A marketing authorization is not the end of your obligations. The SFDA runs the National Center for Medical Devices Reporting (NCMDR), a system for managing post-market surveillance activities such as receiving complaints and reports and following up on safety actions.
It is the ongoing monitoring of a device's performance and safety once it is on the market, handling incidents, malfunctions and complaints, and taking corrective action when needed.
Reporting serious incidents within the timelines set by SFDA requirements, notifying the SFDA of any corrective action by the manufacturer such as recalls or field safety notices, keeping distribution records to support traceability, and responding to SFDA queries on time.
Late reporting or weak distribution records can expose the registration and the establishment to regulatory action, and make it harder to recall a product quickly when needed.
As your Authorized Representative, we handle communication with the SFDA on reports and safety actions, and coordinate with the manufacturer and distributors until the case is closed.
Get in touch and we'll help with your specific case.
