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Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2021. These updates are presented by China Med
Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the
The NMPA issued a notice “Interpretation of Regulations on Self-test of Medical Device Registration” on October 27, 2021, explaining the self-test report guideline in details.
Hainan NMPA published “Guideline for Importation of Urgently Needed Drugs and Medical Devices in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone”
One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with detailed guidebook on how to self-test. After two
The NMPA issued the “Notice regarding implementation of Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures”
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med
The published the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents Listed in Catalog of Clinical Trial Exemption” and “Clinical Guideline for In Vitro Diagnostic
The NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for
The NMPA granted Innovation Approval to three medical devices in September 2021: Dental implant surgery navigation and positioning equipment Ultrasonic diagnostic equipment for endoscope Transcatheter
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423