Regulatory Challenges for Medical Devices in Colombia: Semantic Standard

Thursday 24 April 2025

Regulation of medical devices is an essential mechanism for ensuring patient access to safe, effective and high quality devices, while restricting those products that do not meet these standards. Properly implemented, the regulation ensures significant public benefits, protecting the health and safety of patients, medical personnel and the community.

Although some countries have robust regulatory systems thanks to their experience, they must be constantly updated to meet the challenges posed by dynamic markets, rapid technological evolution and increased population demand. Recognizing the problems inherent in regulation is key to developing innovative regulatory approaches.

In 2007, during the 60th World Health Assembly, Resolution WHA60.29 was adopted, which suggests that Member States develop national or regional guidelines on good manufacturing and regulatory practices, establish surveillance systems and take measures to ensure the quality, safety and efficacy of medical devices. It also encourages participation in international harmonization.

In Colombia, as part of an effort to achieve regulatory harmonization, the semantic standard has been implemented as a tool to standardize the naming of medical devices and in vitro diagnostic reagents, allowing their identification and classification according to international standards. In addition, it facilitates the traceability of devices at each stage of the logistics chain, from manufacturing to distribution, improving their handling, supply and procurement in healthcare services. This also helps to optimize the management of spending within the General Social Security Health System, regulate prices and consumption, as well as facilitate the exchange of information between the competent authorities in inspection, surveillance and control.

The reform of the regulatory system requires a cultural change that includes the education and training of key players such as licensees, manufacturers, importers and health service providers. This process presents important challenges for the health system. Currently, approximately 742,920 medical devices and 77,601 in vitro diagnostic reagents in Colombia have a sanitary registration approved by Invima. Consolidating clear, complete and accurate information is a challenge that requires a universal language that takes into account international developments, constant communication, training, inter-institutional coordination and a period of adoption of the standard that includes a pilot to identify lessons learned both locally and abroad.

The progress achieved through these initiatives should enable a successful transition to the regulatory pathway, with the ultimate goal of promoting public health and improving patient safety and well-being.

Our Contribution: From ANNAR Health Technologies we contribute to the strengthening of the health system in Colombia by providing diagnostic solutions of the highest quality. Currently, we have more than 1013 health registries in force, which positions us as a key player in the implementation of the semantic standard. Our commitment includes ongoing training of our team, ensuring that our knowledge positively impacts patient safety and well-being. In addition, we actively participate in inter-institutional cooperation with regulatory authorities and other actors in the system to ensure the effective adoption of the Semantic Standard, collaborating in the generation of innovative solutions that optimize the management of resources to improve the traceability of medical devices.

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