Global Registrations

Global Medical Device Registration: Navigating Worldwide Compliance

For manufacturers of medical devices and In Vitro Diagnostics, achieving compliance is a multifaceted journey. Beyond the fundamental steps of ensuring UK and EU compliance, there’s a broader perspective to consider when seeking to expand your product’s global footprint. At LFH Regulatory, we’re your guiding force, offering expert advice and actionable strategies to gain access to the global markets you aspire to reach. 

Expanding your product’s reach on a global scale necessitates a deep understanding of the unique regulatory approval processes in each target country. The journey towards international markets requires expertise in local and global regulations and a profound comprehension of the cultural dynamics influencing these processes. 

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​

European Union: In Vitro Diagnostic Regulation (EU 2017/746) and Medical Device Regulation (EU 2017/745)

Navigating the European market demands compliance with the In Vitro Diagnostic Regulation and the Medical Device Regulation, both of which entail comprehensive understanding and adherence.

United States​

United States: 510(k) Submission, Premarket Approval (PMA), De Novo Classification Request and Humanitarian Device Exemption (HDE).

The U.S. market requires an understanding of submission processes such as 510(k), PMA, De Novo Classification Request and HDE, all of which are essential for market access.

China

China: National Medical Product Administration (NMPA) Registration

Accessing the Chinese market entails registration with the National Medical Product Administration, a complex process requiring thorough comprehension.

Canada

Canada: Medical Device Establishment Licence (MDEL) and Medical Device Licence (MDL)

Compliance with Health Canada's requirements is crucial, involving both MDEL and MDL for market access.

Brazil

Brazil: ANVISA RDC 16/2013

ANVISA's regulatory compliance, particularly RDC 16/2013, is a vital component of accessing the Brazilian market.

Australia

Australia: Therapeutic Goods (Medical Devices) Regulations 2002

Australia's regulatory framework, the Therapeutic Goods (Medical Devices) Regulations 2002, is an essential consideration for market entry.

Japan

Japan: Pharmaceuticals and Medical Devices Act (PMDA)

Japan's complex regulatory landscape, governed by the PMDA, presents its own unique challenges.

Other markets

Beyond the key markets, there are diverse opportunities to explore markets in regions like Indonesia, Malaysia, India, the Middle East, and more. Our team is your strategic partner in gaining access to these markets.

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

Taking the Next Step: Your Path to Global Compliance 

Navigating the realms of global registrations is a wide-ranging endeavour, with regulatory processes varying by market. At LFH Regulatory, we offer comprehensive support, ensuring that you can bring your devices to your desired markets while remaining compliant at every step. 

Contact LFH Regulatory for Global Market Access 

Elevate your medical device’s reach to a global scale. Contact LFH Regulatory today to discuss your specific requirements and understand how to remain compliant with global regulations and standards.