Drugdu.com expert's response:

 

Class I medical devices do not require a license for business operations, but if production or specific sales activities are involved, a filing certificate is required. The specific application process is as follows:

I. Filing Requirements for Business Operations of Class I Medical Devices

Situations Requiring No License or Filing

If an enterprise is solely engaged in the sales of Class I medical devices (without involvement in production), it only needs to explicitly include "sales of Class I medical devices" in its business scope on the business license, without the need for additional licenses or filings.

Situations Requiring Filing

Product Filing: If an enterprise sells self-produced Class I medical devices, it needs to submit filing materials to the local municipal drug regulatory authority (drug administration bureau) before the product is marketed, in order to obtain a "Filing Certificate for Class I Medical Devices".

Production Filing: If an enterprise produces Class I medical devices on its own, it needs to submit production filing materials to the municipal drug administration bureau to obtain a "Production Filing Certificate for Class I Medical Devices".

II. Materials Required for Filing

(I) Materials for Product Filing

Basic Documents

"Filing Form for Class I Medical Devices" (filled out online, printed, and stamped with the official seal and signed by the legal representative).

A copy of the business license (stamped with the official seal).

A copy of the legal representative's identity document (stamped with the official seal).

Product Technical Documents

Product technical requirements (clearly specifying performance indicators and testing methods, which must comply with national or industry standards).

Product inspection reports (either self-inspected or commissioned for inspection, covering all indicators specified in the technical requirements).

Clinical evaluation materials (if the product meets the conditions for exemption from clinical evaluation, submission can be waived; otherwise, clinical trial reports or clinical usage literature for similar products must be provided).

Labels and Instructions

Design drafts of product instructions and labels for the smallest sales unit (must comply with the "Regulations on the Instructions and Labels of Medical Devices", clearly stating usage methods, precautions, contraindications, etc., and must not contain misleading terms such as "treatment" or "cure").

Photos of the product and its packaging (some regions require photos of the actual product).

Risk and Compliance Documents

Product risk analysis materials (assess potential risks such as design defects and misuse, and formulate risk control measures).

Safety risk analysis reports (analyze in detail potential safety risks of the product, such as electrical safety and biocompatibility, and propose preventive measures).

Compliance statement (declare that the product complies with classification requirements and current standards, and guarantee the authenticity of the submitted materials).

(II) Materials for Production Filing

Enterprise Qualification Documents

"Production Filing Form for Class I Medical Devices".

A copy of the business license (stamped with the official seal).

A copy of the product filing certificate (if the enterprise produces its own products).

Production Condition Documents

Production site proof (a copy of the property certificate or lease contract, clearly stating the production address and area).

A list of production equipment and inspection instruments (indicating model, specification, and quantity).

Process flowcharts (for non-active medical devices, key and special processes must be clearly specified; for active medical devices, the production process must be described).

Personnel and Quality Documents

Copies of the identity documents, academic certificates, and professional title certificates of the production, quality, and technical supervisors.

A list of the academic qualifications of production management and quality inspection personnel (indicating their departments and positions).

Quality management system documents (including quality manuals, procedure documents, etc., covering the entire production process, such as procurement, production, inspection, and storage).

III. Application Process

Confirm Product Classification

Confirm that the product belongs to Class I according to the "Catalog of Class I Medical Devices". If there is any doubt about the classification, apply to the drug administration bureau for classification determination.

Prepare Filing Materials

Prepare all the required materials in accordance with the above requirements, ensuring that the materials are complete, authentic, and compliant.

Submit Filing Application

Submission Method: Submit the materials through the local government service platform (such as online filing supported by some provinces) or at an offline counter.

Review Time: The drug administration bureau will complete a formal review on the spot or within 5 working days.

Obtain Filing Certificate

After the materials are complete and meet the requirements, the drug administration bureau will issue a "Filing Certificate for Class I Medical Devices" (with no expiration date, but changes in filing information must be promptly updated).
If the production filing materials meet the conditions, the drug administration bureau will issue a "Production Filing Certificate for Class I Medical Devices" on the spot.

IV. Key Considerations

Classification Accuracy

Strictly refer to the "Catalog of Class I Medical Devices" to avoid misclassifying Class II or Class III products as Class I (e.g., some dressings and surgical instruments may belong to Class II).

Product Technical Requirements

The technical requirements must not be lower than national or industry standards. If there are no national or industry standards for the product, it must be self-formulated and verified.

Compliance of Labels and Instructions

Labels and instructions must not contain misleading terms such as "treatment" or "cure", and must clearly indicate "Class I Medical Device" and the filing number.

Post-filing Changes

Changes in key information such as product name, technical requirements, and production address require submission of change filings.
Other information changes can be updated by the enterprise itself.

Cross-provincial Sales

Product filings are valid nationwide and do not require repeated filings; however, production filings must be handled at the municipal drug administration bureau where the production is located.

V. Subsequent Regulatory Requirements

Annual Self-inspection Report: Production enterprises are required to submit an annual self-inspection report on the operation of their quality management systems (some provinces and cities have simplified requirements).

Information Disclosure: Filing information must be publicly disclosed on the official website of the drug administration bureau for public supervision.

Supervision and Inspection: The drug administration bureau will conduct不定期 (irregular) spot checks on production conditions, compliance of labels and instructions, etc., to ensure compliance with filing requirements.

By editor