Category: NMPA (CFDA) Updates

Here’s the latest China NMPA regulatory and clinical affairs news in September 2020 for medical device and IVDs pros. These updates are presented by China

NMPA published the final notice “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” on September 25, 2020. The draft version was released

NMPA issued nine September guidelines that cover indications of orthopedic, cardiovascular, hematology, general hospital, etc. General NMPA Guidelines September Technical guideline on medical device cybersecurity

In the third quarter of 2020, the NMPA posted recall notices regarding 26 medical devices and IVDs. Here we provide the analysis of the recalls.

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

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

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

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

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

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

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

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