The Regulatory Education Framework of US Medical
Device Regulatory Authorities and Implications for China

doi:magtech.2025.08.05-00001

Abstract

Abstract:

Objective： The educational and training activities for regulated entities （hereinafter referred to as "regulatory education"）， such as in-person training and online courses， enable industry practitioners to acquire in-depth regulatory knowledge and strengthen their compliance awareness. This contributes to advancing the high-quality development and high-level safety of the medical device industry， serving as a critical initiative in China’s efforts to deepen medical device regulatory reform. This study examines the regulatory education framework implemented by US medical device regulatory authority for practitioners， aiming to provide references and insights for optimizing the form and content of regulatory education by Chinese medical device regulatory authorities.Methods： Case analysis approach was adopted， utilizing publicly available information to study regulatory education resources provided by US medical device regulatory agencies to practitioners， such as training courses， training conferences， and text-based guidance information.Results and Conclusion： Center for Devices and Radiological Health （CDRH） of US Food and Drug Administration （FDA） has implemented educational activities towards different audiences based on the regulatory process and regulatory requirements. Through diversified forms such as static text information， multimedia courses， online seminars， offline interactive meetings， CDRH has provided practitioners with multi-level educational resources covering process introduction， quick review of regulations， systematic training， and in-depth communication. These resources are integrated into a quick and accessible resource list in the form of Educational Newsletter. China's medical device regulatory authorities can draw on such practices， starting from top-level design， to improve the regulatory education system， optimize the allocation of educational resources， and provide high-quality regulatory educational resources that are timely， practical， and interactive to the medical device industry.

Key words: Food and Drug Administration , （FDA）； , Center for Devices and Radiological Health , （CDRH）； , Regulatory education； , Medical devices； , Industrial training

CLC Number:

ZHOU Shijie, PANG Bo, GENG Yinglun, LI Yaohua.

The Regulatory Education Framework of US Medical Device Regulatory Authorities and Implications for China [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2025, 27(12): 1250-1250-1256.

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The Regulatory Education Framework of US Medical Device Regulatory Authorities and Implications for China

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