Medical Device Regulations in Colombia: A Comprehensive Guide

In 2023, the Medical Devices market in Colombia is expected to achieve an impressive revenue milestone of US$2.00 billion. This reflects the positive growth and promising prospects within the industry, highlighting the increasing demand for medical devices in the country. With a thriving healthcare sector and a growing emphasis on advanced medical technologies, Colombia presents a favorable landscape for the Medical Devices market to flourish. In Colombia, stringent Medical devices regulations and guidelines have been implemented to safeguard the safety, effectiveness, and quality of medical devices.

Pharmaceutical Regulations and Registration Process in Colombia

Regulatory Authority

As a renowned regulatory authority, the Colombian National Food and Drug Surveillance Institute (INVIMA) assumes the pivotal responsibility of overseeing and regulating medical devices. Functioning as a decentralized public entity under the esteemed Ministry of Health and Social Protection, INVIMA diligently strives to ensure the utmost safety, efficacy, and quality of medical devices available within the nation.

Pre-registration Requirements

While pre-registration is not obligatory, it is highly recommended to seek early guidance from INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the regulatory authority in Colombia.

Registration Process

Prior to being marketed and sold in Colombia, medical devices are required to undergo a Medical devices registration process. This process is overseen by the Colombian National Food and Drug Surveillance Institute (INVIMA), the regulatory authority responsible for ensuring compliance. The registration procedure entails submitting comprehensive documentation and evidence that establishes the medical device's safety, efficacy, and quality standards.

The registration requirements typically include:

a) Technical documentation encompasses comprehensive details regarding the medical device, including its design, intended purpose, manufacturing process, and labelling services.

b) In the case of higher-risk devices, the submission of clinical data may be necessary to establish the device's safety and efficacy.

c) Manufacturers are obligated to adhere to international quality management system standards, such as ISO 13485, ensuring the implementation of a robust quality management system.

d) INVIMA may carry out inspections of the manufacturing site to verify compliance with Good Manufacturing Practices (GMP). These inspections serve to ensure adherence to stringent quality control measures during the device's production.

Classification System

Colombia utilizes a risk-based classification system for medical devices, which closely aligns with the International Medical Device Regulators Forum (IMDRF) framework. To determine the classification, Colombia considers various factors, including duration of use, invasiveness, and contact with the body, in order to assess the potential risks associated with the device.

The classification categories in Colombia are as follows:

a) Class I: This category encompasses low-risk devices, such as bandages, non-invasive instruments, and non-sterile gloves.

b) Class IIa: Devices with a moderate level of risk fall into this category. It includes certain surgical instruments, diagnostic devices, and reusable syringes.

c) Class IIb: Higher-risk devices, including implantable devices, specific types of catheters, and high-risk diagnostic devices, are classified under this category.

d) Class III: This is the highest-risk category, comprising devices that pose a significant risk to patients, such as life-supporting or life-sustaining equipment.

Legal Representation

In order to comply with the regulatory requirements in Colombia, medical device manufacturers are required to appoint an authorized legal representative within the country. This representative plays a crucial role as the intermediary between the company and the regulatory authorities.

Labelling Requirements

In Colombia, it is a regulatory requirement for medical device manufacturers to provide clear and accurate labelling for their products in Spanish. This ensures that healthcare professionals, patients, and end-users can effectively understand and utilize the devices. The labelling should encompass essential information such as the intended use of the device, detailed instructions for proper usage, important precautions, notable warnings, and the manufacturer's contact information.

Clinical Trial Requirements

Clinical trials may be necessary to establish the safety and effectiveness of high-risk medical devices in Colombia. However, lower-risk devices may not require clinical trials but must still provide adequate clinical evidence to support their safety and efficacy.

Testing Requirements

When it comes to promoting your medical device in Colombia, it is important to undergo the registration process with the National Food and Drug Surveillance Institute (INVIMA), the regulatory authority responsible for medical devices in the country. To obtain the necessary INVIMA regulatory approval, the initial stage involves identifying the appropriate classification for your medical device. Colombia follows a risk-based classification system that is similar to the European scheme, comprising four classes: Class I, Class IIa, Class IIb, and Class III.

Foreign Testing Applicability

Foreign testing data may be applicable for registration in Colombia, provided it complies with Colombian regulations and is relevant to the device's safety and performance. To market your medical device in Colombia, it is essential to obtain a Certificate of Free Sale (CFS) or a Certificate to Foreign Government (CFG) from your home country or from a market recognized by INVIMA.

Impact of EU/US Approvals on Registration

Having approvals from the European Union (EU) or the United States (US) can greatly simplify the registration process for medical devices in Colombia. These approvals act as evidence that your device meets rigorous regulatory standards, making the registration process smoother and faster.

Import and Distribution Requirements

Medical device importers and distributors in Colombia are required to secure a valid operating license from INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). This license is essential to ensure compliance with regulatory regulations and allows businesses to legally import and distribute medical devices in the country.

List of Documents Required

The specific list of documents varies depending on the medical device's classification and intended use. It generally includes:

1. Technical Documentation (Design, Manufacturing, Performance, etc.).

2. Clinical Evaluation Report (if applicable).

3. Labelling and IFU (Instructions for Use).

4. Testing Reports.

5. GMP Certificate (if applicable).

GMP Inspection Requirements

INVIMA, the regulatory authority in Colombia, plays a vital role in ensuring the safety and quality of medical products in the country. They enforce compliance with good manufacturing practices (GMP) for medicine producers, technical sanitary conditions for medical device producers, and conditioning and storage conditions for importers of medical devices.

Timeline and Associated Fees

INVIMA has implemented an immediate acceptance process for Class I and IIa device submissions. Manufacturers can begin importing right away upon receipt of the certificate, although the full technical file still needs to be reviewed by INVIMA. This new process helps address the long review times and backlog experienced within the Ministry of Health. However, Class IIb and III devices must undergo the formal review and approval process, which typically takes 6-8 months before they can be sold.

When it comes to registration fees for medical devices in Colombia, the costs are as follows:

1. For class I and IIa medical devices, the fee stands at USD 725.

2. Class IIb and III medical devices have a slightly higher fee of USD 820.

Post-Market Surveillance

Colombia prioritizes post-market surveillance to ensure the safety and quality of medical devices. Manufacturers and authorized representatives must report adverse events and technical complaints to INVIMA, enabling them to monitor device performance and take necessary actions for safety concerns. Furthermore, INVIMA conducts regular inspections and audits to ensure compliance with regulations, including post-market surveillance requirements, thereby identifying and addressing any non-compliance issues and maintaining the required standards for medical devices.

Post Marketing Activities

a) Pharmacovigilance: It is mandatory for companies to have a pharmacovigilance system in place to monitor and report any adverse events related to their medical devices.

b) Variations: Any changes made to the medical device require submission of variation applications to INVIMA for approval.

c) Renewal: Medical device registrations need to be renewed periodically as per the specified guidelines of INVIMA.

d) Audits: Regulatory authorities have the authority to conduct audits to ensure that companies are in compliance with all relevant regulations.

Conclusion:

Colombia has garnered well-deserved admiration for its unwavering commitment to ensuring the health and well-being of its citizens. This commitment is exemplified through the remarkable strides taken in implementing resolute regulations for medical devices.

References:

Colombian National Food and Drug Surveillance Institute (INVIMA) - http://www.invima.gov.co/

Regulations for Medical Devices in Colombia - Resolución 2003/2014 (currently being updated)

International Medical Device Regulators Forum (IMDRF) - https://imdrf.org/

ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes