【EXPERT Q&A】What materials should be submitted for the registration of Class III medical devices within the country?

May 14, 2025  Source: drugdu 78

Drugdu.com expert's response:

 

The registration of domestic Class III medical device products in China requires the submission of application materials to the National Medical Products Administration (NMPA). Specifically, the process is handled through its subsidiary, the Center for Medical Device Evaluation (CMDE), which is responsible for the technical review of medical device product registrations. Below is a detailed explanation:

I. Submission Authority

The registration materials for domestic Class III medical device products must be submitted to the National Medical Products Administration (NMPA). As the competent authority overseeing medical device regulation in China, the NMPA is responsible for the registration approval, quality supervision, and market regulation of medical devices. The Center for Medical Device Evaluation (CMDE), a subsidiary of the NMPA, specifically undertakes the technical review of medical device product registrations.

II. Submission Process

Preparation of Registration Materials

Applicants must prepare a complete set of registration application materials in accordance with the relevant regulations and guidance principles issued by the NMPA. These materials typically include, but are not limited to: Medical Device Registration Application Form; Supporting documents (e.g., business license, organization code certificate, etc.); List of Basic Requirements for Medical Device Safety and Effectiveness; Summary materials (including product description, model/specification, packaging instructions, intended use, contraindications, etc.); Research data (e.g., product performance studies, biocompatibility evaluations, shelf-life and packaging studies, etc.); Manufacturing information (e.g., description of the production process, production site, etc.); Clinical evaluation materials (e.g., clinical trial reports, clinical literature, etc.); Product risk analysis materials; Product technical requirements; Product registration inspection report (including the registration inspection report and pre-evaluation opinion); Instructions for use and label samples; Declaration of conformity, etc.

Online Submission of Application

Applicants must submit the registration application materials through the NMPA's designated online platform (e.g., the Medical Device Registration e-Reporting Information System). When submitting, applicants must ensure the authenticity and completeness of the materials and fill in the relevant information as required by the platform.

Review and Rectification of Materials

Upon receipt of the application materials, the CMDE will conduct a formal review and technical evaluation. If any deficiencies or non-compliance with requirements are found in the materials, the applicant will be notified to make rectifications. The applicant must complete the rectifications within the specified time frame and resubmit the materials.

Approval and Issuance of Certificate

If the evaluation confirms that the requirements are met, the NMPA will make a decision to grant registration and issue a Medical Device Registration Certificate. The validity period of the registration certificate is typically five years. For renewal of the registration certificate upon expiration, the applicant must submit an application for renewal to the original registration authority no later than six months before the expiration date.

III. Key Considerations

Compliance with Regulations: Applicants must closely monitor the latest regulations and guidance principles issued by the NMPA to ensure that the registration application materials comply with the most recent requirements.

Authenticity of Materials: Applicants should ensure that the submitted registration application materials are true, accurate, and complete, with no false records, misleading statements, or material omissions.

Time Management: Given that the registration process may involve multiple stages and a considerable amount of time, applicants should plan their schedules reasonably to ensure that all preparatory work is completed within the specified time frames.

"/

By editor
Share: 

your submission has already been received.

OK

Subscribe

Please enter a valid Email address!

Submit

The most relevant industry news & insight will be sent to you every two weeks.