Field of expertise
Market access based on the highest level
Qserve is a leading provider of global registration services for medical devices and in vitro diagnostics. With a team of experts and offices in Europe, US, Italy, and China, and local associates in South America, Asia, and the MEA region, Qserve is equipped to handle registrations in any part of the world. Our professionals stay up-to-date on the latest regulations and requirements to ensure that your device meets all necessary standards for market entry. From pre-market assessments to post-market surveillance, Qserve offers comprehensive support to help you navigate the global regulatory landscape and bring your device to market successfully. Whether you're looking to expand your reach into new territories or maintain compliance with existing regulations, Qserve is here to help.
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?
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CE Registration
To bring a medical device to the European market, companies must obtain CE Marking to show that their device meets the EU's safety and performance standards. Upon approval from a Notified Body (for Class IIa, IIb, or III devices) or Notification from the Competent Authority (for class I devices), the manufacturer can then display the CE mark on their product.
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FDA Registration
To sell medical devices in the US, companies must list their products with the FDA and register their establishments. This includes compliance with the Quality Systems Regulations and designation of a US Agent for companies without a US mailing address to act as their liaison with the FDA.
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NMPA Registration
Bringing your medical device to China can be a complex process, but with Qserve by your side, we'll help make it a successful journey. Navigating cultural differences and keeping up with constantly evolving regulations is no easy task, but with a local expert on your side, we can guide your device through the registration process, which can take anywhere from 1 to 3 years, depending on your product. Let us help you develop a strategy and handle communication with the Chinese authorities.
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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, Brazil, Colombia, Malaysia, India, Indonesia, Middle East and more.