Tag: regulatory changes

Illustration of a laptop computer showing Grace Fu Palma speaking during a presentation for a webinar

Grace Palma CEO is interviewed by RAPS on China Medical Device Amendment

June 27, 2018

On June 25, China State Council released a draft amendment to overhaul the medical device regulations. On June 27, Grace Palma, CEO of China Med Device,

The NMPA (CFDA) Announced Historical Medical Device Changes Today

June 26, 2018

The last time the NMPA (CFDA) “Medical Device Supervision and Management Regulations” were completely overhauled was in 2014 with a supplemental update in 2017. Today

CFDA Key Updates GMP/QMS Overview

December 18, 2017

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Tag: regulatory changes

Grace Palma CEO is interviewed by RAPS on China Medical Device Amendment

The NMPA (CFDA) Announced Historical Medical Device Changes Today

CFDA Key Updates GMP/QMS Overview

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NMPA Draft Clinical Guideline on Cardiac RF Ablation Devices – Implications for Boston Scientific, J&J, and Abbott

Clinical Evaluation of AI-Assisted Diagnostic Medical Devices — Draft Guideline Asks Feedback

NMPA’s Review Points for Tumor Gene Variation Detection Reagents: Key Highlights and Implications

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Key Takeaways and Best Practices of China Human Factor/Usability

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