Medical Device Registration
Medical Device Registration for Global Markets
Health-authority registrations for medical devices, prepared from the technical file, the test evidence, and the local requirements of each market.
Medical Device Registration
Registration is how a tested device becomes a device a market will let you sell.
Health authorities register devices, not test reports. The filing names the device, its classification, its manufacturer, the evidence of safety and performance, and often a local party who holds the registration. A complete IEC 60601 report is necessary and not sufficient.
ORBIS prepares and follows the registration in each target market. We use the evidence from medical device testing and the technical documentation your team already has, and we say early when a market needs a local holder or a different classification.
How ORBIS scopes it
What decides the file
Classification first
The class of the device decides the evidence and the timeline. We confirm it before the file is built.
Local holding
Where a market requires a local registration holder, that is part of the plan, not a surprise at filing.
After the grant
Registrations expire, and changes to the device have to be reported. We keep that on the same file.
Questions
Before you start
We are already registered in one country. Can we reuse the file?
+
Much of the technical evidence can be reused. The form, the language, the holder, and often the classification cannot. We rebuild the filing, not the science.
Does this cover sanitary registration for cosmetics?
+
No. Devices are this service. Sanitary registration for cosmetics and related products is a separate path.
Bring the product and the markets.
We will tell you which of this work applies, which evidence you already have, and what still has to be done before the product ships.
Book a Discussion