INVIMA Health Registration in Colombia: Complete Guide for Exporters

INVIMA health registration (registro sanitario) is the administrative act that authorizes a person or company to manufacture, import, export, package, process, or sell food, drugs, medical devices, and cosmetics in Colombia. Without this registration, selling these products in the Colombian market is illegal. Penalties for non-compliance include fines of up to 10,000 monthly minimum wages (approximately $3.2 million USD in 2026), product seizure, and temporary or permanent closure of the business. If you're a US or international company looking to sell regulated products in Colombia, INVIMA registration is a mandatory first step.

Which Products Require INVIMA Registration?

Not all products require the same level of regulatory approval. Colombia's system has three tiers:

• Registro Sanitario (Health Registration) — Required for drugs, biological products, dietary supplements, high-risk food, and Class IIb/III medical devices. Most rigorous, longest timeline.
• Permiso Sanitario (Health Permit) — For medium-risk food products (dairy derivatives, processed meats, alcoholic beverages). Faster than full registration.
• Notificación Sanitaria (Health Notification) — For cosmetics, cleaning products, low-risk food, and Class I/IIa medical devices. Simplest and fastest process.

Step-by-Step Registration Process

Step 1: Identify Your Registration Type

Determine whether your product requires a registro sanitario, permiso sanitario, or notificación sanitaria based on its risk category. Check INVIMA's website (invima.gov.co) or consult a local regulatory specialist. The registration type depends on the product, not on the fact that it's imported — an imported drug requires the same health registration as a locally manufactured one.

Step 2: Prepare Documentation

• Application form completed on the INVIMA platform (tramites.invima.gov.co).
• Certificate of Incorporation and Legal Representation (Chamber of Commerce, less than 90 days old).
• GMP (Good Manufacturing Practices) certificate from the manufacturing facility — if foreign, must be apostilled or legalized.
• Qualitative-quantitative formula (detailed composition with percentages).
• Finished product quality specifications (physical, chemical, microbiological analyses as applicable).
• Stability studies (shelf life data).
• Proposed labeling compliant with Colombian regulations.
• Certificate of Free Sale (CFS) from the country of origin — apostilled and officially translated to Spanish.
• Power of attorney for the INVIMA legal representative, if applicable.

Step 3: Submit and Pay

All applications are filed through INVIMA's online platform. Create an account, select the procedure type, upload digitized documents, and pay the corresponding fee. The system generates a tracking number for follow-up.

Step 4: INVIMA Evaluation

INVIMA reviewers evaluate the documentation and may: approve directly, request additional information (you have 30 business days to respond), or deny the application (with 10 business days to file an appeal). Evaluation timelines vary significantly by product type.

Costs and Timelines

• New drugs — $5,000-$11,000 USD in INVIMA fees. Timeline: 6-12 months (can extend to 18 months).
• Class III medical devices — $2,000-$3,700 USD. Timeline: 3-6 months.
• High-risk food — $1,100-$2,000 USD. Timeline: 2-4 months.
• Medium-risk food (permit) — $600-$1,100 USD. Timeline: 30 business days.
• Cosmetics (notification) — $375-$750 USD. Timeline: 3-5 business days.
• Renewal — Generally 60-80% of the initial application cost.
• Budget an additional $3,000-$10,000 USD for a local regulatory consultant, official translations, apostilles, and lab testing.

Validity and Renewal

Health registrations for drugs and food are valid for 10 years. Cosmetics and cleaning products under notification have no expiration. Renewal applications must be filed at least 3 months before expiration. If the registration lapses, you must start the entire process from scratch.

Tips for US Companies Entering Colombia

• Hire a local regulatory consultant — The cost ($3,000-$10,000 USD) pays for itself by avoiding months of delays from documentation errors.
• Start the GMP inspection early — If INVIMA needs to inspect your US manufacturing facility, scheduling and completing the visit can take 6+ months.
• Prepare Spanish translations proactively — All documents must be in Spanish. Use a certified translator and plan for 2-4 weeks per document set.
• Apostille everything — Documents from the US need an apostille from the US Secretary of State (or state-level equivalent). Plan 2-6 weeks.
• Align labeling with Colombian standards — Colombian labeling requirements differ from FDA rules. Nutritional panels, allergen warnings, and health claims must comply with local regulations.
• Use the same HS code — Your tariff classification for DIAN customs should be consistent with your INVIMA product category to avoid cross-referencing issues.

How Camtom Helps Exporters to Colombia

INVIMA registration is just one piece of the Colombia import puzzle. You also need correct tariff classification under the Colombian tariff schedule, import declarations filed with DIAN, and VUCE compliance. Camtom handles the tariff and documentation side: AI-powered classification, duty and VAT estimates, and document management. While your regulatory consultant handles INVIMA, Camtom ensures the customs side doesn't become another bottleneck. Try Camtom free at camtomx.com/registro.