2020
September 30, 2020
NMPA issued a notice today to delay the UDI implementation date for the first batch of medical devices from October 1st, 2020 to January 1st, 2021. The notice adjusted both […]
September 29, 2020
NMPA published two Q&A on orthopedic devices, addressing two frequently asked issues: Q: How to determine the mechanical performance indicators when submitting the orthopedic product technical requirements (PTR), and what […]
September 25, 2020
NMPA published “Draft Technical Guideline on Medical Device Cybersecurity” on September 8, 2020. Feedbacks need to be submitted to NMPA by October 19, 2020. It is the second version after […]
September 22, 2020
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in August 2020. These updates are presented by China Med Device, LLC, your partner in […]
September 18, 2020
Hainan government published “The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”, unveiling first-of-its-kind policies on permission to import drugs […]
September 9, 2020
NMPA published seven pathology and clinical chemistry guidelines in August, to direct manufacturers for clinical trial, local type testing and regulatory approval: Clinical trial guideline on anti-tumor companion diagnostics (CDx) […]
September 7, 2020
NMPA granted Innovation Approvals of two diabetic retinopathy (DR) assistant diagnosis software, to Shenzhen Guiji and Shanghai Yingtong. It is the first time that AI technology is approved for ophthalmology […]
September 3, 2020
NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take […]
August 31, 2020
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging (MRI) System Comparing the Similar Device (draft)” on August 13, 2020. The 19-page document provides manufacturers detailed pathway for clinical […]
August 21, 2020
Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros for July 2020. These updates are presented by China Med Device, LLC, your partner in […]
August 18, 2020
NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues: Q: When applying for an in vitro diagnostic equipment registration change, is it necessary to […]