Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. 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. We maintain a local presence in Colombia Colombia-Latin America We are incorporated both in the US and in Colombia. We have the resources and expertise to serve as your local legal representative in order to bring your product to market in Colombia. Acting as your independent legal representative, we can focus fully on Colombian regulatory affairs and how they affect your product registration, as well as to assign Colombian distributors based on your sales and marketing requirements. INVIMA requires foreign manufacturers to name one importer of record —an entity certified by INVIMA to store medical products— in their registration application. However, if you choose your distributor as your importer of record, you will be limited to having only one distributor in Colombia —as opposed to having several ones that will cover the whole country. It is advisable that foreign manufacturers choose third-party logistics operators as their importer of record. This third-party will be able to import and store your product in its INVIMA-certified warehouse in Colombia. Upon your instructions, the third-party will ship your products to the local distributor of your choice. By having a third-party as your importer of record, you will be able to have several distributors in Colombia —they place an order with you, and the third-party will ship the products domestically to your distributor's preferred destination in Colombia. Interventional Concepts can help you find an INVIMA-certified third-party logistics operator in Colombia that can act as your importer of record. It is important to choose a reputable distributor when entering the Colombian market, as the wrong one can lead to missed sales opportunities, poor relationships with end users and a damaged brand name. Working with experienced consultants ensures that distributors are chosen objectively and evaluated with your specific business needs in mind.

1. S T E P S T O R E G I S T E R A M E D I C A L
D E V I C E
C L A S S I F I C A T I O N
9
1 Instituto Nacional de Vigilancia de Medicamentos y Alimentos
(INVIMA) is the medical device regulator in Colombia. Colombia
follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class
III) that is similar to the classification scheme used in Europe.
C E R T I F I C A T E O F F R E E S A L E
3 Provide a Certificate of Free Sale (CFS) or Certificate to Foreign
Government (CFG) to demonstrate that your device can be legally
sold in your home market or Australia, Canada, the European
Union, Japan or the US.
Q U A L I T Y S Y S T E M
4 Provide proof of quality system compliance, such as an ISO 13485
certificate or proof of FDA QSR compliance. Prepare registration
application dossier including detailed device information.
T E S T R E P O R T S
5 Provide test reports for Class IIa, IIb, and III devices. Provide clinical
data for Class IIb and III devices.
T R A N S L A T I O N S & S U B M I S S I O N
6 Your Colombia legal representative translates legal and technical
documents to Spanish. submits your application dossier to INVIMA
and manages your medical device registration in Colombia. Pay
application fee to INVIMA.
A P P R O V A L
7 INVIMA automatically approves Class I and IIa applications, so you can begin
selling right away. The agency will still review the application, and manufacturers
must respond to any additional information requests within 30 days. For Class IIb
and Class III, INVIMA must review and approve your application before you can
begin selling; the review could take 4-6 months. During this review, they may ask
follow-up questions or request additional information.
R E G I S T R A T I O N C E R T I F I C A T E
8 Once approved, INVIMA will issue the registration certificate. Your
registration certificate will be held by your legal representative in
Colombia.
M A R K E T
9 You may begin marketing your device in Colombia. Registrations
are valid for 10 years. Application renewals are due to INVIMA three
months before the expiration of your registration certificate.
L E G A L R E P R E S E N T A T I V E
2 Appoint a legal representative who will submit your registrations to INVIMA. If you
appoint a distributor, it may list itself as the owner of the registration. If you
appoint a regulatory legal representative, it will manage your registration process,
but you will retain ownership and maintain control of the registration.
COLOMBIA
N O T E S
Irrespective of whether the registration is submitted via a legal representative or not, the manufacturer must appoint a licensed importer of record in the registration.
Registrations will not be accepted without a valid importer named. This is a simplified overview of the process. INVIMA may choose to audit your submission and request
more documents, which will add time to your approval. The time frames shown above are typical for the majority of medical device submissions but assume that your
device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of
your technical documentation and how much time you take to address additional information requests from INVIMA after submission. YOUR SUBMISSION(S) MAY TAKE
MORE TIME THAN WHAT IS SHOWN ABOVE. Registrations remain valid for the time specified as long as you do not make changes to the device, intended use or indications
for use. Renewal documents are due to INVIMA three months prior to the expiration of the current registration certificate. We recommend starting the re-registration
process no later than the time period specified above to avoid any lapse in your registration. Translation fees are excluded from submission pricing and will be invoiced
separately. More information at www.colombiamarketaccess.com.
COLOMBIAMARKETACCESS.COM