China Internatioan Medical Equipment Exhibitbion 2024
CMEH 2024
CMEH 2024
Shenzhen World Exhibition & Convention Center
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/11481for specific inquiries.
