Drugdu.com expert's response:

The registration materials for domestically manufactured active medical device products need to meet various requirements, as detailed below:

I. Basic Document Requirements

Table of Contents: It should include all main and sub-headings, indicate the page numbers for each content in the table, and clarify applicability (e.g., whether the CR table of contents is applicable).

Glossary of Terms and Abbreviations: Define terms or abbreviations that require clarification based on the actual situation of the registration application materials.

Application Form: Fill out and upload the application form with a unified approval code exported from the application system (including the power of attorney), in accordance with the form-filling requirements.

Product List: List the model numbers, specifications, structures and components, and accessories of the proposed products in tabular form, along with the identification (such as model or part numbers, unique device identifiers, etc.) and descriptive explanations (such as dimensions, materials, etc.) for each model and specification.

II. Quality Management System and Certification Documents

Domestic Applicants: Submit a copy of the business license or institutional legal person certificate.

Innovative Medical Devices: For domestically manufactured medical devices approved under the "Special Review Procedure for Innovative Medical Devices," relevant certification documents proving passage of the innovative medical device review should be submitted.

Emergency Approval Medical Devices: For medical device products approved under the "Medical Device Emergency Approval Procedure," relevant certification documents proving passage of the emergency approval should be submitted.

Rapid Review and Approval: For medical devices approved under the "Beijing Municipal Medical Device Rapid Review and Approval Measures," relevant explanations conforming to the review and approval measures should be submitted.

Contract Manufacturing: If another enterprise is commissioned for production, provide the资格文件 (qualification documents, such as a copy of the business license) of the contracted enterprise, along with the委托合同 (contract manufacturing agreement) and quality agreement.

III. Pre-Submission Communication and Previous Records

Pre-Submission Contact Information: If, prior to product submission, the registration applicant has communicated with the regulatory authority regarding the proposed product in a meeting format, or if the proposed product is related to previous registration submissions, provide the regulatory authority's response to the pre-submission communication, the受理号 (acceptance number) of the previously registered product, and relevant materials from previous pre-submission communications (such as information submitted prior to previous submission meetings, meeting agendas, presentation slides, final meeting minutes, responses to pending items from the meeting, and all emails related to the application).

Previous Submission Declaration: If not applicable, explicitly declare that the proposed product has no previous submissions and/or pre-submission communications.

IV. Standards and Conformity Declarations

Standard List and Conformity Declaration: The registration applicant declares that the proposed product complies with current national and industry standards and provides a list of compliant standards.

Authenticity and Accuracy Declaration: The registration applicant provides a declaration guaranteeing the authenticity of the submitted materials.

Conformity Declaration: The registration applicant declares that the proposed product complies with the requirements of the "Medical Device Registration and Filing Management Measures" and relevant regulations, as well as the classification requirements of the "Medical Device Classification Rules."

V. Priority Review Applications (if applicable)

National Science and Technology Major Projects: Provide an explanation and relevant supporting materials (such as project task documents) for medical devices included in national science and technology major projects, national key research and development plans, or municipal major science and technology projects and科技创新行动计划 (science and technology innovation action plans).

Rare Disease Treatment: For medical devices that diagnose or treat rare diseases and have significant clinical advantages, provide incidence data and relevant supporting materials for the product's indications, supporting materials proving that the indications belong to rare diseases, a summary of the current clinical treatment status for the indications, and an explanation with relevant supporting materials demonstrating that the product has significant clinical advantages over existing products or treatment methods.

Elderly Disease Treatment: For medical devices that diagnose or treat diseases specific to or prevalent among the elderly and for which there are currently no effective diagnostic or treatment methods, provide supporting materials proving that the product's indications belong to diseases specific to or prevalent among the elderly, a summary of the current clinical treatment status for the indications, and an explanation with relevant supporting materials stating that there are currently no effective diagnostic or treatment methods.

Pediatric-Specific Medical Devices: For medical devices specifically designed for children and with significant clinical advantages, provide supporting materials proving that the product's indications belong to pediatric diseases, a summary of the current clinical treatment status for the indications, and an explanation with relevant supporting materials demonstrating that the product is specifically designed for diagnosing or treating pediatric diseases and has significant clinical advantages over existing products or treatment methods.

Clinically Urently Needed Medical Devices: For medical devices that are clinically urgently needed and for which no same-variety products have been approved for registration in China, provide a summary of the current clinical treatment status for the product's indications (explaining the reasons for clinical urgency), information on the approval and clinical use of the product and similar products overseas, and a search statement proving that no same-variety products have been approved for registration in China and that there are currently no equivalent alternative diagnostic or treatment methods.