Procedures and standards for export certificates
A medical device product export sales certificate is divided into two formats according to whether the product has obtained medical device registration certificate.
For products that have obtained the medical device registration certificate, the main content of the export sales certificate is: the product meets the relevant standards of the Chinese People's Republic of China*** and the country, has been registered in China, is authorized to be sold in the Chinese market, the export is not subject to restrictions.
For products that have not obtained a medical device product registration certificate, the main content of its export sales certificate: the product is not registered in China, has not yet entered the Chinese market, but exports are not restricted.
Two, the medical device export sales certificate is valid for two years.
Third, the applicant for the certificate of export sales of medical device products can be a manufacturer or exporter.
Four, has obtained a medical device registration certificate of the product, apply for medical device products export sales certificate, should fill out the application form and submit the following documents:
(a) the exported product producer's "Medical Device Manufacturer's License" (a copy)
(b) the exported product's "Medical Device Registration Certificate" (copy)
(c) ) Business License of the exporting enterprise (copy)
(d) Self-assurance statement of the applicant to ensure that the exported product meets the regulatory requirements of the drug supervision and management authorities for the production and registration of the product, and that the submitted materials are true and lawful.
Copies of the submitted certificates should be stamped with the official seal of the enterprise to which the certificate belongs.
Fifth, did not obtain a medical device product registration certificate of the product, apply for a medical device product export sales certificate, should fill out the application form (format see Annex 3), and submit the following documents:
(a) the manufacturer's business license (copy)
(b) the business license of the exporting company (copy)
(c) the applicant's self-assurance Declaration to ensure that the submitted materials are true and legal.
Copies of the submitted certificates should be stamped with the official seal of the enterprise to which the certificate belongs.
VI. Medical exporters should ensure that the exported products meet the export requirements, and all legal responsibilities incurred in the export process shall be borne by the exporters themselves.
VII, medical device products export sales certificate for the working time limit of 15 working days.
VIII, the provisions of this regulation shall come into force on the date of publication.