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Medical Device Class I Product Filing Process

I. Pre-Filing Preparation

Confirm Product Classification

Ensure the product falls within the scope of the Class I Medical Device Product Catalog or the In Vitro Diagnostic Reagent Classification Sub-Catalog.

If the product is outside these catalogs, apply to the National Medical Products Administration (NMPA) for classification determination. Filing can proceed only after confirmation as a Class I medical device.

Prepare Filing Documents

The following core materials must be submitted (subject to local regulatory requirements):

Filing Form: Completed and stamped with the enterprise’s official seal or signed by the legal representative.

Enterprise Qualification Documents:

Business license duplicate.

Legal representative’s identification.

Product Technical Documents:

Product Technical Requirements (prepared per the Guidelines for Drafting Technical Requirements for Medical Devices), specifying functional and safety indicators, as well as testing methods.

Product Inspection Report (self-tested or commissioned testing, including product information, testing basis, and results).

Instructions for Use and Label Samples (compliant with the Administrative Measures for Medical Device Instructions and Labeling),标注 (labeling) contraindications and maintenance methods.

Manufacturing Information:

Production process flowchart (identifying key processes, special processes, and production site details).

Production site proof (property ownership certificate or lease agreement; planning purpose must be non-residential).

List of major production and inspection equipment.

Quality Management System Documents: Quality manual and procedural document directory (compliant with the Good Manufacturing Practice for Medical Devices).

Declaration of Compliance: Statement confirming the product meets filing requirements, national standards, and industry standards, with a commitment to material authenticity.

Other Materials:

For overseas filers: Marketing authorization and a power of attorney for the domestic agent.

For contract manufacturing: The contractor’s qualification proof and a quality agreement.

II. Submit Filing Application

Submission Methods

Online Submission: Apply via the NMPA’s Government Service Portal or local government service platforms (e.g., Guangdong Province Government Service Network, Jiangsu Province Government Service Network).

Offline Submission: Deliver paper documents to the municipal-level medical products regulatory authority (e.g., Municipal Market Supervision Administration).

Document Review

The regulatory authority conducts a formal review. If materials are complete and compliant, the application is accepted immediately; if incomplete, a one-time notice for supplementation is issued.

III. Review and Issuance

Review Timeline

The regulatory authority completes the review within 20 working days after acceptance. If compliant, a filing certificate (electronic or paper) is issued.

For changes to filing information (e.g., product name, technical requirements), submit a modification application with supporting documents to the original filing authority.

Filing Publicity

After issuance, the regulatory authority publishes filing information on its official website. Enterprises may download the electronic filing certificate independently.

IV. Post-Filing Management

Dynamic Updates

Promptly submit modification applications for changes to filing information (e.g., production address, technical requirements).

Proactively cancel the filing if production ceases or the management category changes.

Compliance in Production

Establish a quality management system tailored to the product and ensure production conditions comply with the Good Manufacturing Practice for Medical Devices.

Regulatory authorities may conduct on-site inspections, focusing on production sites, equipment, and quality system operation.

V. Key Considerations

Material Authenticity: Filing materials must be truthful, accurate, and complete. False declarations may result in penalties (e.g., fines, revocation of the filing certificate).

Regional Variations: Different regions may have additional requirements (e.g., production site layout, environmental testing reports). Consult local regulatory authorities in advance.

Professional Assistance: Enterprises lacking filing experience may engage professional consulting firms to assist with material preparation and process optimization for improved efficiency.