State Food and Drug Administration | Announcement on the issuance of technical guidelines for compliance with the basic principles of safety and performance of medical devices,ZOOP

State Food and Drug Administration | Announcement on the issuance of technical guidelines for compliance with the basic principles of safety and performance of medical devices

time： 2022/07/16

State Food and Drug Administration | Announcement on the issuance of technical guidelines for compliance with the basic principles of safety and performance of medical devices

2022Year29number

To establish a scientific medical device supervision system,Speed up international integration,2020year3month,Equivalent transformation in ChinaIMDRFThird Edition Basic principles of safety and performance of medical devices hereinafter referred to as basic principle . basic principle It is the basic requirements for safety and effectiveness of medical devices extracted based on general risks,The registration applicant shall consciously perform the subject responsibility,take basic principle It is required to be integrated into the R & D and production process of medical devices,Under the control of the quality management system,Form corresponding evidence of conformity,At the time of registration, it shall be submitted as the declaration materials to prove that the product is safe and effective.

In order to further guide the registration applicant to use it scientifically and rationally basic principle Conduct product R & D and registration application,Ensure the safety and effectiveness of medical devices,Based on the current cognitive level and the actual situation of the review work, the center for device review of the State Food and Drug Administration,Organized the preparation of <Basic principles of safety and performance of medical devices>Compliance technical guide ,It is hereby issued.

It is hereby notified that:.

enclosure

1.Basic principles of safety and performance of medical devices - Technical Guidelines for compliance

2.Basic principles of safety and performance of medical devices - Technical Guidelines for compliance - instructions for use

State Drug Administration

Medical device technical evaluation center

2022year7month12day

Annex I

Basic principles of safety and performance of medical devices - Technical Guidelines for compliance

Annex II

Basic principles of safety and performance of medical devices - Technical Guidelines for compliance - instructions for use

Medical devices are directly related to people's life and health, Administrative measures for registration and filing of medical devices Order of the State Administration of market supervision and Administration Section47number Article 13 stipulates: Medical device registration The filing shall comply with relevant laws statute rules Mandatory standards,Follow the basic principles of safety and performance of medical devices,Refer to relevant technical guidelines,Certificate registration Safety of registered medical devices Effective Controllable quality,Ensure the authenticity of the whole process information accuracy Complete and traceable. 2020year3month,Issued by the State Drug Administration Basic principles of safety and performance of medical devices hereinafter referred to as basic principle It is the basic requirements for safety and effectiveness of medical devices extracted based on general risks,It is an important basis for technical review and decision-making.

In order to further guide the registration applicant to use it scientifically and rationally basic principle ,take basic principle To integrate the requirements of high quality into the product development and production process,To ensure the safety and effectiveness of medical device products,And on this basis,Accurately fill in the List of basic principles for safety and performance of medical devices ,The Audit Center organizes the review of relevant laws and regulations Standards, guiding principles and other documents,Combined with technical review requirements,Compiled Basic principles of safety and performance of medical devices - Technical Guidelines for compliance hereinafter referred to as guide . guide It is a general requirement for all medical devices,The relevant use methods are described as follows:

one Judge applicability,Determine the method used to prove compliance

The registration applicant shall combine the product characteristics,according to guide in Applicable products Column,determine basic principle Applicability of specific requirements.For applicable requirements:,During product development,Priority can be given to the guide Methods used to prove compliance Available for reference given in the column,s%s121s%s9s%s,s%s s%s s%s.

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