FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

China Reports Progress at IMDRF Meeting

Nov. 28, 2018

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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