Market Access based on the highest level
Our international team, local offices and professional alliances are your bridge to market access. We offer Market Access based on our global footprint combined with local regulatory knowledge and cultural understanding of the process. Choose for an independent license holder and stay in full control.
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 is 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?
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.
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.
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.
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.