|
 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 partners
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. |
