The Ministry of Health and Social Protection has released a draft decree for public comment that would establish new regulations for the authorization, monitoring, and control of medical devices in Colombia. The proposed rules are intended to ensure the quality, safety, and effectiveness of medical devices used in the country.
According to the ministry, the decree aims to regulate the sanitary regime applicable to the authorization for commercialization of medical devices for human use in Colombia. This includes requirements for notification, sanitary registration, and permits for commercialization. It also sets out provisions related to sanitary surveillance throughout the entire life cycle of these products.
The regulations would apply to all individuals and legal entities involved in manufacturing, processing, packaging, storage, sale, use, importation, exportation, commercialization, and maintenance of medical devices within Colombia.
Manufacturers will be required to design and produce devices that are safe and function as intended during their entire lifecycle. The design and manufacturing activities must be conducted under a quality management system controlled by the manufacturer. Compliance with all essential principles must be demonstrated and evaluated according to what is defined in this administrative act.
Additionally, every manufacturer or importer of medical devices must have a professional responsible for ensuring compliance with regulations and product quality. This individual must have experience in the field of medical devices.
Stakeholders are invited to submit comments on the draft decree by January 28, 2026.
