Drugdu.com expert's response:

The medical device production filing is only applicable to the production activities of ‌Class I Medical Devices‌. Applications shall be submitted to the municipal drug regulatory department with districts where the enterprise is located, and the filing certificate can be issued on the spot if the conditions are met.
The production of Class II and Class III medical devices does not apply to the filing system. It is required to apply for the official Medical Device Production License from the provincial drug regulatory department.

I. Pre-application Preparation Requirements

‌Personnel Requirements‌: It is required to appoint qualified quality principals, technical principals, and at least 2 full-time inspectors. Personnel in relevant positions shall have a technical secondary school degree or above in medical device-related majors, and the personnel in other positions can be flexibly configured according to the actual situation of the enterprise.

‌Site & Facilities‌: The nature of the production site shall be non-residential, and the area shall match the scale of the products to be produced. If producing sterile medical devices or in vitro diagnostic reagents that require air purification, a qualified test report of the clean room shall be additionally provided.

‌System Documents‌: Establish a quality management system covering the whole production process, including complete documents such as production process flow charts and product inspection procedures.

‌Pre-qualification‌: The Class I Medical Device Filing Certificate for the products to be produced must be obtained before submitting the production filing application, otherwise the filing information cannot be entered into the system.

II. List of Core Application Materials

Class I Medical Device Production Filing Form

Copy of the enterprise business license

Copy of the obtained product filing certificate

Property right or lease certification documents of the production site

List of main production equipment and testing instruments

Catalogue of quality management systems

Compliance statement for the authenticity of all submitted materials

III. Complete Application Process

The enterprise completes internal self-inspection to confirm that personnel, site and system documents all meet the regulatory requirements.

Submit electronic application materials online, and prepare the printed documents with official seals at the same time.

The local municipal drug regulatory department checks the completeness of the materials on the spot, and accepts the application directly if it meets the requirements.

After the review is passed, the Class I Medical Device Production Filing Certificate will be issued on the spot, and the relevant filing information will be publicly displayed on the official website of the drug regulatory department.

IV. Post-application Management Requirements

When the information specified in the filing certificate, such as enterprise name, production address and product scope, changes, it is required to submit a change description to the original filing department in time to complete the change filing.

For enterprises that set up multiple production sites across different districts and cities, they need to go through separate filings with the municipal drug regulatory department corresponding to each production site.

Those who fail to file as required or submit false materials will be fined not less than 10,000 yuan but not more than 30,000 yuan in accordance with relevant regulations.