FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

China Reports Progress at IMDRF Meeting

Nov. 28, 2018
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Chinese regulators highlighted the country’s recent regulatory changes for medical devices at the recent International Medical Device Regulators Forum meeting in Beijing.

The changes include fast-track reviews for innovative devices, expedited procedures for accepting overseas clinical trial data and a simplified device renewal process.

To strengthen supervision, China’s Drug Administration established a professional inspectorate and added penalties for responsible persons that act as legal representatives for foreign device companies operating in the country.

To beef up compliance, CDA established a more centralized adverse event reporting mechanism. Under the new process, China’s Ministry of Health will re-evaluate whether certain devices represent new risks and what action should be taken.

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