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2026 China NMPA Bluebook is here:
Here is our summary of our successful study with China GMP’s support. Guide a US manufacturer with 5 global sites to comply with China GMP Objectives Key Activities Recommended Areas
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
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
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
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 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 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