How to apply for the Medical Device Export Sales Certificate?

Medical EquipmentThe Product Export Sales Certificate is an approval document issued by the Drug Administration according to the application of enterprises within its jurisdiction for enterprises that meet the requirements. This certificate aims to facilitate the export of medical device products within its jurisdiction and is an important service item. The following will introduce the handling process and relevant precautions of the Medical Device Export Sales Certificate.

The provincial Food and Drug Administration where the enterprise is located is responsible for managing the handling of medical device product export sales certificates within its administrative region. Enterprises need to submit applications to this department and provide corresponding materials and information as required. The handling process includes application, review, and certificate issuance. Enterprises applying for the Medical Device Product Export Sales Certificate should operate in accordance with the specified procedures.

Enterprises that meet the following conditions can apply for the Medical Device Product Export Sales Certificate:

Enterprises that have obtained medical device product registration certificates and production license certificates;

Enterprises that have completed medical device product filing and production filing.

The Food and Drug Administration will issue relevant certification documents for eligible manufacturing enterprises to support the export sales of their medical device products.

When applying for the Medical Device Product Export Sales Certificate from the local provincial Food and Drug Administration or its designated department, enterprises should submit the following materials:

A copy of the enterprise business license;

A copy of the medical device production license or filing certificate;

A copy of the medical device product registration certificate or filing certificate;

A guarantee statement by the applicant on the authenticity of the application materials.

It should be noted that when an enterprise applies for the Medical Device Product Export Sales Certificate, if its production does not meet relevant regulatory requirements, the enterprises credit rating is low, or it is in the period of production rectification or involved in cases, the certificate will not be issued.

Can an export sales certificate be obtained without valid registration and license certificates?
According to relevant regulations, only manufacturing enterprises holding valid registration certificates/product filing certificates and license certificates/filing certificates can handle the medical device product export sales certificate.

What should I do if I cant log in after user registration?
Users must use the legal person login account. If you are a foreign national, please call 12345 for further assistance.

How to query the handling results?
Enterprises can query the handling progress and results at the declaration terminal and can download the official electronic documents by themselves.

What is the processing time limit?
The processing time limit for the medical device product export sales certificate is 15 working days.

The validity period of the medical device product export sales certificate should not exceed the earliest expiration date of various certificates submitted by the enterprise in the application materials, and should not exceed 2 years at most.

When the relevant materials submitted by the enterprise change, it should promptly report to the certificate - issuing department.

Enterprises should establish and keep export product files, including medical device product export sales certificates, medical device export filing forms, purchase contracts, quality requirements, inspection reports, certificates of conformity, packaging, label styles, customs declarations, etc., to ensure the traceability of the product export process.

Enterprises should ensure that export products meet the relevant regulations for medical device exports and the relevant requirements of the importing country.

The above is an introduction to the handling process, application conditions, required materials, frequently asked questions, and other precautions of the medical device export sales certificate. When handling this certificate, enterprises should comply with relevant regulatory requirements and prepare the required documents and materials according to the actual situation. For detailed handling processes and requirements, please refer to relevant regulations and official notices.