Colombia Overview of Regulatory Framework for In Vitro Diagnostic (IVD) Devices
Colombia Overview of Regulatory Framework for In Vitro Diagnostic (IVD) Devices - All Classifications
Regulatory Background
Overview of the Regulatory System
In Vitro Diagnostic (IVD) reagents are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Food and Drug Surveillance Institute, or INVIMA) in Colombia. The regulatory framework for IVD reagents is based on Decree 3770/2004, amended by Decree 4124/2008 and Decree 581/2017. Other IVD devices (e.g., instruments or analyzers) fall under the conventional medical device regulatory framework of Decree 4725/2005. All IVD reagents require registration with INVIMA. An "automatic registration" pathway is available for low risk (category I and Il) MDs, whereby registration is automatically granted upon submission of required documents. Category Ill IVDs require pre-market approval and may require additional approval from the Specialized Board for IVDs.
Home Country Approval
IVDs must have a valid Certificate of Free Sale (CFS) from the country of origin.
Reference Country Approval
It is not possible to directly leverage a reference country approval for IVD registration in Colombia; however, category Ill IVDs with a valid CFS from the United States of America (USA), European Union (EU), Canada, Japan, or Australia do not require additional review by the Specialized Board, which may shorten the time to approval.
Is my product regulated?
Definition of an IVD
The definition of "in vitro diagnostic reagent" is offered in Article 2 of Decree 3770/2004 as follows (unofficial translation):
In vitro diagnostic reagent: A reagent product, calibrator, or control material, used alone or in combination, intended by the manufacturer to be used for the in vitro examination of specimens from the human body, including blood donations and tissues/organs, primarily in order to provide information related to:
Physiology or pathology.
Congenital anomalies.
The determination of the safety and compatibility with potential [transplant] recipients.
Monitoring of therapeutic measures.
Certain IVD reagents are exempt from registration, as specified in Decree 1036/2018. These include research use only (ROU) reagents or analytical reagents for laboratory use only.
Classification and Grouping
How are devices classified?
Classification of IVDs is addressed in Article 3 of Decree 3770/2004. IVDs are classified into three tiers according to potential risk, with ascending risk assigned to category l, Il, and Ill. The risk classification of IVDs is as follows:
Category Ill: IVD reagents with any of the following characteristics:
Used for the screening of communicable diseases in donors of blood, blood components, and other tissues/organs for transplantation.
Used to ensure immunological compatibility of blood and other tissues/organs for transplant.
Used for diagnosis of communicable diseases of high risk or danger to life in the general population, including rapid tests.
Category Il: IVD reagents related to the following areas:
Molecular biology.
Endocrinology.
Toxic-Pharmacology.
Blood chemistry.
Hematology.
Immunology.
Microbiology.
Coproparasitology.
Coagulation.
Blood gases.
Urine analysis.
Immunohematology tracking cells.
Self-diagnosis and self-control tests.
Category l: Reagents for the following uses:
Culture media.
Coloring materials.
Diluent solutions, buffers, and lysing agents.
Washing solutions.
IVD reagents with intended use not specifically related to the uses outlined in category I or Ill would be considered category ll. Four additional IVD classification rules are included in Article 4 of Decree 3770/2004.
Grouping
Category I and Il IVDs can be grouped with up to 15 IVDs included in a single registration, per Article 11 of Decree 3770/2004. Grouped IVDs must have the same risk classification, belong to the same area, and have the same manufacturer. Grouping criteria are not specified for category Ill IVDs.
Since IVD instruments and analyzers are regulated as traditional medical devices, they cannot be registered as systems with corresponding IVD reagents.
Publicly Accessible Database
Registered IVDs are listed in the INVIMA Registros Sanitarios database and can be used for classification and competitor analysis.
Software
The regulations of Decree 3770/2004 are applicable to IVD reagents only; software is regulated by the medical device regulations of Decree 4725/2005.
Language
Official LanguageThe official language of Colombia is Spanish.
Translation Requirements
Spanish translations must be provided for most documents. Technical documents such as the test reports can be provided in any language with a summary in Spanish, but INVIMA may request a full translation, if necessary.
Primary Market Operators
Manufacturer
Manufacturers must have valid Good Manufacturing Practice (GMP) certification, per Title Il of Decree 3770/2004. Manufacturers share in post-market surveillance and vigilance activities.
In-Country Representative
In Colombia, a local entity must submit the application for device registration and liaise with Colombian authorities on behalf of the manufacturer. This could either be a legal representative (must be a lawyer with Power of Attorney from the manufacturer), a duly appointed importer (with a Letter of Authorization (LOA) from the manufacturer), or a third party authorized to apply for the registration. Unlike many other countries, manufacturers registering through a legal representative typically maintain control over their registrations and can issue Power of Attorney to any other entity and change representatives without the cooperation or consent of the prior representative. However, it is important to note that the manufacturer must be listed as the registration owner in the application. If a manufacturer registers through their importer, the importer will likely own the registration and therefore must consent to changes, including transfers (Importers often include ownership of the registration within the terms of the LOA). It is also possible for a product to have more than one simultaneous approval held by different entities.
Importer
Importers must have a Certificate of Storage and Conditioning Capacity (CCAA) for IVD reagents issued by INVIMA, as per Resolution No. 132 of 2006. Note that the CCAA for IVD reagents is different than the CCAA for medical devices. Importers are listed in the device registration, and more than one importer can be listed on the same device registration. Importers share in post-market surveillance and vigilance responsibilities.
Distributor
IVD distributors must also be licensed by INVIMA and have a CCAA for IVD reagents issued by INVIMA, as per Resolution No. 132 of 2006. If the distributor is not the importer, then the distributor as well as the importer must be listed in the device registration. Distributors also share in post-market surveillance and vigilance responsibilities.