Drugdu.com expert's response:

The process for filing the production of Class I medical devices is as follows:

1. Corporate Qualification Preparation

Legal Business License: The enterprise must possess a valid business license, with its business scope covering the production of medical devices.

Production Conditions: Ensure that the enterprise has the necessary production conditions, including the configuration of hardware facilities such as factory premises, equipment, and personnel.

2. Product Classification Confirmation

Class I Confirmation: Confirm that the product falls under the category of Class I medical devices by referring to the "Medical Device Classification Catalog" or consulting regulatory authorities for confirmation.

Re-confirmation upon Changes: If there are changes in the product's function or intended use, re-confirm its classification to avoid misclassification.

3. Filing Document Preparation

Core Documents:

Class I Medical Device Production Filing Form

Product Technical Requirements Document: Clearly specifying performance indicators and testing methods.

Production Quality Management Documents: Demonstrating the enterprise's capability to maintain normal production standards.

Enterprise Organizational Chart and Personnel Qualification Certificates

Production Site Proof Documents: Property ownership or lease certificates.

Catalog of Main Production and Inspection Equipment

Additional Documents:

Product Inspection Report: Either self-inspection or commissioned inspection report.

Product Instructions and Label Drafts: Detailed and accurate content, avoiding exaggerated descriptions.

Compliance Declaration: Declaring that the submitted materials are true and valid, complying with relevant regulatory requirements.

4. Submission of Filing Application

Once all the required materials are prepared, submit the filing application to the municipal drug regulatory authority in the enterprise's location.

The submission method can be online or offline, depending on local policy requirements.

Some regions support online submission of electronic materials, while also requiring the preparation of paper materials for verification purposes.

5. Filing Review and Public Announcement

Formal Review: The regulatory authority conducts a formal review of the submitted materials, primarily checking for completeness and correct formatting, usually without involving on-site inspections.

Issuance of Filing Certificate and Public Announcement: Upon successful review, the regulatory authority issues a filing certificate and publicly announces the filing information on its official website.

Commencement of Production: After obtaining the filing certificate, the enterprise can officially commence the production of Class I medical devices.

6. Post-filing Management

Change Management: If any filing information (such as production address, product technical requirements, etc.) changes, the enterprise must promptly submit a change application to the original filing authority to handle the change filing.

Adverse Event Reporting: The enterprise must actively collect and report product adverse events to ensure product safety.

Compliance Operation: The enterprise should continuously comply with relevant regulatory requirements, maintain the effectiveness of its production conditions and quality management system, and accept supervision and inspections by regulatory authorities.