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2024 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 article, using three specific examples—neurosurgical
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 regulatory submissions. Significance of Compliance
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 IVD reagents. It is the
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 this one serve as important
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 submitted by December 3, 2024.
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 Med Device, LLC, your partner
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. Feedbacks need to be submitted
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 in Clinical Pediatrics, the scope
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 of overseas on-site inspections of
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 regulatory submissions. Significance of Compliance
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 partner in Chinese market access.
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 important references for you to
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