【Policy and Regulation】Interpretation of Requirements for Renewal Registration Application Materials (Active, Passive)
No.1: Chapter Table of Contents
The table of contents should include the directory of the submitted application materials, encompassing all the headings and subheadings of this chapter. It should specify the directory serial number, directory title, applicability, name of the uploaded file, and page numbers of the uploaded file, and indicate the page numbers of each content in the directory. For applicability, it should clearly state whether the CR directory is applicable.
No. 2: Application Form
Fill in the application form (including authorization letter) according to the filling requirements
No. 3: Contact information before declaration and past communication records with regulatory authorities
- During the validity period of the registration certificate, if the registrant has communicated with the regulatory authority in the form of a meeting regarding the declared product, the following contents shall be provided (if applicable):(1) List the communication status of the regulatory authority’s responses.(2) In communication, the questions clearly raised by the registrant and the suggestions provided by the regulatory authority.(3) Explain how to solve the above problems in this application.2. If not applicable, it shall be clearly stated that there have been no previous declarations and/or pre-declaration communications for the declared product within the validity period of the registration certificate.
No.4: Standard List and Conformity Declaration
If new mandatory standards for medical devices are issued and implemented during the validity period of a medical device registration certificate, and the changes made to the registered product to comply with the new mandatory standards require a change in registration, the registrant shall submit copies of the change registration (filing) documents and their attachments that have been approved by the original approval authority before applying for renewal of registration.
No.5: Statement on Authenticity and Accuracy
Declaration by the registration applicant ensuring the authenticity of the submitted materials.
No.6: Conformity Declaration
Declaration by the registration applicant: 1. The product for renewal of registration complies with the requirements of the Measures for the Administration of Medical Device Registration and Filing and relevant regulations.2. The products for renewal of registration shall comply with the classification requirements specified in the “Classification Rules for Medical Devices”.
No.7: Other Regulatory Information
1. Submit copies of the original medical device registration certificate and its attachments, as well as copies of all previous medical device change registration (filing) documents and their attachments.2. There are no changes to the products for renewed registration. If a product has changes other than those specified in the registration certificate, it shall be clearly stated that “the changes to the product are controlled through the quality management system, and there are no changes to the matters specified in the registration certificate.”
No.8: Chapter Table of Contents
The table of contents should include the directory of the submitted application materials, encompassing all the headings and subheadings of this chapter. It should specify the directory serial number, directory title, applicable situation, name of the uploaded file, and page numbers of the uploaded file, and indicate the page numbers of each content in the directory. The applicable situation should clearly state whether the CR directory is applicable.
No.9: Declaration Summary
There are no changes to the products with renewed registration. If a product has changes other than those specified in the registration certificate, it shall be clearly stated that “the changes to the product are controlled through the quality management system, and there are no changes to the matters specified in the registration certificate.”
No.10: Chapter Directory
The chapter table of contents should include the table of contents of the submitted application materials, covering all headings and subheadings of this chapter. It should specify the serial number of the contents, the title of the contents, the applicable situation, the name of the uploaded file, and the page numbers of the uploaded file, and indicate the page numbers of each content in the table of contents. For the applicable situation, it should be specified whether the CR directory is applicable.
No. 11: Product Technical Requirements
If there are changes involving the product technical requirements within the validity period of the original medical device registration certificate, the product technical requirements revised in accordance with the change registration (filing) documents shall be submitted.
No.12: Non-clinical Research
For matters specified in the original medical device registration certificate that require continued completion and involve non-clinical studies, a relevant summary report shall be provided, along with corresponding materials.
No.13: Other Materials
For matters specified in the original medical device registration certificate that require continued completion and involve non-clinical studies, a relevant summary report shall be provided, along with corresponding materials.
No.14: Chapter Table of Contents
The table of contents should include the directory of the submitted application materials, covering all headings and subheadings of this chapter. It should specify the directory serial number, directory title, applicable situation, name of the uploaded file, and page numbers of the uploaded file, and indicate the page numbers of each content in the directory. The applicable situation should clearly state whether the CR directory is applicable.
For matters specified in the original medical device registration certificate that require continued completion, if they involve clinical evaluation, a relevant summary report shall be provided, along with corresponding materials.
No.15: Clinical Evaluation Data
For matters specified in the original medical device registration certificate that require continued completion, if they involve clinical evaluation, a relevant summary report shall be provided, along with corresponding materials.
The table of contents should include the directory of the submitted application materials, covering all headings and subheadings of this chapter. It should specify the directory serial number, directory title, applicable situation, name of the uploaded file, and page numbers of the uploaded file, and indicate the page numbers of each content in the directory. The applicable situation should clearly state whether the CR directory is applicable.
Source: Beijing Municipal Drug Administration
Translated by Bradyknows
