With over 50 million inhabitants, Colombia is after Brazil and Mexico the third most populous country in Latin-America (LATAM). Ranking number 4 in GDP after Brazil, Mexico and Argentina. An associate member of Mercosul group of countries in the region. From an operational standpoint, it would be worthwhile adding that manufacturers have established Latin American offices in the country given the proximity to Central America and the South American countries. While also Colombia does benefit from having Free Trade Zones, which allows distributors from other countries in the region to collect deliveries and stock from warehouses within the Free Trade Zone regions.
Overall healthcare infrastructure is being modernized (with still a considerable difference between urban and rural areas) and the country offers ample opportunities for foreign medical device and diagnostics manufacturers to start exporting to Colombia. The market is mature and highly competitive, with many foreign firms selling medical equipment and medical products. Like many other countries, Colombia is seeing an increase in non-communicable diseases, particularly cardiovascular disease, cancer, and diabetes, that will have an impact on the development of Colombia's healthcare market over the coming years.
Interesting to note is that the Colombian Health care system is ranked relatively high on a worldwide scale. The Legatum Institute, a London based think tank evaluated Colombia as the 36th ranked Healthcare system in the world. This ranks favorably against the US (ranked 69th), comparable to the UK (ranked 34th) and only just behind Uruguay (ranked 35th) as the leading countries in South America. Large countries like Brazil (83rd) and Mexico (71st) were ranked below (https://en.wikipedia.org/wiki/Legatum_Prosperity_Index).
Health insurance
All citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefits package. This universal medical coverage for all citizens is known as the “General System of Social Security in Health” (SGSSS, or Sistema General de Seguridad Social en Salud). A new bill from 2023 aims to improve primary care, expand access to treatment and raise healthcare worker salaries. This reform could set up primary care centres to guarantee swift patient care, with increasing opportunities in the medical devices market. It’s good to know that the Colombian health system comprises two coexisting systems: the contributory regime (private) and the subsidized regime (gratuitous). Private employees and employers finance the private health regime out of their paychecks while the Colombian state entirely funds the subsidized regime. Both coexisting systems provide universal coverage with equal access to medicines, surgical procedures, and medical/dental services.
Medical devices market
Its medical device market is highly competitive and close to 90% of devices needed are being imported. As in many other LATAM countries, domestic production focuses primarily on low-tech products and consumables (e.g. syringes, catheters and prosthetics). Free trade agreements with the US, Canada and the EU make importation from these markets relatively easy. More than 50% of total imported devices comes from the US, China and Germany.
Best prospects for foreign medical devices manufacturers are in following categories:
Laboratory consumables and equipment
Diagnostic imaging equipment
Electro-diagnostic apparatus
Medical, surgical, and dental instruments
Orthopaedics & prosthetics
The medical device market represented 5.3 percent of health expenditure in Colombia in 2022. The Columbia government is the primary buyer and public tender opportunities play a key role in this. The Government of Colombia is the primary buyer, and U.S. companies can find public tender opportunities on the Ministry of Health (MoH) website and on the Colombia Compra Eficiente website (Colombia Compra Eficiente is the government’s Public Procurement System, and it offers participants tools to facilitate the tender process in the Colombian Public Procurement System).
The best approach to enter the market is through a local partner, such as a Colombia medical device distributor or a distributor that is more specialized in the distribution of diagnostics products. Colombian companies prefer to buy from companies with a local presence that can provide in-country after-sale services; however, some of the country’s largest end-users import equipment and supplies directly.
Colombia medical device and IVD regulatory process
Both medical Devices and IVDs are subject to the local registration procedure and need to be registered with INVIMA to be marketed in Colombia (being one of the less complex registration processes in LATAM). The National Drug and Food Regulatory Agency (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or Invima) residing under the Ministry of Health and Social Protection, is in charge of “inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards and procedures, implementing best practices, and providing medical approval for the import and export of products”. This to assure the safety, efficacy and quality of medical devices being offered on the market.
Any foreign manufacturer that doesn’t have a legal presence in Colombia and that wishes to export products to Colombia requires an IOR (Importer of Record). The IOR assures that imported products meet the laws and regulations of Colombia. In order to receive a market clearance certificate, the IOR is required. The IOR is among others responsible for proper documentation of imported products, duties, tariffs and that fees are paid. The IOR needs to have a CCAA (The Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA) ensures that the necessary safety and health requirements are met for imported products into Colombia).
There are basically two options for product registration in Colombia. The manufacturer could elect to have themselves as owner of the product register (and appoint a Colombia legal representative or authorized representative as an in-country liaison with INVIMA). The distributor would become an importer on the product registration (with own warehouse for storage). They would not need to hire a CCAA as the CCAA links with the importer. Therefore the distributors CCAA would be included in the product register.
Alternatively, the manufacturer can elect for a national distributor who would complete the product register themselves (and act as authorized representative). The owner of the register would be the distributor as well as importer with their CCAA. The manufacturer stays legal manufacturer of course and should they require to change the distributor in the future, they would either need to complete a transfer from one distributor to another or create a new register. Note that if the distributor is the owner of the register in Colombia, the manufacturer cannot add distributors or change distributors themselves due to the fact that they are not the owner of the register but are only cited as the manufacturer on the register. And the distributor is the owner.
The main reason to own the CCAA as manufacturer is following: should in the future you need to change the distributor, this is a simple amendment on the register as owner to remove a distributor and add a different distributor (or even add more than one distributor for that matter). If the distributor owns the register, a transfer would need to be completed between distributors and this would need the consent of the owner which would be the distributor. If the split is not amicable and the distributor refuses to transfer the register, a new or second product register would need to be completed.
But should the relationship end between the distributor and the manufacturer, this does not mean that the register cannot be transferred. With the authorization/acceptance of the distributor/owner of the product register, the register can be transferred to the manufacturer or other distributor of the manufacturer’s nomination. Normally the distributor will want costs covered for the transfer and possibly some reimbursement of costs such as translations when first making the register. But the transfer can be made.
Should the relationship not end amicably, and the distributor/owner does not authorize the transfer, it is possible in Colombia that the same product can have more than one register. Therefore it would be possible for the manufacturer or new distributor to enter and complete a 2nd product register.
Medical device product classification
The device classification system in Colombia is quite similar to that of the EU and other Global Harmonization Task Force (GHTF) systems. The classification follows a four-tiered risk model (Class I, Class IIa, Class IIb, and Class III). If the device falls into a lower-risk category in Colombia (Class I or IIa), the company may qualify for an expedited review and achieve market entry in a shorter time.
Medical device and IVD product registration process steps
After correct classification of your product, following steps must be completed before being able to sell your medical device or diagnostics product in Colombia:
An in-country representative (or legal representative), needs to be appointed in case you have no local presence in Colombia. This can be a distributor or a third party;
Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from either your home country or from a market that is recognized by INVIMA as such (US, EU, Australia, Canada or Japan);
Provide a quality system certificate (QMS). Example is an ISO 13485 certificate, an FDA establishment report or MDSAP;
Provide product information (like the technical file, labeling and IFU) and the commercial history of the product. For Class IIa, IIb and III devices test reports are mandatory. For Class IIb and Class III devices clinical data is needed;
All required documentation needs to be submitted to INVIMA (please note that this has to be in the Spanish language) while paying the required application fee;
Once the documents have been approved and requirements are met, INVIMA will issue a registration certificate.
It might be that INVIMA wishes to carry out an inspection of the manufacturing site assuring compliance to so called Good Manufacturing Processes (GMP).
The Colombia medical device registration process time is dependent on the product classification. Class I and Class IIa submissions are immediately accepted (which means products can be imported right away after submission) while Class IIb and III could take up to 8 months before it’s possible to sell them on the Colombian market. Registrations have a validity of 10 years. Government (INVIMA) fees for registration are around $1,000.-
Product labelling has to show essential information like the intended use, important precautions and the manufacturer’s contact information and has to be in Spanish. Documents provided for registration have to be in Spanish as well.
Post market surveillance is required to ensure the quality and safety of medica devices. Post marketing activities need to be carried out in specific cases like adverse events reporting, submission of variation applications (modifications to products) and registration renewals.
Luctor Medical can provide the required Colombia medical device and IVD regulatory services. Please contact us in case you have an enquiry.
Colombia medical device and IVD distributor
Meditech (https://feriameditech.com/) is the most important exhibition for the health sector in Colombia. Key stakeholders from the medical industry will attend and it’s the best opportunity to meet existing and new business contacts and present your product with the support of your local partner.
For local distributors it is important that they have the right connections in the market and a good national distribution coverage. This often means that they have offices and staff in or near the major cities (like Bogotá, Medellin and Cali). Luctor Medical has the local expertise to support you in finding the right, qualified Columbia medical device and IVD distributor to successfully represent you in the market.