume of the quality management personnel of the proposed enterprise;
4. Organization and functions of the proposed enterprise;
5. A copy of the registered address of the proposed enterprise, the geographical location map and floor plan (indicating the area) of the warehouse address, and the property right certificate (or lease agreement) of the house;
6. Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise;
7. business scope of the proposed enterprise.
Extended information:
Measures for the administration of medical device business license
Conditions for applying for a medical device business license
Article 6 To apply for a medical device business license, the following conditions shall be met at the same time:
(1) Having a quality management institution or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) It has a relatively independent business place suitable for its business scale and business scope;
(3) Having storage conditions suitable for the business scale and scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
(4) A product quality management system shall be established and improved, including procurement, incoming goods acceptance, warehousing, outbound review, quality tracking system and adverse event reporting system;
(5) It shall have the ability of technical training and after-sales service suitable for the medical device products it deals in, or agree to provide technical support by a third party.
References:
Baidu Encyclopedia-Measures for the Administration of Medical Device Business License
Baidu Encyclopedia-Regulations of the People's Republic of China on the Administration of Company Registration.