Regulatory & market access
Regulatory pathways across our healthcare portfolio
Our healthcare portfolio addresses multiple market-specific regulatory pathways. The applicable mark, clearance or approval depends on the individual product and market.
iStatus varies by product, indication, software version and market. A mark shown for one product does not mean that every product holds the same status.
CEEU
A European conformity marking indicating that the relevant medical device has completed the applicable EU conformity-assessment route.
FDAUS
The U.S. FDA applies risk-based medical-device pathways that may include 510(k) clearance, De Novo classification or PMA approval.
UKCAGB
A Great Britain conformity marking used after a medical device has met the applicable UK requirements and assessment route.
NMPACN
China’s medical-device registration and filing framework, administered by the National Medical Products Administration.
MDAMY
Malaysia’s medical-device registration framework under the Medical Device Act 2012 (Act 737), administered by the Medical Device Authority under the Ministry of Health Malaysia.
PMDAJP
Under Japan’s PMD Act framework, PMDA conducts scientific product reviews and post-market safety activities, while the Ministry of Health, Labour and Welfare makes applicable approval decisions.