Colombia Overview of Regulatory Framework for Medical Devices

Colombia Overview of Regulatory Framework for Medical Devices

Regulatory Background

Overview of the Regulatory System

Medical devices are controlled by the National Food and Drug Surveillance Institute (INVIMA - institute National de Vigilancio de Medicarnentos y Alimentos] in Colombia. The regulatory framework is based on Decree 4725/2005 (and amendments). Other medical device regulatory documents are available on the INVIMA website. Products that meet the characteristics of a medical device must be registered with INVIMA prior to commercialization. An "automatic registration" pathway is permitted for low-risk devices, whereby registration Is automatically granted upon submission of required documents. High-risk devices are subject to pre-market approval.

Home Country Approval

Home-country approval or approval from one of the countries listed in Article 29 of Decree 4725/2005 (Global Harmonization Task Force (GHTF) founding members) is a prerequisite to authorization in Colombia.

Reference Country Approval

Decree 3275/2009, which amends Article 18 of Decree 4725/2005, reduces the registration requirements of Class I, Ila, Ilb medical devices that are not Controlled, allowing for the submission of a Certificate of Free Sale (CFS) from a GHTF founding-member as a substitute for certain requirements of the normal registration. Per Article 2 of the Decree 3275/2009, the CF5 must be less than one year old at the time of the application submission.

Is my product regulated?

Definition of a Medical Device

The definition of a medical device is offered in Article 2 of Decree 4725/2005 and is similar to the European Union (EU)/GHTF definitions. An unofficial translation of "medical device" is as follows:

A medical device for human use is an instrument, apparatus, machine, software, biomedical equipment or any other similar article, used alone or in combination, including its components, parts, accessories and computing programs that intervene in Its correct application, intended by the manufacturer for use to :

• Diagnosis, prevention, supervision, treatment, or relief of disease.

• Diagnosis, prevention, supervision, treatment, or relief of an injury or deficiency.

• The investigation, substitution, modification, or support of the anatomic structure or physiologic process.

• Pregnancy diagnosis and conception control.

• Care during pregnancy, the birth, or after it, including care of the newly born.

• Disinfection and/or sterilization of medical devices.

For borderline products, INVIMA will occasionally issue regulatory updates to clarify which products are exempt from registration, such as those products included in Circular Letter No. 500-3479-14 and Camisidn net/Isere Sala Especializada De Disposirivos Medicos Y Product°, Varios, Acta No. 3 01201.3. (See 'Importation" section for further discussion on products exempt from registration).

Classification and Grouping

How are devices classified?

Medical devices are classified according to risk in a four-tiered system with increasing risk assigned to Classes I, Ila, 1lb, and Ill. Classification is determined by applying 18 rules offered in Chapter II of Decree 4725/2005, similar to EU/GHTF systems. Classifications In Colombia almost always follow the EU classification. Devices are further divided into two categories of "Controlled" and "Non-Controlled" devices. Controlled devices are defined in Article 2 of Decree 4725/2005 as follows:

Controlled technology biomedical equipment.- those medical devices subject to special control, for being included in any of the following situations:

a) In accordance with its classification of high risk and the degree of vulnerability associated with these devices; as well as the derivatives of the design, manufacture, installation, management and its Intended destination;

b) The prototypes that lead to new scientific and technological developments;

c) Those that are subject to the control of the offer through the use of standards that allow the efficient distribution of the technology, by geographic zones in the country, according to the parameters of article 65 of Law 715 of 2001;

d) That corresponds to used or re-powered equipment;

e) That for their acquisition, installation, and use they require an investment superior to the 700 minimum legal salaries in force, they are classified Ilb and 111 according to what is established in this decree and they are under the parameters of article 65 of Law 715 of 2001.

The Ministry of Social Protection may. through an administrative act, classify as biomedical equipment of controlled technology, in addition to those enunciated in this article, the equipment of classes I and ila provided in this decree, when the needs of the Sector so require it.

In practice, Class I and lie devices generally fall under the Non-Controlled category, while higher classes can be of the Controlled category if they have the characteristics of biomedical equipment mentioned in Article 2 of the Decree active hospital equipment for monitoring vital signs). it is possible for some low-risk devices to be categorized as Controlled, but that designation is ultimately at the discretion of the Ministry.

Manufacturers (through a local representative) can submit an official inquiry to INVIMA to confirm their device classification.

Grouping

Grouping criteria are addressed in Circular 500-1298-2013. Accordingly, products that share the following features may be grouped under a single registration,

• Same risk class

• Same indications for use

• Same generic name

• Same manufacturer

Additionally, products can be grouped as kits or systems.

Publicly Accessible Database

Registered devices are listed in the INVIMA Registros Sanitarios database and can be used for competitor analysis. The sanitary registry can be searched for medical devices by product name or registration number. Product listings in the sanitary registry include device classification, commercial presentation, and intended use.

Software

Standalone software with an intended purpose that meets the medical device definition is subject to registration. Software as a medical device still requires a licensed importer/distributor to be named in the registration application, even if the software is not physically imported into Colombia.

Language

Official Language

The 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

Per Article 2 of Decree 4725, the manufacturer is the natural or legal person responsible for the design, manufacture, packing, packaging, and labeling of a medical device. Manufacturers must have valid Good Manufacturing Practice (GMP) certification. Manufacturers share in post-market surveillance and vigilance activities (see "Post-Market Surveillance" section).

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) of medical devices issued by INVIMA, per Article 10 of Decree 4725/2005. Importers are listed in the device registration, and more than one importer can be listed on the same device registration. Importers must ensure traceability of their medical devices by maintaining a distribution map, as specified in Article 63 of Decree 4725/2005. Importers also share in post-market surveillance and vigilance responsibilities (see "Post-Market Surveillance" section).

Distributor

Medical device distributors must also be licensed by INVIMA and have a CCAA. If the device distributor is not the importer, then the distributor as well as the importer must be listed in the device registration. Distributors must ensure traceability of their medical devices by maintaining a distribution map, as specified in Article 63 of Decree 4725/2005. Distributors also share in post-market surveillance and vigilance responsibilities (see "Post-Market Surveillance" section).