Drugdu.com expert's response:

The registration application for Class II medical devices in China requires a range of materials covering multiple aspects to ensure the safety, effectiveness, and quality controllability of the products. Below are the main materials and their detailed descriptions:

I. Basic Application Documents

Medical Device Registration Application Form:

It must be signed by the legal representative or person in charge and stamped with the official seal.

All items filled in should be complete and accurate, consistent with the subsequent materials submitted.

Usually, two copies are required, with one copy not bound and provided separately.

Medical Device Manufacturer Qualification Certificate:

Includes a copy of the "Medical Device Manufacturing License" and a copy of the "Business License".

The product applying for registration should fall within the production scope specified in the "Medical Device Manufacturing License".

Both the "Medical Device Manufacturing License" and the "Business License" must be valid.

II. Product Technical Documents

Product Technical Report:

It should include at least the product characteristics, working principle, structural composition, and intended use.

The basis for determining the product's technical indicators or main performance requirements.

The product design control, development, and research process.

The main process flow and description of the product.

Product testing and clinical trial situations.

Comparative analysis with similar products at home and abroad.

Product Technical Requirements:

Clearly specify the main technical indicators or performance requirements of the product.

They must comply with relevant national standards, industry standards, or registered product standards.

Applicable Product Standards and Descriptions:

If national or industry standards are adopted as the applicable product standards, the text of the adopted national or industry standards should be submitted.

The registered product standard should be signed and stamped by the manufacturer, along with a declaration of compliance with the standard.

III. Product Safety and Effectiveness Documents

Safety Risk Analysis Report:

Compiled in accordance with the requirements of the "Medical Device Risk Analysis" standard.

It should include risk analysis in areas such as energy hazards, biological hazards, environmental hazards, hazards related to use, and hazards caused by functional failure, inadequate maintenance, and aging.

Corresponding risk control and prevention measures should be proposed.

Product Inspection Report:

It can be a self-inspection report by the medical device registration applicant or filer, or an inspection report issued by a qualified medical device inspection institution.

The inspection report should comply with the requirements of the State Drug Administration.

For medical devices requiring clinical trials, an inspection report issued by a medical device testing institution within six months before the start of the clinical trial should be submitted.

For medical devices not requiring clinical trials, an inspection report issued by a medical device testing institution within one year before registration acceptance should be submitted.

Clinical Evaluation Materials:

Submit corresponding clinical trial materials or clinical trial materials of similar products based on whether the product requires clinical trials.

Clinical trial materials should include clinical trial contracts, clinical trial protocols, and clinical trial reports.

If the product falls within the scope of the "List of Medical Devices Exempt from Clinical Evaluation," a comparative description with the listed products should be submitted to prove basic equivalence.

IV. Product Description and Quality Documents

Medical Device Instructions:

They should comply with the "Regulations on the Instructions, Labels, and Packaging Marks of Medical Devices."

The instructions should be provided and stamped with the official seal of the manufacturer.

The instructions should include the generic name, model, and specification of the product, the name and domicile of the manufacturer, the production address and contact information, the number of the product technical requirements, the production date and expiration date or shelf life, product performance, main structure, intended use, contraindications, precautions, and other content that needs to be warned or prompted, installation and use instructions or illustrations, maintenance and upkeep methods, special storage conditions and methods, and other content that should be indicated as required by the product technical requirements.

Valid Certification Documents for Product Production Quality System Assessment (Certification):

Includes a quality system assessment report signed and stamped by the provincial (food and drug) regulatory authority and within the validity period.

A medical device production quality management specification inspection report or a medical device quality system certification certificate.

If the state has implemented production implementation rules, submit an inspection and acceptance report for the implementation rules.

V. Other Necessary Documents

Self-Declaration of the Authenticity of Submitted Materials:

Includes a list of submitted materials and a commitment by the manufacturer to assume legal responsibility.

It must be signed by the legal representative or person in charge and stamped with the official seal of the enterprise.

Power of Attorney (if applicable):

If the applicant is not the legal representative or person in charge themselves, a "Power of Attorney" must be submitted.

Documents Related to Registration Changes (if applicable for registration changes):

If applying for a registration change, submit documents related to the change items, such as changed product technical requirements, inspection reports, and instructions.

The original medical device registration certificate and its appendix (copy) must also be submitted.