Legal analysis: 1, medical device products export sales certificate:
Medical device products sales certificate is approved by the Food and Drug Administration, for the medical device export trade enterprises, for such documents required materials are probably: a copy of the business license, medical device products export sales certificate registration form, a copy of the medical device product registration certificate A copy of the medical device production license and a commitment to the authenticity of the material.
2, the corresponding business or production qualifications:
If a business development and operation of Class II medical devices, you need to apply for Class II medical device company business record, Class III medical devices for medical devices for business license, and for improving the production of technical enterprises to export, you need to apply for the corresponding medical device registration certificate and production license according to the type of medical devices in China. License, which is the main export of medical equipment products can prove the necessary preconditions for the sale of goods.
3, the right to import and export business:
The right to import and export business refers to the import and export enterprises to carry out import and export business qualification, apply for the right to import and export business enterprises only in the city of Commerce Bureau, Inspection and Quarantine Bureau, the electronic port, the downtown Customs and other relevant departments of the approval of the approval of various types of certificates in the above departments, the enterprise is the real right to have the right to import and export, you can Engaged in import and export business.
Legal basis: "Medical Device Registration and Record Management Measures" Article 3 Medical device registration refers to the applicant for registration of medical devices (hereinafter referred to as the applicant) in accordance with legal procedures and requirements for medical device registration applications, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, efficacy and quality control and other reviews, to decide whether or not to agree with the activities of its application.
Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management department to submit the record information, drug supervision and management department of the filing of information submitted for the record of the activities of the archives.