Medical Device Registration in Colombia
Before manufacturers can legally sell products to, or within Colombia, they must be in compliance with Colombian device regulations and registration requirements. Medical Devices in Colombia are regulated by the National Institute for Medications and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA).
As part of this service, Interventional Concepts can assist with the preparation and submission of your device registration applications to INVIMA. Our services include compiling the technical file, reviewing all labeling for compliance, and post-submission assistance with INVIMA, through the approval of the device.
Device submission and registration
The following steps will be conducted in order to obtain the registration of your devices:
When applicable, we will process the paperwork to transfer to your company's name any existing registration that a local distributor may have in Colombia for your medical device.
Review of initial device information (intended use and claims) to verify the classification.
According to product classification, we will provide an applicable list of requirements for registration.
Preparation of the registration documentation after receiving the registration information from your company.
Assist and coordinate translations as needed.
Deliver the technical file to INVIMA.
Assist with any follow-up questions from the INVIMA reviewer post-submission.
Estimated time of completion
- Assembly: 30 days after receiving all the documents requested
Submission, follow up, and approval of registration by INVIMA: Class IIb and III device applications must first be reviewed and approved by INVIMA prior to being placed onto the market, which on average takes 4 to 6 months, depending on INVIMA’s review times. INVIMA automatically approves Class I and Class IIa devices.
Registration fees are due upon initial registration and are valid for 10 years. Renewal of the device registrations takes place after 10 years.
This service excludes:
- Translation fees:
- If certain documentation which requires certified translation, such as official certificates and the representation letter, are provided in English. In such cases, we will send the documents for certified translation in Colombia and will invoice you the amount at cost.
- If INVIMA does not accept the summarization of certain sections of the technical file, such as, but not limited to, the risk analysis report, biocompatibility or electrical safety test reports, and clinical data and requires that the full documents be provided in Spanish. Interventional Concepts can outsource this, if requested, to a local Colombian translator and will be invoiced to you at USD 0.25 per word in Spanish.
- User manuals or software Interface or Instructions for use.
- Legalization fees for documents which must be notarized/apostilled, such as your Certificate of Free Sale/Certificate to Foreign Government and Letter of Representation.
We require a deposit of 50% of the applicable registration service fee to start the registration process, with the balance due upon submission to INVIMA. Translation fees and official registration fees are not included and will be billed separately as they occur.