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2026 China NMPA Bluebook is here:
The NMPA Center for Medical Device Evaluation (CMDE) published an article on pediatric In vitro diagnostic (IVD) on October 21, 2024. According to the definition
The NMPA released the results of two overseas inspections on October 8, 2024, which revealed noncompliance in two South Korean manufacturers. This marked the resumption
Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
The NMPA granted innovation approvals to CryoLife, Inc’s BioGlue Surgical Adhesive and issued a review report. The published review reports like this one serve as
The NMPA CMDE (Center of Medical Device Evaluation) published the “Clinical Trial Design Types Recommendations for Non-active Implantable Devices, Neurological and Cardiovascular Surgical Devices, Dental
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
NMPA Center for Medical Device Standardization Administration Issued the draft national standard “Post-Market Surveillance for Medical Device Manufacturers” on July 19, 2024, for feedback. Feedback
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted
To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and
On August 28, 2024, the NMPA released the “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment).”