When you make design changes to an existing medical device, requirements in most major markets indicate you must notify the regulatory authority of your change. Unlike other markets, Japan PMDA registrants must submit even minor device changes.
As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database for Medical Devices, or Eudamed.
Im Bereich der Regulierung ma
Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU.
Medical Device Regulations in Peru