Registration of medical devices, pharmaceutical drugs, dietary supplements, cosmetics and personal hygiene products in Colombia
Before foreign manufacturers can legally sell their regulated products in Colombia, they must be in compliance with Colombian health regulations and registration requirements. Food, medical device, drugs, dietary supplements and cosmetic products in Colombia are regulated by the National Institute for Medications and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA).
We can assist with the preparation and submission of your product registration dossier file and application to INVIMA. We will compile your technical and legal 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,
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, gap analysis 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 product.
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 file 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. If your product already has marketing authorization in the US, EU, Canada, Australia or Japan, INVIMA will approve your product faster. For medical devices, pricing 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.
INVIMA Regulatory Registration in Colombia
Submission and registration
The following steps will be conducted in order to obtain the registration of your medical product:
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 you.
Assist and coordinate translations as needed.
Deliver the technical file to INVIMA.
Assist with any post-submission follow-up questions from the INVIMA reviewer.
- Assembly of dossier file: Approx. 30-45 days after receipt of documents.
Submission, follow up, and approval of registration by INVIMA (approx. times).
Medical devices: 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 3-6 months (approx.), depending on INVIMA’s current review times. INVIMA automatically approves Class I and Class IIa devices.
Drugs: 90 days
Dietary supplements: 90 days
Food: 90 days
Personal hygiene: Automatic
- Medical devices: 10 years
- Drugs: 5 years
- Dietary supplements: 10 years
- Food: 10 years (low risk), 7 years (medium risk), 3 years (high risk)
- Cosmetics: 7 years
- Personal hygiene: 5 years
*Source: INVIMA (in Spanish).
This offering excludes:
INVIMA fees (USD): Medical devices: 1,000. Drugs: 1,200 to 14,000 depending on the type of drug and whether your product has FDA or EMA marketing authorization or not. Food: 2,000. Cosmetics: 800. Personal hygiene: 500. Nutritional supplements: 1,500. These fees are valid until december 2018 and are approximated due to exchange rate fluctuations.
- Document translations to Spanish. LATAM Market Access Inc. can translate these documents and will invoiced you at USD 0.25 per word in Spanish.
- Documents which must be notarized/apostilled, such as your certificate of free sale/certificate to foreign government and letter of representation.
- INVIMA visit to a foreign manufacturing plant (if applicable).
- Biological/biotechnology/biopharmaceutical drugs.