International Registration

CE Registration

In order to market medical devices in Europe, legal manufacturers must obtain CE Marking to demonstrate the medical device conforms with the “essential requirements” of safety and performance set out in the EU. Upon approval of the Notified Body (Class IIa, IIb or III medical devices) or Notification at the Competent Authority (Class I medical devices) the Manufacturer may place the CE mark upon its product. Read more

FDA Submission

All medical devices have to be listed with the FDA (Medical Device Listing) and all companies that will market medical devices in the US must first notify the FDA about their intention and register (Establishment Registration). Part of the process is the compliance with the Quality Systems Regulations (QSR) and all companies that do not have a US mailing address must designate a US Agent to serve as their intermediary with the US FDA. Read more

CFDA Registration

China is not an easy country to enter. You need patience and a local contact person who understands the culture and is able to keep up to date with the regulations, as they are changing constantly. Depending on your product, this registration process might take 1 to 3 years. A challenge, but together with you we set up a strategy and take care of the communication with the Chinese authorities. Contact us, we will guide your device through the registration process. Read more

Other Registrations

With offices in Europe, US, China and good local associates in South America, Asia and the MEA region, you can rely on us for registrations in many parts of the world: Europe, Australia, Canada, Russia, China, Japan, Brazil, Malaysia, Indonesia, Colombia, Middle East and more. Read more

Worldwide Medical Device Registration

In every country you have to show compliance again, local authorities will always have their own view.

A few questions that will come back at every registration:

  • Who will be the local license holder, will I need a local representative?
  • Will my test reports be accepted? What about my clinical evaluation?
  • How long will it take to register my medical device and what are the cost?
  • What will be the impact on my staff, do I have enough capacity?
  • What about local requirements like language, label and notifications in the European countries?

Are you looking for a specific registration or a strategy for multiple international registrations? 

Registration in Europe, the so called CE-Registration covers all countries of the European Union and a few more...Read more

FDA Submission can be arranged through on of our offices in the United States, learn more about the different options...Read more

Looking for a European Authorized Representative? Qserve's legal entity can act as legal representative...Read more

In need of a US Agent? Qserve's American offices assist with all FDA procedures...Read more

Our legal entities in China and Hong Kong can be used as local representatives...Read more

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