NMPA published Registration Guideline on Novel Coronavirus (Covid-19) Antigen/Antibody Detection Reagent on February 25, addressing the urgent needs of virus diagnostics. It is the second major regulation after theGuideline on Coronavirus Nucleic Acid Detection Reagentpublished on Feb 12.
NMPA Guideline on Coronavirus Nucleic Acid Detection Reagent NMPA published Registration Guideline on Novel Coronavirus Nucleic Acid Detection Reagent on Jan 12th, addressing the urgent needs of virus diagnostics. Accelerated Approval After issue of the Emergency Approval&nbs
Publication No. 国家标准名称 Standard Title 1 GB 19083-2010 医用防护口罩技术要求 Technical requirements for protective face mask for medical use View Document Online
List of China National Standards Related to Pandemic Prevention Product 1. 医用防护产品相关国家标准 National Standards Related to Medical Protective Products 领域 Area 标准编号 Publication number 标准名称 Standard Title
NMPA published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. Please see the summary below: Application Area The guideline is appli
As the Spring Festival of 2020 passes, Let's go back through 2019, Take a look at the time to write down that weighty report 02/2019 Appointed as Guangdong Food&Drug Technolog for Evaluation and Certification standing director unit Guangdong food&drug technology for evalu
Policies New Clinical Exemptions for 148 Devices and 23 IVDs Forty Class III devices were added as exemptions to the Clinical Trial Exemptions Catalog for Medical Devices, which NMPA released on December 20, 2019. This final version also added exemptions for 108 Class II devices and 23 IVDs (o
