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2026 China NMPA Bluebook is here:
Under China’s regulatory framework for medical devices, innovative neurosurgical devices, due to their technical complexity and high application risks, must undergo stringent approval processes. This
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
The NMPA Medical Device Standardization Administration issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268
The NMPA granted innovation approval to Boston Scientific Neuromodulation’s DBS directional lead and issued a review report on November 6. The published review reports like
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2024. These updates are presented by China
The NMPA released the “Announcement on Further Clarifying Matters Related to the Domestic Production of Imported Medical Devices in China (Draft)” on November 4, 2024.
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