Nine Guidelines for Medical Devices

2020-03-15

On March 10, 2020, NMPA released nine guidelines for medical device in order to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. All the new guidelines and their links are listed in the table below. Bradynuoen suggest manufactures to follow the new requirements to do relevant registration. info@inspirativemed.com

Guideline Name	Link
Guidelines for Technical Review of Registration of X-ray Image Guidance Systems for Radiotherapy	http://www.nmpa.gov.cn/WS04/CL2138/375518.html
Guidelines for Technical Review of Registration of PET/CT	http://www.nmpa.gov.cn/WS04/CL2138/375518.html
Guidelines for Technical Review of Registration of Implantable Left Ventricular Support System	http://www.nmpa.gov.cn/WS04/CL2138/375519.html
Guidelines for Technical Review of Registration of Hair Removal Diode Laser System	http://www.nmpa.gov.cn/WS04/CL2138/375520.html
Basic Principles of Medical Device Safety and Performance	http://www.nmpa.gov.cn/WS04/CL2138/375521.html
Guidelines for Technical Review of Registration of EBV Nucleic Acid Assay Reagent	http://www.nmpa.gov.cn/WS04/CL2138/375522.html
Guidelines for Technical Review of Registration of HBV HBeAg and HBeAb Assay Reagent	http://www.nmpa.gov.cn/WS04/CL2138/375522.html
Guidelines for Technical Review of Registration of Thalassemia-related DNA Assay Reagent	http://www.nmpa.gov.cn/WS04/CL2138/375522.html
Guidelines for Technical Review of Registration of HBV Resistance-related DNA Mutation Assay Reagent	http://www.nmpa.gov.cn/WS04/CL2138/375522.html