Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. 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 will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.

1. Medical Device (Class I, IIa, IIb, III) Registration Requirements
COLOMBIA, INVIMA
Technical Requirements
1 Certificate of good manufacturing practice (GMP) and/or certificate of storage and conditioning and/or certificate of technical and sanitary requirements.
2 Medical product description. It includes indications of use, composition, side effects, contraindications, warnings, main components, accessories, relation to
patients, etc.
3 Technical studies and analytical checks. It includes the following:
A. Summary of design verification & validation documents (test report during the manufacturing process)
B. Certificate of analysis (CoA) of the finished product. The CoA must include document name, company name, name of product under evaluation,
date, batch tests, lot description and/or number(s), quantitative results, conclusion and signature of the responsible person.
C. Analysis certificate containing specifications, indicating acceptance values or ranges (it is required to establish that the design complies with the
standards and current technical regulations specific to them).
4 Declaration of conformity (CoF) issued and signed by the manufacturer compliant with the international reference standards it meets, on which the name of
the medical product becomes apparent, if not already on the certificate of free sale.
5 Sterilization method. It must include the method of enunciation, the reference standard which it is based on and the studies carried out. If the sterilization
method is carried out with ethylene oxide, you must attach the studies that demonstrate the residue after sterilization of the product.
6 Disposal method description or final disposition of the medical device issued by the manufacturer. It must state that the manufacturer would abide by the
Colombian waste disposal regulations.
7 Complete shelf life studies:
A. This requirement is met by annexing the stability studies that allow the validation of the shelf life attributed to the medical device, attaching summary
of the method, verification, validation and final result.
B. For sterile medical devices coming from the factory, included in product registration application, this requirement is met by annexing the stability
studies that allow the validation of the attributed shelf life, attaching summary of the method, verification, validation and final result.
8 Original labels artwork (inserts when applicable).
A. Manufacturer's labels artwork. They must at least include the following:
a. Product name or reference
b. Manufacturer's name and address
c. Internationally recognized safety symbols.
B. The local distributor in Colombia must attach a label on the product with the following information: (INVIMA ​must see this artwork at the time of
submission)
LATAM Market Access Inc. | ​www.latammarketaccess.com​ | Page 1 of 2

2. Medical Device (Class I, IIa, IIb, III) Registration Requirements
a. Product name
b. Product reference and/or model
c. Importer's name and address
d. Product registration number (I, IIA, IIB y III)
9 Scientific information supporting the safety of medical devices class I, IIa, IIb, and III
A. For medical products in direct contact with patients:
a. Product biological evaluation tests (studies of cytotoxicity, systemic toxicity, pyrogenicity, sensitization, irritation or intracutaneous reactivity,
genotoxicity, allergenicity, haemocompatibility and carcinogenicity), in addition to the summary of the studies and tests carried out.
B. For sufficiently proven technologies:
a. Scientific evidence that is indexed or published on internationally recognized journals in which the biological evaluation of the material is
stated.
10 Risk analyses issued by the manufacturer for medical devices class IIa, IIb, and III, mentioning the risks detected during the design and manufacture, as well
as causes, severity, occurrence, detectability, solutions proposed for the mitigation of each one of them.
11 List of standards used.
12 Commercial history of the medical product issued by the manufacturer, referencing some of the countries where the product is being marketed and sold to,
and any worldwide health alerts involved with the product.
13 Clinical studies in patients to demonstrate safety and effectiveness. For class IIb, III, published clinical studies of similar or equivalent technologies can be
submitted.
Legal Requirements
14 Certificate of free sale (it ​must be apostilled). It must be current (dated within 12 months prior to submission), at least, have the full product name, its
components, and be consistent with information included in all of your technical files.
15 Importer's authorization.
16 Power of attorney.
Source: ​ABC de Dispositivos Médicos, INVIMA, 2013
LATAM Market Access Inc. | ​www.latammarketaccess.com​ | Page 2 of 2