Global Registrations

Global Registrations

As a manufacturer of medical devices or In Vitro Diagnostics, you need to be aware of the overall regulations within the markets you distribute. If you are looking to sell globally, you need to have consideration of the bigger picture with regards to what it takes to be compliant across the world. Ensuring you have checked your UK/EU compliance is the first step, but what happens when you want to promote your product further afield?

At LFH Regulatory, we advise you on what it will take to gain access to the global markets you require.

If you are looking to bring your product to the market on a larger scale, it’s vital to ensure you have an understanding of the local regulatory approval processes in those countries. Our team of experts is your bridge to access those markets. We offer support based on our global and local regulatory knowledge and cultural understanding of these processes.

European Union​

In Vitro Diagnostic Regulation ( EU 2017/746)

Medical Device Regulation (EU 2017/745)

United States​

510(k) Submission

Premarket Approval (PMA) Emergency Authorised Use (EUA)

China

National Medical Product Administration (NMPA) Registration

Canada

Medical Device Establishment License (MDEL)

Medical Device License (MDL)

Brazil

ANVISA RDC 16/2013​

Australia

Therapeutic Goods (Medical Devices) Regulations 2002

Japan

Pharmaceuticals and Medical Devices Act (PMDA)

Other markets

If you are looking to corner a different market in other areas like Indonesia, Malaysia, India, the Middle East and much more

How We Help

If you are looking for a specific market-access strategy based on global registrations, we provide support in a number of ways:

Identify Market Requirements

Identify and analyse specific in-country requirements against your current documentation, to effectively plan the route to your desired market.

Register Your Device

Prepare the necessary documents and register your device with the required regulatory body.

Next Steps

There is a lot to consider on the subject of global registrations and the regulatory process can differ depending on which market you wish to enter.  At LFH Regulatory, we provide a wide variety of support, ensuring you can get your device to your desired market while being compliant every step of the way. 

Contact us today to discuss your requirements and learn more about how we can bring your devices to market.