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Colombia Regulatory Representation for Medical Device Companies

Interested in registering and marketing your medical device in Colombia? If you have no local presence in the country, you are required to appoint a Colombia Legal Representative as part of your regulatory approval process.

Appointing a Legal Representative in Colombia

What makes Colombia different from other countries that require in-country representation is that the Legal Representative in Colombia must be a properly licensed lawyer. In addition, foreign medical device manufacturers must provide their legal representative in Colombia with power of attorney. Once this relationship is established, your Colombia Legal Representative manages your registration process and interacts with the country’s medical device regulator, INVIMA, on your behalf. You must maintain your Legal Representation relationship for as long as you market your device in Colombia.

We maintain a local office in Bogota

Emergo has an office in Bogota, and has the resources and expertise to serve as your Colombia Legal Representative in order to bring your medical device to market in Colombia. Acting as your independent Legal Representative, we can focus fully on Colombian regulatory affairs and how they affect your medical device registration, as well as assign Colombian distributors based on your sales and marketing requirements.

Please contact us for more information on our Colombia Legal Representative service.

Ask us for detailed information about Colombia legal representative services.

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Commonly Asked Questions

How do I control my approval with Emergo Group as my Legal Representative?
When companies register through a local distributor, instead of an independent lawyer/legal representative, the distributor will often list themselves as an owner on the registration, along with the foreign manufacturer. In this case, this means that any future modifications, such as adding a new distributor, models, etc., would need to be approved by both the manufacturer and the distributor. As your Legal Representative, Emergo Group will register your devices in only your name, ensuring that no other companies are listed that would limit your control over your approval.
Can I transfer my registration to another local registration holder?
Registrations can be transferred in Colombia as long as the original owner(s) will agree. If the owner includes a distributor, they usually are not willing to give up control of an application, and often companies need to submit a new application. If you select Emergo Group as your legal representative, then you can move or change your registration as needed, since we will submit the applications with you as the owner and controller of the registrations.