Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. It’s important to choose a representative who is familiar with the regulatory requirements for your product to act in the best interest of your company.
More than 2,000 companies worldwide maintain full control over their device registrations by appointing Emergo as their independent, professional representative – here’s why:
Global representation through one point of contact
With offices around the world, Emergo can serve as your in-country representative in major medical device markets like the US and Europe and emerging markets like Colombia and Malaysia. There’s no need to deal with countless distributors or vendors for different services and territories. We can help you expand your market reach through our local offices and partnerships in over 15 countries. Explore our representation services:
Australia TGA Sponsor
Brazil ANVISA Registration Holder
Colombia Legal Representative
Costa Rica Registration Holder
Europe Authorized Representative (EC REP)
Hong Kong Local Responsible Person
Malaysia Authorized Representative
Mexico COFEPRIS Registration Holder
New Zealand Sponsor
Peru Registration Holder
Russia Authorized Representative
Saudi Arabia Authorized Representative
Singapore Authorized Representative
South Korea License Holder
United States FDA US Agent
If you are based in the UK or selling devices in the UK, we can help you prepare for a smooth Brexit transition. Contact us to learn more.
100% focused on regulatory affairs for medical devices and IVDs
Medical device regulatory compliance is our business. As your regulatory representative, you can rely on us to keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices. We will act in the best interest of your company in response to a recall or adverse event based on our years of experience navigating sensitive compliance issues.
Independent representation gives you control of your registrations and post market surveillance
In many markets, your technical documentation, labeling, manuals, and other information must include your in-country representative's name and address. In others, your representative is named on your registration certificate, giving them full control of your device registration in that market.
If you elect a distributor as your representative then decide to switch distributors, you will need to reprint labels, manuals, and more. Our representation clients have full control of their registrations and are free to change distributors based on their commercial needs. Selecting Emergo as your in-country representative in multiple markets gives you centralized control of your global post-market surveillance responsibilities, including coordinated adverse event reporting.