Importance of authorized representative services for medical device companies
In most countries, medical device regulators require foreign manufacturers with no local presence to appoint an in-country representative. Your in-country representative acts as your liaison to regulatory authorities and assists with managing your medical device registrations as well as market vigilance and adverse event reporting. It’s important to appoint a local authorized representative who is familiar with the medical device regulations and compliance requirements in your target markets in order to act in the best interest of your company.
More than 2,000 medical device and IVD companies worldwide maintain full control of their device registrations by appointing Emergo by UL as their local authorized representative.
Emergo's authorized medical device representative service areas
With offices around the world, Emergo by UL can act as your in-country representative in medical device and IVD markets across North and South America, Europe, Asia, the Middle East and Australia. There’s no need to deal with countless distributors and vendors for different services and territories. Our medical device representative services can help you expand your market reach and hit your business objectives through our local offices and partnerships in more than 15 markets.
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Choosing Emergo as your authorized medical device representative
In the rush to bring new medical devices and technologies to market, companies may not give enough thought to the appointment of their regulatory representatives and may appoint a distributor to fulfill this important role.
However, it’s important to note that in many medical device markets, your technical documentation, labeling, manuals and other information must include your in-country representative’s name and address. Some regulators even require you to name your representative on your registration certificate, giving them full control of your registration in those markets.
If you choose a distributor as your in-country representative and then decide to switch distributors, you will need to reprint your labels, manuals and other documents. Emergo’s authorized representative customers retain full control of their registration and are free to change distribution partners based on their business needs.
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