One, the agent of Beijing medical equipment class II filing, three types of approval application and acceptance
Enterprises should submit the following application materials in accordance with the scope of acceptance:
1. "Medical Device Business License Application Form";
2. Business license, organization code certificate Copy; (submit the original)
3. Legal representative, the person in charge of the enterprise, the person in charge of quality, a copy of identification, proof of education or title; (submit the original)
4. Description of the organizational structure and departmental setup;
5. Proof of the property rights of the business premises, warehouses, and the right to use the premises; if the storage is entrusted, a copy of a written agreement with the commissioning party to sign the Written agreement, a copy of the commissioner's business license for medical equipment and records in the form of a copy of the form of storage and distribution services provided by other medical device manufacturers and operators should be submitted;
6. Directory of business facilities and equipment;
7. Directory of management, quality management system, work procedures and other documents;
8. Introduction to the basic information of the computer information management system and description of functions
9. The applicant is not the legal representative or person in charge, should be submitted to the power of attorney;
10. Self-assurance of the authenticity of the declared materials, and a commitment to the declaration of the material is not true to bear legal responsibility.