Year: 2020

As innovative devices and first-of-kind products enter the China market, the NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical

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

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

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

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

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)

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

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

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

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