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Tag: China Med Device

NMPA Roundup April 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2024. These updates are presented by...

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21 Class III Devices Exempted for Clinical Trial: Faster Market Access for Surgical Equipment in Cardio, Neuro, Ortho, Aesthetic and Dental Applications

NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose...

NMPA Roundup March 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2024. These updates are presented by...

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,...

Covidien Recalls 188 Nonabsorbable Suture in China

Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the...

NMPA Roundup December 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2023. These updates are presented by...

Four Draft Clinical Guidelines Issued in One Day

NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024. For an English copy of any...

Navigating the Future: Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and Anticipating the 14th CIMDR in 2024

As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...

NMPA Roundup October 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by...

NMPA Inspection: Importation Halted Due to Address Discrepancies

The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses. NMPA organized a remote inspection of XVIVO Perfusion...

NMPA: Fifty-four Draft Guidelines Issued in One Day

NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines...

NMPA Roundup September 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in September 2023. These updates are presented by...

RWD in China: Study Design and Statistical Analysis Guideline Propels Hainan to be World Leader

Picture: Grace Palma, CEO of China Med Device, LLC in RWD workshop in Hainan NMPA published the “Guideline on Medical Device Real-world Study Design...

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