Medical Device Companies in Colombia: How to Register and Operate

A medical device company in Colombia is any company that manufactures, imports or distributes these products to market them in the country. To operate, it needs each device to hold the authorization INVIMA requires: a sanitary registration in most cases, or a marketing permit when it is controlled-technology biomedical equipment. That authorization is governed by Decreto 4725 de 2005 (Decree 4725 of 2005) and is the gateway to the market, whether the company manufactures the product or only markets it.

What does a company need to operate in medical devices in Colombia?

The central requirement is the product’s health authorization. No medical device can be marketed in Colombia without a sanitary registration from INVIMA, and that registration must be obtained before putting the product on the market. How demanding the procedure is depends on the device’s risk class: a class I is approved with general controls, while a class III goes through a much more rigorous regime. The registration is valid for 10 years for all classes and is processed through the Oficina Virtual, INVIMA’s online portal (app.invima.gov.co).

Before reaching that procedure, the company needs to have two things settled: which risk class its device falls into and who will be the holder of the registration. Both decisions shape the rest of the process.

Manufacturer, importer and distributor: what changes by role

The category of medical device company covers different activities, and it helps to separate them because each carries different weight in the procedure. The starting point is the same for all: the device must be covered by its health authorization before it circulates in the market.

Manufacturer

The manufacturer produces the device. It can be in Colombia or abroad. When it manufactures inside the country, it usually takes on the registration of the product it makes directly. When it manufactures abroad, it reaches the market through a company established in Colombia that handles the importation and the procedure with INVIMA.

Importer

The importer brings devices manufactured abroad into the country. In practice, it is the figure through which a foreign manufacturer enters the Colombian market, because the procedure with INVIMA is taken on by a company with a local presence. An imported device needs its sanitary registration just like one manufactured in Colombia.

Distributor

The distributor markets devices that already hold a health authorization. It buys from manufacturers or importers and gets the products to clinics, hospitals, pharmacies or the end user. Beyond each product having a current sanitary registration, the distributor must hold the permit from the health secretariat to store and distribute medical devices. Marketing a device without authorization exposes the whole chain.

Who can be the holder of the sanitary registration?

The holder is the person, natural or legal, who applies for the authorization with INVIMA and answers for the device before the health authority. It can be a domestic or foreign company. It is the one that appears on the registration and takes on the obligations that come with it: keeping the product’s information current and renewing the authorization before it expires. Deciding who will be the holder is an early decision, because the importation, the marketing and the regulatory responsibility for the product in the market all depend on it.

The role of the importer or representative in Colombia

When the manufacturer is outside Colombia, it reaches the market through a domestic company that takes on the importation and the procedure with INVIMA. That importer must hold the Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA), or Storage and Conditioning Capacity Certificate, granted by INVIMA, current and valid. The holder of the registration and the importer can be the same company or different companies: the holder can be domestic or foreign, while the importer must always be a domestic company with a CCAA. For a foreign manufacturer, that local ally is a weighty decision, because it takes charge of the importation before INVIMA and of the relationship with the health authority while the product is on the market.

General steps to enter the market

Each device has its own path depending on its risk class, but the route for a company that wants to operate in Colombia follows a general sequence:

1. Classify the device in its risk class (I, IIA, IIB or III). Everything else depends on that.
2. Decide who will be the holder of the registration and, if the manufacturer is abroad, which local company will take on the importation.
3. Gather the product’s legal and technical documentation. The requirements depend on the type of device and its class, so they are checked case by case at invima.gov.co.
4. File the application with INVIMA through the Oficina Virtual (app.invima.gov.co) and obtain the sanitary registration, or the marketing permit if it is controlled-technology biomedical equipment.
5. Keep the registration current and renew it at least 3 months before expiration, since the validity is 10 years for all classes.

The detail of the procedure, the documents and the timelines is in our complete guide to INVIMA sanitary registration. And to place the risk class correctly, which is the first step and the one that trips companies up most, you can rely on the guide to medical device risk classification.

Common mistakes companies make

The slip-ups repeat regardless of the size of the company. The costliest is classifying the device below its real risk, something that can end in the rejection of the application. Another common one is assuming that a similar product already on the market defines the class, when each case is analyzed separately. It also matters to confuse controlled-technology biomedical equipment, which goes through a marketing permit, with an ordinary medical device, which goes through a sanitary registration. And there is the classic of letting the registration lapse by not scheduling the renewal, which can halt marketing until the authorization is restored. Each of these mistakes can cost months.

How SPI Américas supports medical device companies

Registering and operating medical devices in Colombia starts with two well-made decisions: the product’s risk class and who will be the holder of the registration. Based on the experience of SPI Américas’ regulatory team, these are the points where companies get most stuck when entering the market. The regulatory affairs team at SPI Américas supports manufacturers, importers and distributors in classifying the device, defining the holder, preparing the sanitary registration or the marketing permit as applicable, and renewing current authorizations. If your company is going to manufacture, import or distribute medical devices in Colombia, write to us at [email protected].

Official sources cited

Decreto 4725 de 2005 (classification and registration of medical devices), invima.gov.co, normograma.invima.gov.co.