Drugdu.com expert's response:

I. Basic Eligibility for Applicants

To apply for medical device export qualification approval in China, the applicant must be a domestic medical device registrant, filing entity, or a manufacturer that has obtained the Medical Device Production License or completed production filing. Its registered business address must fall within the administrative jurisdiction of the approving authority. Applications will be rejected if the enterprise is under ordered rectification for production suspension, included in the serious illegal and dishonest list, or the relevant product is under ongoing investigation.

II. Document Requirements for Two Types of Export Qualifications

For medical devices that have completed registration or filing in China, the required documents include the corresponding Medical Device Registration Certificate or product filing record, the supporting Medical Device Production License or production filing record, and valid documents proving the product's legal sales status.
For export-specific medical devices that have not completed domestic registration or filing, in addition to the basic production qualification documents, the applicant must also provide self-certification materials proving that the production conditions comply with the Medical Device GMP specifications, as well as complete product technical requirements to ensure full-process quality control during production.

III. Core Approval Rules and Processing Timeline

For products that have completed domestic registration and filing, the approval only involves compliance review of submitted documents, and the qualification certificate can be issued within ‌1 working day‌. For export-specific products without domestic registration or filing, the application must first go through preliminary review by the local market supervision and administration department, with a total processing period of ‌5 working days‌ — this duration excludes the time required for mandatory on-site inspection and subsequent enterprise rectification.
When applying for the second type of export qualification, on-site inspection will be mandatory if the submitted documents contain ambiguous information, unresolved issues from past product sampling inspections, or the enterprise's quality management system is rated at Risk Level 4. The approval process can only resume after the production conditions are verified to be compliant.
The validity period of the final export qualification certificate will not exceed the earliest expiration date of all submitted supporting documents. For Class I medical devices, the maximum validity period of the export qualification certificate is ‌3 years‌.

IV. Supporting Qualification Requirements for Foreign Trade Scenarios

Completing China's domestic export qualification approval is only the first step. To smoothly enter the target overseas market, the product must also meet the local medical device registration and certification requirements of the importing country, such as CE certification for the EU market and FDA registration for the US market. These corresponding qualification documents must be fully prepared with the products, and provided to local regulatory authorities and cooperative clients during customs clearance and overseas sales.
At present, most regions in China support full online processing of this qualification approval. The issued electronic Export Sales Certificate has the same legal validity as the paper version, and can be directly used for foreign trade business communication and overseas customs clearance.