🇨🇴Colombia Medical Device Regulations

UDI and Semantic Reporting Requirements for Medical Devices

Establishes semantic standard and UDI-DI coding requirements for medical devices. Recognizes codes from GS1, HIBCC, ICCBBA, IFA. Transition periods by risk class until 2026.

Health Registration Renewal and Advertising Requirements

Provisions for renewal, modification, and suspension of health registrations. All advertising must be consistent with conditions approved in health registration.

Simplified Registration Renewal for Medical Devices

Allows automatic renewal of Marketing Authorization if labeling and manufacturing processes have not been amended. Simplifies registration procedures.

Modification to Medical Device Registration Requirements

Modifies Article 1 and adds a paragraph to Article 18 in Decreto 4725/2005, updating requirements for medical device registration and biomedical equipment spare parts.

National Technovigilance Program

Establishes Colombia's National Technovigilance Program for post-market surveillance. Defines adverse event reporting requirements, timelines, and responsibilities.

Technical Sanitary Conditions for Medical Device Manufacturing

Adopts the manual of technical sanitary conditions for establishments that manufacture custom-made medical devices for visual and ocular health.

Storage and Conditioning Requirements for Medical Devices

Adopts the Manual of Storage and Conditioning Capacity Requirements for Medical Devices. Establishes conditions for proper storage facilities.

Technical Requirements for Custom Medical Devices

Technical sanitary requirements for custom-made medical devices for visual and ocular health, and establishments that manufacture and commercialize them.

Medical Device Registration and Surveillance Regime

Core regulation for medical device sanitary registration, commercialization permits, and surveillance in Colombia. Defines risk classification (Class I, IIa, IIb, III) and registration pathways.

In Vitro Diagnostic Medical Devices Registration

Regulatory framework for in vitro diagnostic (IVD) medical devices in Colombia. Establishes IVD classification into Categories I, II, and III based on risk.