China Association for Medical Devices Industry (CAMDI) - A Total of 500 Guiding Principles Documents for Medical Device Registration Review have been Released in China!

With the release of Announcement No. 40 [2022] of the Center for Medical Device Evaluation, NMPA (hereinafter referred to as the “CMDE”), Guiding Principles for Review of Registration of Clinical Evaluations of Gene Sequencers, on November 22, 2022, the number of guiding principles documents for medical device registration review (hereinafter referred to as the guiding principles documents) has reached 500 since the first one was released in 2007. They comprehensively play a guiding role in registration applications and technical reviews from multiple angles, marking a new step in China’s guiding principles documents system, the formation of new tools for medical device safety and effectiveness evaluations, and a firm scientific foundation for technical reviews by the CMDE.

Summary of Titles of 500 Guiding Principles Documents

S/N	Document name	Released by	Released on
1	Guidelines for Biological Evaluation and Review of Medical Devices	NMPA	2007/6/15
2	Guiding Principles for Writing Registration Application Data of Drug-Containing Medical Device Products	National Medical Products Administration	2009/2/20
3	Guiding Principles for Technical Review of Registration of Gastric Tube Products	National Medical Products Administration	2009/3/18
4	Guiding Principles for Technical Review of Registration of Tracheal Intubation Products	National Medical Products Administration	2009/3/18
5	Guiding Principles for Registration Application Data of Passive Implantable Medical Device Products	National Medical Products Administration	2009/12/30
6	Guiding Principles for Registration Application Data of Blood-glucose Monitoring Systems for Self-testing	National Medical Products Administration	2010/10/18
7	Guiding Principles for Technical Review of Registration of Breast Implant Products	National Medical Products Administration	2011/3/24
8	Guiding Principles for Technical Review of Registration of Contact Lens Care Products	National Medical Products Administration	2011/3/24
9	Guiding Principles for Technical Review of Virus Inactivation Process Verification for Allograft Medical Devices	National Medical Products Administration	2011/3/24
10	Guidelines on Technical Reviews of Production Registration of Disposable Infusion Instrument	National Medical Products Administration	2011/3/24
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491	Guiding Principles for Review of Registration of Disposable EEG Electrodes	CMDE	2022/9/15
492	Guiding Principles for Review of Preclinical Registration of Human Immunodeficiency Virus Antigen/Antibody Detection Reagents	CMDE	2022/9/28
493	Guiding Principles for Review of Registration of EB Virus Antibody Detection Reagents	CMDE	2022/9/28
494	Guiding Principles for Review of Registration of Analytical Performance Assessments of In Vitro Diagnostic Reagents for Qualitative Detection	CMDE	2022/9/28
495	Guiding Principles for Review of Registration of Reference Interval Determination of In Vitro Diagnostic Reagents	CMDE	2022/9/28
496	Guiding Principles for Review of Registration of Control Materials - Research on Assigning Values to Control Materials	CMDE	2022/9/28
497	Guiding Principles for Review of Registration of Hepatitis E Virus IgM IgG Antibody Detection Reagents	CMDE	2022/9/28
498	Guiding Principles for Review of Registration of Additively Manufactured Interbody Fusion Cages	CMDE	2022/11/3
499	Principles for Clinical Trials of In Vitro Diagnostic Reagents with Human Biobank Samples	CMDE	2022/11/22
500	Guiding Principles for Review of Registration of Clinical Evaluations of Gene Sequencers	CMDE	2022/11/22
501	Guiding Principles for Review of Registration of Clinical Trials of Microsatellite Instability (MSI) Detection Reagents	CMDE	2022/11/22

*The table is excerpted. Please click on the link: http://www.camdi.org/news/11481 for specific inquiries.

A Total of 500 Guiding Principles Documents for Medical Device Registration Review have been Released in China!

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