Drugdu.com expert's response:

The materials required for applying for a medical device registration certificate cover multiple aspects, including enterprise qualifications, product technology, quality control, clinical evaluation, and compliance declarations. The specifics are as follows:

Application Form: Fill out the Medical Device Registration Application Form, ensuring that the information is accurate and complete. It should cover basic product information, the registration applicant, and the intended use of the product, among other details.

Proof Documents:

Copies of the business license and organization code certificate (newly registered enterprises may use the unified social credit code instead and may not need to provide the organization code certificate separately) to prove the legal operation of the enterprise.

Identity proofs and copies of educational or professional qualification certificates for the legal representative, enterprise leader, and quality leader to confirm the identities and qualifications of key enterprise personnel.

A list of technical personnel along with copies of their identity cards, educational certificates, and professional qualification certificates to demonstrate the capabilities of the team.

Product Technical Documents:

Product Technical Requirements: These should be formulated based on relevant standards and literature, reflecting technical content such as performance indicators of the product, including the basis for determining technical indicators or main performance requirements.

Product Inspection Report: Issued by a qualified inspection institution to prove that the product quality meets the specified requirements. It can be a self-inspection report from the filer or a product registration inspection report issued by a medical device testing institution. For medical devices requiring clinical trials, an inspection report from within six months prior to the start of the clinical trial should be submitted; for those not requiring clinical trials, an inspection report from within one year prior to registration acceptance should be submitted.

Product Instructions and Design Drafts of Labels for the Smallest Sales Unit: The instructions and labels should comply with the relevant requirements of the "Regulations on Medical Device Instructions and Labels," clearly and accurately describing key information such as the product's functions, intended uses, usage methods, and precautions.

Production Manufacturing Information: An overview of the production process, including key and special processes. For example, proof documents for the production site, and if there are special production environment requirements, copies of facility and environment proof documents should also be submitted; generally, this includes copies of the house property certificate or lease agreement and the lessor's property certificate, a general layout plan of the factory area, and a layout plan of the main production workshops; a list of main production equipment and inspection instruments, etc.

Clinical Evaluation Documents: For products requiring clinical trials, corresponding clinical evaluation documents, including clinical trial protocols and clinical trial reports, should be provided to verify the safety and effectiveness of the product.

Quality Management System Documents: These include quality manuals, procedural documents, and work instructions, among others, to prove that the enterprise has established a quality management system that complies with regulatory requirements, such as a quality system assessment report, a medical device production quality management specification inspection report, or a medical device quality system certification certificate.

Compliance Declaration: A declaration stating that the product complies with relevant regulations and standards, such as a declaration of compliance with medical device registration requirements, the classification requirements for this product and the basis for such classification, compliance with current national and industry standards, and a list of standards that are met, as well as a statement on the authenticity of the submitted registration materials.

Other Documents:

If another enterprise is entrusted for production, the entrusted enterprise's qualification documents (copies of the business license), the entrustment contract, and the quality agreement should also be provided.

For overseas medical device registration applications, the overseas filer's enterprise qualification proof documents, a power of attorney for the designated agent within China, the agent's commitment letter, and a copy of the agent's business license, as well as Chinese translations of the instructions and labels for imported products, etc., should also be provided.

For specific products, trial documents, valid proof documents of production quality system assessment (certification), a statement of self-assurance regarding authenticity, etc., may also be required.