Market registrations

Ideally, a regulatory strategy should be planned as early as possible to make sure that the product is sufficiently designed, described and evaluated to meet regulatory requirements. A smooth registration is essential in any medical device market entry process as development is costly, and the time to market should be as short as possible.

In general, a medical device needs to be registered in the regulatory area/country before being able to start selling the device there. Each area has their own requirements and procedures. We have experience from registration of low and high-risk medical devices in the EU and in nearly 50 countries worldwide.

Access to the European Union (EU)

In the European Union (EU), the medical device manufacturer needs to show the device’s compliance with the General Safety and Performance Requirements (GSPRs) of MDR or IVDR. Based on the risk class of the device (I, Im, Ir, Is, IIa, IIb, III for MDR or A, B, C, D for IVDR), one of the applicable conformity assessment procedures must be chosen.

We assist non-EU medical device manufacturers that need a European Authorised Representative (EAR) to comply with European directives/regulations. We are a member of the European Association of Authorised Representatives (EAAR) and are part of a large international network within the industry.

US FDA registration

In the US, the FDA governs market access. If you are planning to sell MD or IVD devices in the US, owners and applicable operators will need to register and provide a list of devices. The documentation needed to demonstrate the safety and efficacy of the devices is based on risk classes I, II or III and the product code. FDA premarket approval, or clearance, refers to the process for non-exempt devices. The FDA will review the device and its documentation and there are several submission options available, while the most common are 510(k), De Novo or PMA.

Registration in the rest of the world

Medical devices need to be registered separately in each country outside of the EU since every country has its own medical device regulations. Having an EU CE mark and/or FDA clearance/approval will often make these registrations easier and more straightforward. Each country typically requires a local presence, i.e., an office or an agent. 

For example, to comply with UK regulations, medical device manufacturers must have a UK Responsible Person (UKRP) in the UK. Our UK-based company QAdvis UK Ltd. is one of the founding members of the UK Responsible Person Association (UKRPA), and we support non-UK medical device manufacturers with UK Responsible Person services.

We have expertise in registering devices in, for example, the following countries in addition to the EU and USA:

Argentina, Australia, Brazil, Canada, China, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Israel, Japan, Malaysia, Mexico, Nicaragua, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Sudan, Syria, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, Uzbekistan and Vietnam.