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2026 China NMPA Bluebook is here:
October 12, 2020 — Hainan Province, China. This real-world data study of China clinical evaluation in the Hainan pilot zone will help urgent need medical
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 issued a notice today to delay the UDI implementation date. The first batch of medical devices have changed from October 1st, 2020 to January
Last year, NMPA issued a number of UDI related policies regarding the UDI implementation. There is a UDI database portal (https://udi.nmpa.gov.cn) established which includes sections
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