1. Certificate of export sales of medical device products:
The sales license of medical device products is approved by the food and drug supervision and administration department, and is aimed at medical device export trading enterprises. The materials required for handling such certificates are probably: a copy of the business license of the enterprise, a registration form of the export sales certificate of medical device products, a copy of the registration certificate of medical device products, a copy of the production license of medical devices, and a letter of commitment on the authenticity of materials.
2, the corresponding enterprise or production qualification:
Enterprises that develop and operate Class II medical devices need to apply for the business record of Class II medical device companies, and Class III medical devices need to apply for business licenses. In order to improve the export of production technology enterprises, it is necessary to apply for the corresponding medical device registration certificate and production license according to the types of medical devices in China, which is a necessary prerequisite for handling the sales of major export commodities of medical device products.
3. Right to operate import and export:
The right to operate import and export refers to the qualification of import and export enterprises to carry out import and export business. Enterprises applying for the right to operate import and export can engage in import and export business only after being approved by the Municipal Bureau of Commerce, Inspection and Quarantine Bureau, electronic port, urban customs and other relevant departments and obtaining various certificates recognized by the above departments.
Legal basis:
Measures for the Administration of Registration and Filing of Medical Devices Article 3 The registration of medical devices refers to the activities in which an applicant for registration of medical devices (hereinafter referred to as the applicant) submits an application for registration of medical devices in accordance with legal procedures and requirements, and the pharmaceutical supervisory and administrative department reviews its safety, effectiveness and quality controllability on the basis of scientific cognition according to laws and regulations, and decides whether to approve its application.
Medical device filing refers to the activities that medical device filers (hereinafter referred to as filers) submit filing materials to the pharmaceutical supervisory and administrative departments in accordance with legal procedures and requirements, and the pharmaceutical supervisory and administrative departments file the submitted filing materials for future reference.