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Independent Regulatory Representation for Medical Device Companies

In the rush to introduce a new product, many companies give little thought to the appointment of their in-country regulatory representative and appoint a distributor to fulfill this important role.

Business person sitting at a conference table with two medical professionals

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 vendors for different services and territories. We can help you expand your market reach through 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)
European Authorized Representative for Clinical Trials
Hong Kong Local Responsible Person
Israel Registration Holder
Malaysia Authorized Representative
Mexico COFEPRIS Registration Holder
New Zealand Sponsor
Peru Registration Holder
Saudi Arabia Authorized Representative
Singapore Authorized Representative
South Korea License Holder 
Switzerland Authorized Representative
Taiwan Agent
United States FDA US Agent
United Kingdom (UK) Responsible Person

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 flexibility and control of your registrations

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.


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