Requirement for Supplementary Reply for Medical Device Registration Review

Principles for responding to notifications on supplementary reply for medical devices

1. The basic information of the supplementary reply submitted by the applicant/registrant should be consistent with the registration application materials submitted for the first time, and should correspond to the requirements of the "Medical Device Supplementary Reply Notice" and be explained separately.

2. The applicant/registrant must ensure that the content of the supplementary reply submitted is relevant to the requirements of the "Medical Device Supplementary Reply Notice" and ensure the authenticity and validity of the submitted information.

3. The applicant/registrant must ensure that the supplementary reply submitted is accurate in terms and clear in expression.

4. The process of issuing supplementary reply and returning supplementary reply only applies to the information scope submitted during this registration application, and the original application scope shall not be changed by supplementing the information.

5. If the applicant/registrant encounters a correction requirement that cannot be verified, confirmed or implemented during the reply process, the applicant/registrant should explain the reason in detail and provide scientific evidence.

Applicants/registrants should designate a person to be responsible for confirming the time limit for correction, making appointments and communications, preparing supplementary materials, etc., in order to improve the quality and efficiency of the supplementary materials. The designated person should have relevant professional knowledge and be familiar with the relevant laws, regulations and relevant review requirements for medical device registration. The applicant/registrant should try to ensure the continuity of the correction work and should not frequently change the designated person during the process.

Requirements for responding to notifications on supplementary reply for medical devices

When the applicant/registrant submits relevant supplementary information, he/she should also submit the "Supplementary Reply Contents Description" and the specific supplementary reply documents for the "Medical Device Supplementary Reply Notice".

1. Requirements for “Supplementary Reply Contents Description”

The "Supplementary Reply Contents Description" is a point-by-point explanation of all the issues in the "Medical Device Supplementary Reply Notice", which summarizes the correction ideas and supplementary reply files, explains the questions to be answered, and clarifies the names and locations of the supplementary reply files related to each issue.

(1) The applicant/registrant must explain the corresponding responses one by one according to the requirements of the "Medical Device Supplementary Reply Notice" without repeating or omitting any issues, and form a "Supplementary Reply Contents Description".

(2) The applicant/registrant must list the issues mentioned in the "Medical Device Supplementary Reply Notice" and outline how to respond to the supplementary reply request. If relevant supplementary reply is not submitted, an explanation and justification must be provided. The description of each relevant clause is recommended to include the following elements:

Briefly describe your understanding of the correction problem

Briefly describe your answering ideas or reasoning logic

The basis for the correction of the information

What objective evidence, documents, data or information are included

Description of special circumstances

(3) The “Supplementary Reply Contents Description” should clearly state the name of the supplementary reply file and its location in the “table of content of RPS”.

(4) If the change involves changes to the product technical requirements and/or instructions for use, the applicant/registrant shall provide detailed explanations under the corresponding questions in the “Supplementary Reply Contents Description”.

(5) If the applicant/registrant has other necessary supplementary documents beyond the requirements of the “Medical Device Supplementary Reply Notice”, they can describe them separately and specify the file name and location in the “Supplementary Reply Contents Description”.

2. Requirements for Supplementary Documents

(1) The applicant/registrant needs to select one of the following supplementary documents to respond based on the actual situation:

the information or data requested

Alternative information and explanation of why it would adequately resolve the issue

If the applicant/registrant believes that the supplementary reply requirements are irrelevant to the registration application or has doubts or objections to the supplementary reply requirements, they may submit relevant explanatory documents and explain the specific reasons and provide scientific evidence.

(2) Supplementary reply documents should be submitted item by item in the order of the supplementary reply requirements in the "Medical Device Supplementary Reply Notice". If multiple requirements point to the same supplementary reply document, it does not need to be submitted repeatedly and can be clearly stated in the "Supplementary Reply Contents Description".

(3) The format and signature requirements of the supplementary reply documents shall be consistent with those of the registration application documents.

(4) If necessary, it is recommended to give special markings (such as italics, bold, highlighted fonts, comparison tables, etc.) to the updated information in certain supplementary documents to highlight the changes and facilitate review.

Our analysis

Applicant/registrant = legal manufacturer

Medical Device Supplementary Reply Notice = questions by Chinese authority

Supplementary Reply Contents Description = abstract of answers by manufacturer

As in regulation mentioned even when manufacturer has no answers, try to write sound justification.

Use "Supplementary Reply Contents Description" to lead the thought of reviewer.

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