Colombia Authorized Representative For Medical Devices
Local Regulatory Support for Market Entry in Colombia
Foreign companies entering Colombia may need a local importer, registration holder, notification holder or other authorized party. The role depends on the product and its regulatory pathway. “Authorized Representative” is not one universal legal role covering every product regulated by INVIMA.
For example, cosmetics use the Andean Notificación Sanitaria Obligatoria (NSO) system, while certain medical devices require the manufacturer to authorize a Colombian establishment to import or commercialize the product and, where applicable, hold its sanitary registration. Medicines have their own registration and holder requirements.
OMC Medical can help you identify the appropriate Colombian regulatory arrangement and coordinate the supporting work for your product category.
Colombia Authorized Representative: Key Information
Requirement | Details |
Regulatory authority | Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) |
Local role | Depends on the product: it may be an applicant, registration or notification holder, importer, or an authorized representative |
Medicines | The manufacturer, holder and importer roles should be confirmed for the specific registration pathway |
Cosmetics | Require an NSO before manufacture, import or commercialization; the NSO holder must be domiciled in a country of the Andean Community |
Medical devices | Manufacturer authorization to a Colombian establishment may be required to import, commercialize or hold the registration, as applicable |
Fees | INVIMA fees depend on the requested procedure; private representation fees are separate |
Validity | Depends on the product authorization and pathway; there is no single term for every representative appointment |
What Does “Authorized Representative” Mean in Colombia?
The phrase is often used commercially to describe a Colombian organization that supports a foreign manufacturer with regulatory submissions and local communications. The legal role in the filing may instead be described as the registration holder, notification holder, applicant or importer.
The manufacturer should establish in writing which local entity is authorized to import or commercialize the product and, where relevant, hold its sanitary registration. INVIMA’s medical-device requirements, for example, refer to a manufacturer-issued authorization for a Colombian establishment to import and commercialize the product and, where applicable, be the registration holder.
For medicines, INVIMA materials recognize that the manufacturer may be the registration holder or may authorize another party to hold the registration. The role should be confirmed for the product and filing rather than assumed to be the same as the medical-device representative role.
Local Regulatory Roles by Product Category
Product category | Local regulatory consideration |
Medicines | Confirm who will be the registration holder and importer, and what authority the manufacturer grants to the Colombian party. INVIMA’s procedures distinguish the holder, manufacturer and importer. |
Cosmetics | The product needs the applicable NSO. INVIMA states that the NSO holder must have legal domicile in an Andean Community member country. |
Medical devices and IVDs | For products under sanitary control, manufacturer authorization may identify the Colombian establishment that can import or commercialize the product and, where applicable, hold the registration. |
Food, supplements and other products | First confirm product classification and applicable authority. Requirements should not be inferred from the rules for medicines, cosmetics or devices. |
The NSO holder’s domicile requirement comes from Andean rules applied by INVIMA. For medical devices, the applicable pathway depends on the product and sanitary-control requirements. INVIMA announced in 2026 that a new decree brings specified device and IVD categories into the sanitary-control regime, so manufacturers should check whether their products are affected and review the implementation requirements.
What Can a Colombian Representative or Local Partner Do?
The scope should be agreed in writing and match the party’s actual regulatory role. Depending on the product and authorization, local support may include:
- Coordinating regulatory submissions: Prepare and submit applications or notifications through the relevant INVIMA process.
- Acting as applicant or holder: Hold or support the applicable product registration or notification when named in the filing.
- Supporting import and commercialization: Coordinate these activities where the local company is authorized and contracted to perform them.
- Managing regulatory communications: Receive and coordinate responses to INVIMA questions and requests.
- Maintaining product information: Coordinate updates to the manufacturer, importer, product or authorization details when required.
- Supporting post-market activities: Coordinate the handling and escalation of complaints, safety information and corrective actions as allocated in the agreement.
- Managing changes to the arrangement: Coordinate applicable regulatory steps if the holder, importer or representative changes.
These are possible service activities, not a single list of duties that applies to every product category. The manufacturer, local holder and importer should agree who is responsible for each activity.
Colombia Representation and Registration Process
1. Confirm product classification and pathway
Determine whether the product is a medicine, cosmetic, medical device, IVD, food supplement or another regulated product. Classification determines which application, notification or authorization route applies.
2. Identify the local applicant, holder and importer
Decide which entity will submit the application and whether it will also hold the authorization or import the product. One company may perform more than one role, but the filing and supporting documents should be consistent.
3. Prepare the manufacturer’s authorization
Where required, obtain a manufacturer-issued document that clearly identifies the Colombian company and the authority granted to it—for example, to import, commercialize or hold the product authorization. INVIMA’s medical-device documentation calls for manufacturer authorization to the importer and/or sanitary registration holder, as applicable.
4. Prepare category-specific documents
Use the current checklist for the applicable product and procedure. Do not reuse a cosmetics NSO checklist for a medicine or device application; their requirements and responsible parties differ.
5. Submit through the relevant INVIMA process
Submit the application or notification using the applicable INVIMA system and procedure. Track any requests for additional information and coordinate responses with the manufacturer and local parties.
6. Maintain the authorization and local arrangements
Keep the product information, authorization holder and importer details aligned with the commercial arrangement. Assess changes before implementation because a change in holder or importer may require an INVIMA filing.
How OMC Medical Can Support Your Colombia Market Entry
OMC Medical can help manufacturers assess local-role requirements and coordinate regulatory support for the relevant product category, including:
- Product classification and pathway review
- Local applicant, holder and importer role assessment
- Manufacturer authorization document coordination
- INVIMA application or notification support
- Regulatory correspondence coordination
- Post-authorization change and compliance planning
Need Local Regulatory Support in Colombia?
Start by confirming the product category and the responsibilities the Colombian entity will take on. OMC Medical can help map the appropriate next steps for your product.
Frequently Asked Questions
An Authorized Representative is commonly used to describe a local organization that supports a foreign medical device manufacturer with regulatory activities in Colombia. The exact legal role may be an importer, applicant or sanitary registration holder, depending on the applicable INVIMA requirements.
The requirement depends on the medical device category and its applicable regulatory pathway. Manufacturers should confirm whether a Colombian establishment must be authorized to import, commercialize or hold the sanitary registration for their product.
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is Colombia's regulatory authority for medicines, medical devices and other regulated products. It oversees the applicable sanitary authorization, registration and notification procedures.
Depending on the applicable procedure, documents may include a manufacturer-issued authorization identifying the Colombian establishment, product information, technical documentation and supporting documents required for the relevant INVIMA application. The exact checklist depends on the product and regulatory pathway.
A Colombian establishment may be authorized to hold the sanitary registration where the applicable requirements permit it. The manufacturer's authorization and the registration documents should clearly identify the responsible local entity.
The timeline depends on the device classification, applicable regulatory pathway, documentation completeness and INVIMA's review process. Manufacturers should confirm the current requirements and expected timeline for their specific product before planning market entry.
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