Drugdu.com expert's response:

The process and requirements for filing Class I medical device products are as follows:

I. Filing Process

Determine Product Category: Confirm whether the product falls under Class I medical devices by cross-referencing with the "Class I Medical Device Product Catalog" or the "In Vitro Diagnostic Reagent Classification Catalog". Ensure that the product name, intended use, product description, etc., align with the catalog's scope. If the product is not listed in the catalog, an application for medical device classification determination must be submitted first. Once it is clarified as a Class I medical device, filing can proceed.

Prepare Filing Materials

Submit complete filing materials, including but not limited to:

Filing Form: Completed and accompanied by an electronic document, requiring the filer's signature and seal.

Safety Risk Analysis Report: Prepared in accordance with the YY 0316 standard, covering the product's intended use, hazard identification, risk control measures, and validation results.

Product Technical Requirements: Drafted in compliance with the "Guiding Principles for Drafting Technical Requirements for Medical Device Products", specifying functional and safety indicators, as well as testing methods.

Product Inspection Report: A self-inspection report or a commissioned inspection report can be submitted, which should include product information, testing basis, and results.

Clinical Evaluation Data: Detailed description of the product's intended use, target population, contraindications, usage environment, and records of adverse events for similar products.

Instructions and Label Specimens: Compliant with the "Regulations on the Management of Medical Device Instructions and Labels", highlighting key information such as contraindications, maintenance methods, and production dates.

Production and Manufacturing Information: An overview of the production process, including key processes, special processes, and production site conditions.

Supporting Documents: For domestic enterprises, a copy of the business license is required; for foreign enterprises, marketing authorization certificates and a power of attorney from the domestic agent are necessary.

Conformity Declaration: A statement declaring that the product complies with filing requirements, national standards, and industry standards, along with a commitment to the authenticity of the materials.

Power of Attorney: Required if the filing is not handled by the legal representative.

Submit Filing Application: Submit the application online through the "Medical Device Registration Management Information System" and simultaneously submit the paper materials to the municipal regulatory authority.

Review and Filing: The regulatory authority reviews the submitted materials. If the materials are complete and meet the requirements, filing is completed on the spot. If the materials are incomplete, the applicant is informed of the necessary supplements all at once.

Changes and Reissuance: For changes to the filing information, a change description and relevant supporting documents must be submitted. If the filing certificate is lost, an application for reissuance can be made.

II. Precautions

Material Completeness: Ensure that all filing materials are complete and comply with the format requirements for filing materials. Supporting documents (such as business licenses and organization code certificates) must be valid. Consistency in filling out the same items across the application materials is required.

Production Site and Quality Management: The filer must establish a quality management system appropriate for the product and maintain its effective operation. The production and manufacturing information must clearly outline site conditions and process descriptions. If production is entrusted to another party, the qualification certificate of the entrusted party and a quality agreement must be provided.

Technical Requirements and Clinical Evaluation: The product technical requirements are a core document for filing and must include functional and safety indicators, as well as testing methods. The clinical evaluation data must provide a detailed description of the product's intended use, target population, contraindications, usage environment, and records of adverse events for similar products.

Labels and Instructions: The instructions and labels must comply with the "Regulations on the Management of Medical Device Instructions and Labels", highlighting key information such as contraindications, maintenance methods, and production dates.

Subsequent Supervision: After filing, the regulatory authority may conduct retrospective checks on the filing materials. If the filing materials are found to be non-compliant, the filer will be ordered to make corrections within a specified time frame. Failure to comply with the correction requirements will result in the cancellation of the filing being publicly announced.