Medical Plastic Data Service Magazine

 
 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 32nd Year of Publication
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Global Market - Medical Devices

Colombia Medical Devices Market

Mr. Amit Dave
M. Pharm, MBA,
Former CEO - Brazil Operations/ Vice President Export – Zydus Cadila/Claris Lifesciences

Country Profile

Colombia saw armed conflicts and political violence in the 1960s, and in the next three decades, such instability increased. Since the beginning years of the 20th century, the situation has improved significantly. Law and order situation was established with stability and better security after this. This followed dramatic economic growth also. Colombia is one of the most stable economies in Latin America. A strong financial institutional setup, a fairly disciplined fiscal framework, a relatively flexible foreign exchange rate, and a clear eye on inflation monitoring have been the strong pillars of this country. Gaps in infrastructure and education curriculum systems still need attention as per the World Bank. The capital city is Bogota. It needs to be noted that Colombia has social and territorial inequalities. Post-pandemic recovery of the economy is also not as desired (where India has done fairly well in this regard).

Colombia has the highest level of biodiversity per square mile in the whole world, with diversity covering Amazon rainforests, highlands, deserts and grasslands. With a 52.7 mn population, Colombia is the third most populous country in LATAM, after Mexico and Brazil. With a per capita GDP of 19,770 USD, and a well-established healthcare system, the country offers a decent opportunity in the healthcare sector. Now Colombia is considered to have a very decent healthcare system with the best standards in the whole of Latin America, an important point from a market perspective.

Colombia Highlights

• A fairly large and stable market
• A decent and growing economy
• More than 80% of devices requirements are imported
• Regulatory mechanism very clear and clean
• Very competitive pricing dynamics

 

Like many other countries of LATAM (and unlike Brazil), here also, the official and prevailing language is Spanish.

 

Regulatory Framework Outline and Product Classification

 

INVIMA (The National Institute for Food and Drug Surveillance) is the regulatory agency for Colombia (https://www.invima.gov.co). (The webpage is in Spanish. However, after clicking English/Translation, English matter appears.). Like in all the LATAM markets, here also, the role of a local representative partner becomes important. In general, the local partners in the surgical field are good and well-conversed with the local authorities. Unlike some other LATAM countries, the corruption level is almost nil, and the agency works with diligence. Pre-registration consultation directly with INVIMA through their website is also possible for some issues if needed.

 

Classification of medical devices –

 

• Class I (low risk)
• Class IIa (moderate risk)
• Class IIb (implantable devices)
• Class Ill (high risk)

 

This is fairly aligned with the international guidelines or IMDRF framework.

 

Approval for medical devices in general takes about 6 months if the set of documents is correct. The partner’s Regulatory person generally scrutinizes these documents and thereby, the process may become faster (4 months). Post-approval amendments are easy and may take only 2 months.

 

A few important points in this regard are - 1. There needs to be a legal representative for registration in this country (a distributor or a regulatory consultant agency). 2. Labelling requirements (label in Spanish) are also crucial for Colombia for devices. 3. For Class III (high-risk) devices, the authorities may need clinical trial data also. 4. The most important point is product approval in the USA or EU approval. This will facilitate the approval here. Testing by foreign INVIMA-listed labs is acceptable.

 

In LATAM, Colombia approvals are considered the fastest and most predictable.

 

Colombia Medical Devices Market

 

Colombia is the third largest medical devices market in the LATAM region, in line with the population rank. The market size estimates are about 1.5 bn USD with a growth rate of 5.7% pa. Rising emphasis on health by the Government is the main factor which may drive this growth. However, some experts predict that the growth rate may go down to 2.5% due to economic factors. In Colombia also, both public and private healthcare sub-sectors prevail. Health is a fundamental right provided in the constitution, and so, while the public healthcare system is entirely funded by the government (based on the guidelines under SISBEN, a social program), the private sector is funded by employees and employers. Probably Colombia is the only country in LATAM with GCP (Good Clinical Practice) certification for the clinics ensuring their high standards.

 

Cardiac devices are the largest segment followed by Diagnostics and then Ortho products. More than 80 % (82% as per one estimate) of the medical devices are imported!! Local production is mainly for lower-end products. Colombia has a free trade agreement with the EU and Canada making imports from there easier.

 

The market is competitive and the major part is by the Government seeking the lowest price through tenders, many times through open negotiable tenders, pushing the prices lower. There is an agreement with the USA also (US-Colombia Trade Promotion Agreement, or CTPA) adding to the competition from the American companies.

 

Opportunities and Challenges

 

Large size, with a predictable registration framework and strong economy, make the market attractive. More than 80% of the supplies of devices are through imports. A stable and predictable market with a volume suggests taking the market seriously for the future.

 

Price competition from the EU, the USA and Canada may act as a major challenge.

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