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2025 China NMPA Bluebook is here:
China’s Greater Bay Area is one of the most affluent and populated regions with close to 86.17M people, more than the entire size of Germany. To sell in GBA Hong
The NMPA published three new clinical guidelines on August 6, 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Three New Published Clinical Guidelines To
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2023. These updates are presented by China Med Device, LLC, your partner
The NMPA published the final version of “Clinical Evaluation Exempt Catalog for Medical Devices” on July 20, 2023, which includes 2025 medical devices. Implementing risk-based clinical evaluation, the catalog will
The NMPA published 30 guidelines in July 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. For English copies of any guidelines below, please email
The NMPA released the “Guideline on Continuous Glucose Monitoring System” on July 18, 2023. It is the finalized version from the draft issued in September 2022. Highlights of the Guideline
The NMPA Medical Device Standardization Administration issued the “Second Batch of Medical Device Classification Results for 2023” on July 13. The document identifies 71 Class III, 80 Class II and
The NMPA published four guidelines for AI software on July 10, 2023, propelling China to be the leader in the AI applications. Full List of Guidelines for AI Software The
The NMPA published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023, to direct related manufacturers for type testing, clinical evaluation, and regulatory submission.
The NMPA published 14 guidelines on July 6, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. For English version of any guidelines below, please
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2023. These updates are presented by China Med Device, LLC, your partner
The NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Standards Industry mandatory standards are