Streamlined Medical Device Registrations

As a manufacturer, you typically design and develop your product to launch in a specific market, for example, within the European Union, the United States, China, Brazil, Australia or any other global market.

Many medical device manufacturers decide, once the product is successfully on the initial market, to expand into other territories. Whilst CE marking and or FDA clearance or approval grant access to other countries beyond these regions, there are many countries that require additional local medical device registrations, such as Canada, Brazil, China, Japan, Mexico and so on. UDI requirements and registration in regulatory databases (e.g. such as EUDAMED) may be required in addition to obtaining device clearance and or approval.

While MDSAP certification supports Quality Management System compliance for many regions, it does not support the registration process of medical devices in these countries, which often requires additional submission of the technical documentation, with additional requirements that may apply. For example, in the European Union, there are specific quality management system requirements and technical documentation requirements which differ from those in the United States.

We do have experience in almost every single market, we can support many countries directly ourselves, or through our partners, liaisons and representatives we have globally. Reach out to us to find out how we can be of service to you. Whether it’s obtaining medical device compliance registration or navigating local medical device product registration, we’ve got you covered.