Drugdu.com expert's response:

 

To ensure the authenticity and completeness of application materials, the following procedures and requirements must be followed when applying for classification determination of medical devices:

I. Application Methods and Channels

1. Online Registration and Application

Visit the official website of the National Institutes for Food and Drug Control (NIFDC, under the National Medical Products Administration) at https://www.nifdc.org.cn. Navigate to the "Medical Device Standards and Classification Management" section and click on the "Medical Device Classification Determination Information System."

Register an account, complete the Application Form for Classification Determination of Medical Devices, and upload other required materials.

Starting from February 19, 2024, paper submissions are no longer required; the entire process is conducted electronically.

2. Paper Submission (Backup Option)

If paper materials are required, print the Application Form for Classification Determination online, affix the enterprise's paging seal to all documents, and mail them to the following addresses based on product type:

Domestic Products: Provincial drug regulatory authorities.

Imported, Hong Kong, Macao, and Taiwan Products: National Medical Products Administration Medical Device Standards Management Center (Address: Room B404, Building 4, No. 31 Huatuo Road, Bio-Pharmaceutical Industrial Base, Daxing District, Beijing).

II. Application Documentation Requirements

1. Basic Materials

Application Form for Classification Determination

Signed and stamped by the legal representative or responsible person; if the enterprise is unregistered, provide documents such as the Enterprise Name Pre-Approval Notice, signed by the proposed legal representative with the date noted.

Complete all fields, including product name, intended use, structural composition, and working principle. Avoid vague terms like "etc." or "see attachments."

Product Photos or Videos

Provide实物 (physical product) photos demonstrating usage, internal/external packaging, and typical models/specifications (if multiple models exist).

Product Technical Requirements

Prepared in accordance with the Guidelines for Drafting Technical Requirements for Medical Devices, including performance indicators and testing methods.

Product Instructions

The version intended for market release, compliant with the Regulations on Medical Device Instructions and Labeling.

Declaration of Material Authenticity

A statement confirming the submitted materials are true, complete, and valid, with legal liability assumed.

2. Additional Materials for New Products (if applicable)

Comparative Analysis with Similar Products: Compare with marketed products, entries in the Classification Catalog, or classification determination notices to demonstrate compliance with criteria for newly developed products not listed in the catalog.

Clinical Application Value Evidence: Provide academic papers, monographs, or literature reviews published in core journals to prove clinical value.

Innovation Description: Outline the product's innovative features and potential impact.

Novelty Search Report: Issued by an information or patent search agency to verify novelty.

Other Supporting Materials: Such as patent certificates or clinical trial data.

3. Power of Attorney (if applicable)

Submit a Power of Attorney if the applicant is not the legal representative or responsible person.

III. Documentation Specifications

1. Format and Binding

Use A4-sized paper; government documents should be provided in their original dimensions.

Ensure copies are legible, dated, and stamped with the official seal.

Maintain a left margin >20mm for archival binding.

2. Content Consistency

Ensure uniformity across all documents to avoid conflicts.

Key information (e.g., product name, intended use) must align with instructions, technical requirements, and other materials.

3. Language Requirements

All materials must be in Chinese; foreign-language documents require translated versions and originals.

IV. Application Process and Timelines

1. Submission and Formal Review

The review center completes a formal review within 10 working days of receipt (excluding receipt and mailing periods).

If materials are incomplete, a notice for supplementation will be issued, requiring a one-time submission within 30 working days;逾期 (overdue) submissions will be rejected.

2. Technical Review and Determination

The review center organizes expert evaluations and may request additional information.

Upon completion, results are communicated to the applicant and synchronized with the classification determination information system.

3. Result Inquiry and Follow-Up Actions

Applicants can track application status and results via the system.

If the product is classified as a specific category of medical device, proceed with registration or filing as required.

V. Key Considerations

1. Policy Updates

The Medical Device Classification Catalog may undergo dynamic adjustments (e.g., new categories for AI-assisted imaging diagnostics and biodegradable hemostatic materials in 2024). Stay informed of policy changes.

2. Compliance Recommendations

Maintain internal classification records, noting determination bases and risk points.

Integrate classification considerations early in the R&D phase to avoid project delays or compliance risks due to misclassification.

3. Dispute Resolution

If disagreeing with classification results, communicate with the notifying authority or resubmit after improving materials.

By editor