Before medical device manufacturers can legally sell their products in 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).
Interventional Concepts can assist with the preparation and submission of your device registration applications to INVIMA. We will compile your technical file, will review all labeling for compliance, and will provide post-submission assistance with INVIMA all the way through the approval of the device registration.
This offering includes,
Regulatory legal representation (3 years)
Unlimited regulatory and business strategy sessions with you.
Review of your market readiness (i.e., distributor partner program, contract, website, marketing material) and recommendations to successfully enter the market.
Search and selection of an INVIMA-certified importer of record (different from finding a commercial distributor).
Review of documentation and classification of your product.
When applicable, we will process the paperwork to transfer to your company's name any existing registration that a local distributor may have secured in Colombia for your medical device.
If needed in special cases, we will send INVIMA a formal petition letter to seek the agency's opinion on product classification or specific document requirements.
Preparation and submission of the final dossier package to INVIMA.
Answering post-submission follow-up questions from the INVIMA reviewer.
*50% payable upon receipt of invoice, and remaining 50% payable upon submission to INVIMA. It is assumed you already have approval for your device in the United States, Europe, Canada, Australia or Japan. Does not include cost of implementing or auditing a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable.
Medical Device Regulatory Registration in Colombia
Submission and registration
The following steps will be conducted in order to obtain the registration of your devices:
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 post-submission follow-up questions from the INVIMA reviewer
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 current 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 offering 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
- Documents which must be notarized/apostilled, such as your Certificate of Free Sale/Certificate to Foreign Government and Letter of Representation