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CMD Blogs

Twenty Industry Standards Issued in One Day

Twenty newly-established or revised industry standards were released by NMPA on February 19, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Full List Industry mandatory

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NMPA Roundup February 2024

Here’s the latest China NMPA 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

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Medical Device GSP

Medical Device GSP Announced

NMPA released “Quality Management Measures for Medical Device Operations”, on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted. By the end of November

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NMPA: Four IVD Guidelines Issued

NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process. Significance of Guidelines The guidelines

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