Solicit opinions | Medical device registrant of Guangdong food and Drug Administration Administrative regulations on extended inspection of recorders

       In order to implement the drug administration of Guangdong Province Some measures on optimizing the registration, review and approval of class II medical devices Requirements of,Further improve the quality of medical device review and approval,Establish a more scientific and efficient review and approval system,Reduce duplicate inspection Repeated evaluation,Facilitate medical device manufacturers to choose raw materials,Simplify registration and declaration,According to the National Drug Administration Announcement on registration items of medical device master document  2021Year36number Relevant regulations,The matters related to the implementation of class II medical device master document registration are hereby notified as follows:

one Applicable scope of master document

Medical device master document is a form of technical data,This kind of data is used to authorize the medical device registration applicant to use it as a part of the registration application data when applying for medical device registration.

The master document of medical devices is applicable to class II medical devices proposed by the medical device registration applicant of our province Including in vitro diagnostic reagent Issuance of registration certificate Application for change of registration.

two Master document registration requirements

Medical device master file registration is voluntary,Guidance for medical device registration applicant Assist the master document owner to establish the master document according to the relevant requirements of medical device registration application materials.Domestic master document owners can apply for registration by themselves,Import Including Hong Kong, Macao and Taiwan The owner of the master document shall entrust a domestic agency to apply for registration.The owner of the master document or its agent applies for the digital authentication certificate used in the registration and declaration system CA after,Submit the registration data of the medical device master file in the electronic declaration system.

   three Requirements for master documents

The main documents of medical devices include specific technical contents,For example, the raw material master document includes the description of raw material composition Physical performance research data Chemical performance research data Biological evaluation data/Toxicological risk analysis data, etc.The technical content of the master document shall refer to medical devices/In vitro diagnostic reagent registration application data requirements and relevant guiding principles,See the attachment for registration data requirements1.For the contents clearly required to be submitted in the medical device application materials,Not applicable to submission in the form of master document.

When the contents of the registered medical device master document change,The owner of the master document can apply for updating the registration data,Including changes in authorization Changes in the agency and any changes in the master documentation.To update the relevant data, a complete set of updated master documents shall be submitted,It is also attached with the description of changes in the contents of the previous version of the main document.

   four Master document information disclosure

After the master document registration data is submitted successfully,The system sends the medical device master document registration receipt to the master document owner or its agent (see attachment)2 .The registration receipt only proves that the main document is archived for reference,For reference of medical device product registration and other declaration matters.The provincial bureau is responsible for establishing the registration database of medical device master documents,And will publish the master document and register relevant information on the official website in due time (see attachment)3 ,For public enquiries.

   five Related review of main documents

Upon receipt of the application for registration of associated medical devices, the evaluation department of the provincial Bureau can refer to the corresponding main documents for combined evaluation. If the evaluation does not meet the requirements of associated use, the registration applicant should supplement and submit relevant evaluation materials.

    This is to inform you.

Attachment:

1. Requirements for registration of master documents of medical devices

2. Receipt of master document registration of medical devices

3. Relevant information of medical device master document registration

Guangdong Drug Administration

On August 4, 2022

Attachment 1

Medical device Master document registration data requirements

Attachment 2

Medical device master document registration receipt

Attachment 3

Medical device master document registration related information