Regulatory Registered Agent and Legal Representative in Colombia
You must have a registered agent (aka legal representative or authorized agent) with a physical address in Colombia. We will provide our name and address in Colombia so that INVIMA can issue your registration certificate and send notices when needed. We will also facilitate that you comply with post-marketing technovigilance regulations.
Medical device manufacturers have the option to keep or control their registrations in many international markets. Companies prefer to appoint bioaccess.™ as their in-country authorized registered agent and regulatory legal representative in order to maintain control over their distribution channels, intellectual property, and post-market technovigilance regulations.
Foreign manufacturers must issue power of attorney to a local third-party in Colombia if they would like to have that third-party communicate with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), to submit an application to register a medical device, to receive INVIMA notices, and to represent their interest while doing business in Colombia.
The authorized agent or legal representative acts as a liaison between you, INVIMA, and any other private or government entity in Colombia. Foreign manufacturers that do not have a physical location within Colombia appoint and maintain that registered agent for as long as they market and sell their medical devices in Colombia.
Your registered agent in Colombia will manage your medical device registration process, will interact with INVIMA on your behalf, will receive legal notices on your behalf, and will ensure that you comply with local post-marketing surveillance requirements.
bioaccess.™: will act as your regulatory registered agent in Colombia fulfilling all regulatory responsibilities per national health regulations. You will assign power of attorney to us to file regulatory submissions to INVIMA on your behalf and to receive notices and appropriately respond to them.
We assume the liability of your company doing business in Colombia as, if there ever is a claim in Colombia relating to your medical device (even if the likelihood of such an occurrence is tiny), the party making the claim would enforce it against us. Due to the fact that this registered agent is based in Colombia, the claimant and the courts would have jurisdiction over it.
Before selecting bioaccess.™ as their registered agent, some manufacturers have considered appointing a distributor to fulfill this role. While it is possible to appoint a distributor located in Colombia, there are valid reasons not to appoint a distributor, including:
You may need to provide access to your medical device information and documentation (mandatory for registration purposes) and most companies prefer not to put (confidential) design information in the hands of their distributors.
A conflict of interest may occur in the event of a recall and/or incident reporting between you (the manufacturer) and the distributor. If INVIMA questions an incident or a non-compliance that occurred in the distribution system, will your distributor defend his company or yours?
3. The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your medical device.
4. The legal representative will assign an initial distributor and may need to assign additional distributors to the approval. If you select bioaccess.™ as your legal representative, we will fully cooperate with you so that you control the approval of your medical device on the market.
2,999 per year (for up to five products)
This offering includes,
We will be available to answer all your regulatory questions.
We will place our name, mailing address, email address, and phone number on your device submissions and registrations to INVIMA.
We will receive all INVIMA notices about your medical device, review them and share them with you to establish the best course of action.
Upon request by INVIMA, we will provide information about your medical device, and the names and addresses of distributors established in Colombia. We will have access to your medical device documentation for inspection by INVIMA if requested. Note that we can only supply this information for inspection by INVIMA upon written permission from you and cannot share it with any other person or entity.
We will be available to make changes (e.g., switching importer of record) to your existing registration certificate.
We will be available to coordinate inquiries, analysis and responses for reportable adverse events as reported by users, distributors, importers of record or INVIMA. We will help you determine the best response.
We will be available to provide technical assistance for the reporting of adverse events as reported by users, distributors, and importer of record.
We will be available to make certain your distributor or importer of record follows Colombia's post-market surveillance regulations.
We will be available to act as a liaison between INVIMA and you in case of recall or risk for medical device withdrawal from the market.
We will be available to help you submit to INVIMA the required annual report (if applicable to your medical device classification) stating:
Number of imported medical devices
Number of medical devices sold
Location of all medical devices sold
Serial number of all sold medical devices
Serious adverse events and the actions taken
Notes: This service is payable one-year in advance. bioaccess.™ will invoice 100% of the listed fee upon contract execution. The fee is for up to five (5) registration certificates. Excludes translations to Spanish or English and any applicable INVIMA fees. Assistance related to communications with authorities or other third parties in Colombia, where applicable, will be charged at the standard regulatory consulting hourly rate at the time of contract.