Services
Renewal, variations and post-market
Keeping a registration valid: renewals, changes, vigilance and surveillance.
Renewal, variations and post-market
A registration certificate is valid for five years and has obligations attached for the whole of that period. We track expiry dates and start renewals in time, file variations when the manufacturer, manufacturing site, device name, configuration, labelling or intended use changes, report adverse events and coordinate field safety corrective actions and recalls with the authority, and maintain the post-market surveillance records that an inspection will ask to see.