Drugdu.com expert's response:

To apply for the certificate of record-filing for online sales of medical devices, the following steps are typically involved:

Preparation of Qualifications: Firstly, the medical device online sales enterprise needs to ensure compliance with relevant regulations and requirements, including business licenses, medical device operation permits, etc.

Application for Record-filing: Submit the record-filing application to the relevant regulatory authority, which is usually the National Medical Products Administration (NMPA) or local drug regulatory department. The application needs to include basic information about the enterprise, information about the sales platform, types and quantities of medical devices sold, and other relevant information.

Record-filing Review: The regulatory authority will review the record-filing application. The review process typically includes assessing whether the sales platform meets requirements and whether the medical devices sold comply with regulatory standards.

Issuance of Certificate: If the record-filing application passes the review, the regulatory authority will issue the certificate of record-filing for online sales of medical devices. This certificate usually includes information such as the record-filing number and validity period.

Ongoing Supervision: Medical device online sales enterprises holding the record-filing certificate need to comply with relevant regulations and requirements and accept supervision and inspection from the regulatory authority.