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Colombia authorises parallel imports of certain medical devices

This article was originally published in RAJ Devices

Executive Summary

Colombia's health ministry says it is aiming to complete by year-end the implementation of regulations that allow manufacturers and importers to parallel import certain medical devices into the country without having to register them with the national healthcare products regulatory agency, INVIMA1.

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Medical device regulation in Colombia: an evolving market

Daniel Ricardo Torres explains how to register and sell medical devices in Colombia.

Colombia's regulatory system for medical devices is characterised by a complete set of regulatory controls that covers both pre-market and post-market activities.

As is the case of the other Latin American countries that have implemented medical device regulations, Colombia's system is influenced by the guidelines of the World Health Organization and the Pan American Health Organization, which recommend use of Global Harmonization Task Force parameters and the experience of the regulatory models of certain developed countries such as the US and the EU.

The Colombian regulatory system is also characterised, however, by lengthy review times. But the system is evolving and the country has been taking steps to make it easier for companies to register their products.

Investment incentives

Imports of medical devices in Colombia between 2005 and 2009 increased at a compound growth rate of 18%, reaching a total of US$689 million1. Exports during the same period were lower, registering a compound growth rate of 15% and reaching a total of US$93 million.

Colombia's medical device industry is clustered mainly around the country's capital, Bogot�, which boasts as an investment incentive a free trade zone.

Trade agreements signed by the Colombian government mean that companies located in Bogot� have preferential access to the most important markets in Latin America, where the value of the medical device sectors has been estimated at around US$8 billion and is growing.

INVIMA and the legislation

INVIMA, Colombia's National Institute of Food and Drug Monitoring (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), is responsible for the inspection, surveillance, health monitoring and quality control of medical devices, in vitro diagnostics, drugs and biologics, among other products.

INVIMA's Sub-directorate of Healthcare Registers division (Subdirecci�n de Registros Sanitarios) is in charge of pre-market approvals of new medical devices. The institute's Sub-directorate of Health Supplies and Other Products division (Subdirecci�n de Insumos para la Salud y Productos Varios) conducts surveillance activities, including post-market vigilance activities and the granting of good manufacturer practice certificates.

Decree 4725/2005 covers pre- and post-market requirements for medical device manufacturers and importers. For example, it includes provisions for activities such as GMP and medical device surveillance and vigilance. The publication of the decree in 2005 marked the first time that the concept of "medical device" had been introduced in the Colombian regulatory system and it represented a major step towards global harmonisation on the medical technology front.

Definition and four risk classes

The definition of medical device in Colombia is similar to that of the GHTF and of the EU Medical Devices Directive, Directive 93/42/EEC:

A medical device is any instrument, apparatus, machine, software, biomedical equipment, or other similar or related article, whether used alone or in combination, including the components, parts, accessories and software, necessary for its proper application intended by the manufacturer to be used for the purpose of: a) diagnosis, prevention, monitoring, treatment or alleviation of disease; b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; c) investigation, replacement, modification, or support of the anatomy or of a physiological process; d) diagnosis of pregnancy and control of conception; e) care during pregnancy, birth, and postpartum, including newborn care; f) disinfection or sterilization of medical devices.

IVDs are not regulated under Decree 4725/2005 (more details below). Medical devices are categorised into one of four classes based on their risk (and on the GHTF classification rules). Classes I and IIa medical devices are considered low- and medium-risk and their registration is automatic – ie registration can be granted within 48 hours. Classes IIb and III devices are considered higher risk and their registration involves a more rigorous pre-market procedure.

Automatic and regular registrations

All medical devices in Colombia must be registered with INVIMA. A registration is valid for ten years, after which it may be renewed. Renewal involves submitting an application that meets the requirements of the original application, although technical documents that have already been sent to the institute and that have not changed do not have to be submitted.

Foreign companies can apply for product registration themselves, but they need a local importer for the process, who is responsible for distributing the medical device in Colombia.

Registrations can be modified by their owners in cases where no major changes have been made to the device. For example, owners can add new references or models and new manufacturing plants. Or they can change the authorised importer or the labelling, etc.

INVIMA has the power to review any registration and suspend or cancel it if the device causes serious adverse effects to patients.

Automatic registration applies to Class I and IIa medical devices and can be granted within 48 hours after an application has been submitted.

Around a month after INVIMA has granted an automatic registration, it conducts an in-depth evaluation of the relevant documents to verify the safety of the device (in Spanish, this is known as the Control Posterior). At this stage, INVIMA might ask for additional information. Failure to submit the required documents might result in a registration being suspended or even cancelled.

Regular registration applies to Class IIb and III medical devices. According to INVIMA, this registration process could take one or two months. However, if the institute requires additional information to evaluate the safety and effectiveness of the device, the process can take as long as eight or nine months.

Document requirements

Documents that must be included in an application to register a medical device are established in Articles 18, 19, 24 and 29 of Decree 4725/2005. Table 1 provides an outline of the documents that manufacturers or importers must submit to the competent authority in support of their application.

Manufacturers seeking medical device registration must have a GMP certification for their production plant. However, the Colombian government has not yet established the parameters or standards for this purpose. Meanwhile, other GMP certifications are valid such as the International Organization for Standardization certification, ISO 13485.

Importers based in Colombia must obtain a Storage and Conditioning Certification (Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA)). According to Resolution 4002/2007, importers must fulfil parameters regarding human resources, infrastructure, hygienic conditions, quality system, documents, equipment, tracking of products and vigilance in order for INVIMA to grant the CCAA.

Regarding the finer points of some of the registration items listed in Table 1, the form must contain basic information relating to the manufacturer, importer and the product such as name, trade mark, risk classification and indications. The form is available on the INVIMA website2.

The description of the medical device must comprise features of the product, including the device's indications, instructions for use, parts, components, composition, warnings and contraindications. The technical studies and analytical test item relate to all evaluations performed that concern the device's features, ie dimensional, mechanical, physical, chemical or microbiological properties. They must contain the results and acceptance range. Applicants are advised to also include the standard used. Sterile devices must describe the sterilisation process used. Devices that pose a risk to the environment after their use must indicate the disposal method.

Regarding product safety information, this concerns biocompatibility tests, electrical safety tests or other safety tests relevant to the device's features and to international standards. The risk analysis can correspond to ISO 14971 – application of risk management to medical devices – or any other similar standard.

Applicants must submit a list of all the standards that were used during the design, development and manufacture of their device.

The clinical studies item corresponds to any clinical trial in which the safety and effectiveness of the device is evaluated. These studies can relate to a device with a different trademark, as long as that device has the same features of the device for which registration is being sought.

As for the certificate of free sale, this must be drawn up by the competent authority of the country in which the device is manufactured. If the device is not sold in the country in which it is manufactured, it is possible to submit a free sale certificate issued by one of the following countries: the US, the EU, Japan, Australia or Canada. This document must have an apostille stamp, ie a certification of authenticity.

The commercial history item should comprise a brief sales review for the device, listing in which countries the device is sold and mentioning whether the product has been subject to a recall or withdrawal.

A document that authorises the distribution, importation and sale of a device in Colombia must be drawn up by the manufacturer.

Labelling and vigilance

As for labelling requirements, INVIMA accepts labels in the original language. The information contained therein must be clear (Articles 54 and 55 of Decree 4725/2005) and must include details such as the name of the device, trademark, manufacturer, expiry date and special information, eg "one use only" or "sterile" and storage conditions. Labelling information may be accompanied by symbols of international recognition.

Manufacturers or importers may adapt their labels by placing stickers on the original label but they must be careful not to hide important information. The sticker must contain the registration number, the importer's data and any other important information.

Instructions for use, contraindications and warnings, etc, must be in Spanish and must be legible and understandable.

Medical device surveillance in Colombia is conducted under the Medical Device Vigilance National Programme (Programa Nacional de Tecnovigilancia), which is led by INVIMA. Resolution 4816/2008 established the parameters of the programme and defines the responsibilities of manufacturer and importers.

All device manufacturers and importers must notify INVIMA of any adverse event reported during the marketing or use of their products. Notification must include any adverse events that have occurred worldwide. INVIMA must be notified of serious adverse events or serious adverse incidents within 72 hours of the event or incident. Non-serious adverse events and non-serious adverse incidents must be compiled and submitted every three months.

A different framework for IVDs

Colombia has a different legal framework for the registration of IVDs. Decree 3770/2004 establishes the requirements for IVD registration and surveillance. The decree describes three different IVD risk categories: Classes I, II and III. Class I covers low-risk IVDs and includes growth medium, histological stains and buffer solutions. Class II comprises medium-risk IVDs and includes most of the IVDs that are used to measure parameters relating to such things as chemistry, immunology and to detect hormones and toxins, etc. Class III IVDs are high-risk products and include certain reagents used in the diagnosis of epidemiologically relevant diseases such as HIV, hepatitis B and tropical diseases. Class III IVDs also include reagents used in blood donation tests and in tissue organ donation tests.

The registration process for IVDs is similar to that for medical devices, but there are some differences. An automatic registration (Class I and II) is valid for ten years, while a regular registration (Class III) is valid for only five years.

An evolving framework

INVIMA and the Ministry of Health are continuously revising the healthcare regulation to ensure it meets the needs of the public health as well as those of the industry. The ministry is working on the development of the guidelines for GMP certification for medical devices and for certain custom-made medical devices such as external prosthetics, hearing aids, glasses and visual-ocular devices.

It is important to mention that Decree 3275/2009, which took effect in August 2009 and amends Article 18 of Decree 4725/2005, reduces requirements for the registration of Class I, IIa and IIb devices. The decree made it possible for INVIMA to accept certificates of free sale issued by one of the reference countries (ie the US, the EU, Japan, Australia and Canada) in place of certain information that companies were previously required to submit, namely information relating to technical studies and analytical test, sterilisation processes, disposal methods and clinical studies.

References

1. Invest in Bogot�, website accessed 14 September 2010, http://english.investinbogota.org/medicaldevices

2. INVIMA formulary, http://web.invima.gov.co/portal/documents/portal/documents/root/Formularios/formatos_dispositivosmed%20Revisado.xls

Daniel Ricardo Torres, MD, MSc, teaches medical device regulation at the Universidad Nacional Abierta y a Distancia, in Bogot� DC, Colombia. Email:daniel.torres@unad.edu.co.

Medical device regulation in Colombia: an evolving market

Daniel Ricardo Torres explains how to register and sell medical devices in Colombia.

Colombia's regulatory system for medical devices is characterised by a complete set of regulatory controls that covers both pre-market and post-market activities.

As is the case of the other Latin American countries that have implemented medical device regulations, Colombia's system is influenced by the guidelines of the World Health Organization and the Pan American Health Organization, which recommend use of Global Harmonization Task Force parameters and the experience of the regulatory models of certain developed countries such as the US and the EU.

The Colombian regulatory system is also characterised, however, by lengthy review times. But the system is evolving and the country has been taking steps to make it easier for companies to register their products.

Investment incentives

Imports of medical devices in Colombia between 2005 and 2009 increased at a compound growth rate of 18%, reaching a total of US$689 million1. Exports during the same period were lower, registering a compound growth rate of 15% and reaching a total of US$93 million.

Colombia's medical device industry is clustered mainly around the country's capital, Bogot�, which boasts as an investment incentive a free trade zone.

Trade agreements signed by the Colombian government mean that companies located in Bogot� have preferential access to the most important markets in Latin America, where the value of the medical device sectors has been estimated at around US$8 billion and is growing.

INVIMA and the legislation

INVIMA, Colombia's National Institute of Food and Drug Monitoring (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), is responsible for the inspection, surveillance, health monitoring and quality control of medical devices, in vitro diagnostics, drugs and biologics, among other products.

INVIMA's Sub-directorate of Healthcare Registers division (Subdirecci�n de Registros Sanitarios) is in charge of pre-market approvals of new medical devices. The institute's Sub-directorate of Health Supplies and Other Products division (Subdirecci�n de Insumos para la Salud y Productos Varios) conducts surveillance activities, including post-market vigilance activities and the granting of good manufacturer practice certificates.

Decree 4725/2005 covers pre- and post-market requirements for medical device manufacturers and importers. For example, it includes provisions for activities such as GMP and medical device surveillance and vigilance. The publication of the decree in 2005 marked the first time that the concept of "medical device" had been introduced in the Colombian regulatory system and it represented a major step towards global harmonisation on the medical technology front.

Definition and four risk classes

The definition of medical device in Colombia is similar to that of the GHTF and of the EU Medical Devices Directive, Directive 93/42/EEC:

A medical device is any instrument, apparatus, machine, software, biomedical equipment, or other similar or related article, whether used alone or in combination, including the components, parts, accessories and software, necessary for its proper application intended by the manufacturer to be used for the purpose of: a) diagnosis, prevention, monitoring, treatment or alleviation of disease; b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; c) investigation, replacement, modification, or support of the anatomy or of a physiological process; d) diagnosis of pregnancy and control of conception; e) care during pregnancy, birth, and postpartum, including newborn care; f) disinfection or sterilization of medical devices.

IVDs are not regulated under Decree 4725/2005 (more details below). Medical devices are categorised into one of four classes based on their risk (and on the GHTF classification rules). Classes I and IIa medical devices are considered low- and medium-risk and their registration is automatic – ie registration can be granted within 48 hours. Classes IIb and III devices are considered higher risk and their registration involves a more rigorous pre-market procedure.

Automatic and regular registrations

All medical devices in Colombia must be registered with INVIMA. A registration is valid for ten years, after which it may be renewed. Renewal involves submitting an application that meets the requirements of the original application, although technical documents that have already been sent to the institute and that have not changed do not have to be submitted.

Foreign companies can apply for product registration themselves, but they need a local importer for the process, who is responsible for distributing the medical device in Colombia.

Registrations can be modified by their owners in cases where no major changes have been made to the device. For example, owners can add new references or models and new manufacturing plants. Or they can change the authorised importer or the labelling, etc.

INVIMA has the power to review any registration and suspend or cancel it if the device causes serious adverse effects to patients.

Automatic registration applies to Class I and IIa medical devices and can be granted within 48 hours after an application has been submitted.

Around a month after INVIMA has granted an automatic registration, it conducts an in-depth evaluation of the relevant documents to verify the safety of the device (in Spanish, this is known as the Control Posterior). At this stage, INVIMA might ask for additional information. Failure to submit the required documents might result in a registration being suspended or even cancelled.

Regular registration applies to Class IIb and III medical devices. According to INVIMA, this registration process could take one or two months. However, if the institute requires additional information to evaluate the safety and effectiveness of the device, the process can take as long as eight or nine months.

Document requirements

Documents that must be included in an application to register a medical device are established in Articles 18, 19, 24 and 29 of Decree 4725/2005. Table 1 provides an outline of the documents that manufacturers or importers must submit to the competent authority in support of their application.

Manufacturers seeking medical device registration must have a GMP certification for their production plant. However, the Colombian government has not yet established the parameters or standards for this purpose. Meanwhile, other GMP certifications are valid such as the International Organization for Standardization certification, ISO 13485.

Importers based in Colombia must obtain a Storage and Conditioning Certification (Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA)). According to Resolution 4002/2007, importers must fulfil parameters regarding human resources, infrastructure, hygienic conditions, quality system, documents, equipment, tracking of products and vigilance in order for INVIMA to grant the CCAA.

Regarding the finer points of some of the registration items listed in Table 1, the form must contain basic information relating to the manufacturer, importer and the product such as name, trade mark, risk classification and indications. The form is available on the INVIMA website2.

The description of the medical device must comprise features of the product, including the device's indications, instructions for use, parts, components, composition, warnings and contraindications. The technical studies and analytical test item relate to all evaluations performed that concern the device's features, ie dimensional, mechanical, physical, chemical or microbiological properties. They must contain the results and acceptance range. Applicants are advised to also include the standard used. Sterile devices must describe the sterilisation process used. Devices that pose a risk to the environment after their use must indicate the disposal method.

Regarding product safety information, this concerns biocompatibility tests, electrical safety tests or other safety tests relevant to the device's features and to international standards. The risk analysis can correspond to ISO 14971 – application of risk management to medical devices – or any other similar standard.

Applicants must submit a list of all the standards that were used during the design, development and manufacture of their device.

The clinical studies item corresponds to any clinical trial in which the safety and effectiveness of the device is evaluated. These studies can relate to a device with a different trademark, as long as that device has the same features of the device for which registration is being sought.

As for the certificate of free sale, this must be drawn up by the competent authority of the country in which the device is manufactured. If the device is not sold in the country in which it is manufactured, it is possible to submit a free sale certificate issued by one of the following countries: the US, the EU, Japan, Australia or Canada. This document must have an apostille stamp, ie a certification of authenticity.

The commercial history item should comprise a brief sales review for the device, listing in which countries the device is sold and mentioning whether the product has been subject to a recall or withdrawal.

A document that authorises the distribution, importation and sale of a device in Colombia must be drawn up by the manufacturer.

Labelling and vigilance

As for labelling requirements, INVIMA accepts labels in the original language. The information contained therein must be clear (Articles 54 and 55 of Decree 4725/2005) and must include details such as the name of the device, trademark, manufacturer, expiry date and special information, eg "one use only" or "sterile" and storage conditions. Labelling information may be accompanied by symbols of international recognition.

Manufacturers or importers may adapt their labels by placing stickers on the original label but they must be careful not to hide important information. The sticker must contain the registration number, the importer's data and any other important information.

Instructions for use, contraindications and warnings, etc, must be in Spanish and must be legible and understandable.

Medical device surveillance in Colombia is conducted under the Medical Device Vigilance National Programme (Programa Nacional de Tecnovigilancia), which is led by INVIMA. Resolution 4816/2008 established the parameters of the programme and defines the responsibilities of manufacturer and importers.

All device manufacturers and importers must notify INVIMA of any adverse event reported during the marketing or use of their products. Notification must include any adverse events that have occurred worldwide. INVIMA must be notified of serious adverse events or serious adverse incidents within 72 hours of the event or incident. Non-serious adverse events and non-serious adverse incidents must be compiled and submitted every three months.

A different framework for IVDs

Colombia has a different legal framework for the registration of IVDs. Decree 3770/2004 establishes the requirements for IVD registration and surveillance. The decree describes three different IVD risk categories: Classes I, II and III. Class I covers low-risk IVDs and includes growth medium, histological stains and buffer solutions. Class II comprises medium-risk IVDs and includes most of the IVDs that are used to measure parameters relating to such things as chemistry, immunology and to detect hormones and toxins, etc. Class III IVDs are high-risk products and include certain reagents used in the diagnosis of epidemiologically relevant diseases such as HIV, hepatitis B and tropical diseases. Class III IVDs also include reagents used in blood donation tests and in tissue organ donation tests.

The registration process for IVDs is similar to that for medical devices, but there are some differences. An automatic registration (Class I and II) is valid for ten years, while a regular registration (Class III) is valid for only five years.

An evolving framework

INVIMA and the Ministry of Health are continuously revising the healthcare regulation to ensure it meets the needs of the public health as well as those of the industry. The ministry is working on the development of the guidelines for GMP certification for medical devices and for certain custom-made medical devices such as external prosthetics, hearing aids, glasses and visual-ocular devices.

It is important to mention that Decree 3275/2009, which took effect in August 2009 and amends Article 18 of Decree 4725/2005, reduces requirements for the registration of Class I, IIa and IIb devices. The decree made it possible for INVIMA to accept certificates of free sale issued by one of the reference countries (ie the US, the EU, Japan, Australia and Canada) in place of certain information that companies were previously required to submit, namely information relating to technical studies and analytical test, sterilisation processes, disposal methods and clinical studies.

References

1. Invest in Bogot�, website accessed 14 September 2010, http://english.investinbogota.org/medicaldevices

2. INVIMA formulary, http://web.invima.gov.co/portal/documents/portal/documents/root/Formularios/formatos_dispositivosmed%20Revisado.xls

Daniel Ricardo Torres, MD, MSc, teaches medical device regulation at the Universidad Nacional Abierta y a Distancia, in Bogot� DC, Colombia. Email:daniel.torres@unad.edu.co.

Colombia authorises parallel imports of certain medical devices

Colombia's health ministry says it is aiming to complete by year-end the implementation of regulations that allow manufacturers and importers to parallel import certain medical devices into the country without having to register them with the national healthcare products regulatory agency, INVIMA1.

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