Frequently asked questions for clear regulatory decisions in Colombia.

Our end-to-end regulatory management focuses on medical devices, cosmetics, household and industrial cleaning products, personal hygiene products, and absorbents. In these sectors we support strategy, dossier preparation, legal holder, submissions, authority requests, changes, and renewals.

For pharmaceuticals and food we offer specialized training in health regulations, good practices, and compliance criteria. We do not operate as full regulatory administrators for those sectors.

Yes. Where applicable, we can act as the local holder for product registrations and NSOs in Colombia, especially for international companies that need a legally established representative in Colombia or within the Andean Community framework.

Yes. Software as a medical device is classified and registered with INVIMA under the criteria of Decree 4725. We evaluate the declared function, risk level, and available clinical evidence to define the classification strategy and dossier structure.

Yes, it is one of the most common scenarios we handle. We review the status of each authorization, identify upcoming expirations, pending changes, and continuity risks, and assume administration from wherever the portfolio currently stands.

We review product type, manufacturer, country of origin, composition or technical specifications, intended use, labels, available certificates, portfolio background, and commercial objective. With that, we define the compliance path with INVIMA.

It depends on the sector, product classification, documentation quality, and authority review times. We provide a case-by-case estimate including risks, dependencies, and possible authority requests.

Our team prepares the technical response, coordinates information with manufacturers or internal stakeholders, and, when useful, manages clarification spaces with evaluators. The priority is to defend the submission with solid evidence.

It depends on the sector and the regulatory path. For medical devices we typically require the technical datasheet, quality certificates, declaration of conformity, clinical evidence, and manufacturer documentation. For cosmetics: qualitative-quantitative formula, BPCos certificates, and labels. We conduct the documentary review as part of the initial assessment.

Registration is not a final milestone — it is the start of a lifecycle that requires ongoing management. We administer changes, renewals, quality alerts, tecnovigilancia or post-market surveillance obligations, and any event that may affect commercial continuity.

Vexpro operates as an integrated regulatory division. We do not respond only to isolated requests: we monitor validity periods, regulatory changes, modifications, renewals, and continuity risks so the portfolio remains marketable.

It means anticipating events that can stop sales: expirations, manufacturer changes, formula adjustments, labeling updates, authority requests, or quality gaps. Regulatory management is handled as a permanent business function.

Yes. We can integrate with internal teams as expert support, a technical second line, or regulatory function operators. The model adapts to each company's maturity and internal capacity.

We work under a monthly portfolio administration model. The structure includes an assigned team, direct access to the responsible regulatory specialist, and periodic status reports. Scope is defined based on number of products, sectors, and level of regulatory activity.

We actively monitor publications from INVIMA, the Ministry of Health, and Andean Community bodies. When a relevant regulatory update occurs, we assess the impact on each client's portfolio and prioritize the necessary adaptation actions.

A health registration (registro sanitario) is the authorization issued by INVIMA to market medical devices in Colombia. An NSO (Notificacion Sanitaria Obligatoria) is the mechanism for cosmetics under CAN regulations: the company assumes technical responsibility through a declaration, without INVIMA conducting a prior case-by-case evaluation.

Colombia classifies medical devices into four classes: Class I (low risk), Class IIA (moderate risk), Class IIB (high risk), and Class III (maximum risk). The classification determines documentary requirements, review timelines, and the level of evidence INVIMA requires.

Tecnovigilancia is the post-market surveillance system for medical devices. Manufacturers and importers are required by Decree 4725 and Resolution 4816 to report adverse incidents, international alerts, and withdrawal decisions to INVIMA. Non-compliance can result in sanctions and registration cancellation.

The holder is the legal or natural person that assumes legal and technical responsibility for the registration with INVIMA. For foreign companies without a Colombian subsidiary, Vexpro can act as the local holder and take responsibility for product compliance in the Colombian market.