Colombia medical device regulations
Official sources linkedINVIMA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
15 documents4 categories100% linked to official sourcesauthority INVIMA15 readable HTML
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Resolución 1405/2022 | 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. | UDI | February 8, 2024 | Official |
| Decreto 334/2022 | 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. | Registration | January 2024 | Official |
| Resolución 214/2022 | Custom Oral Medical Devices and Dental Laboratories Sanitary requirements for custom-made oral medical devices and the establishments that manufacture, repair, dispense, or adapt them. Adopts verification guides. | GMP/QMS | February 15, 2022 | Official |
| Decreto 1036/2018 | Orphan, Research and Laboratory IVD Reagents Import and commercialization rules for orphan IVDs, research-use reagents, analyte-specific reagents, and general laboratory in vitro reagents not fully covered by Decreto 3770/2004. | Registration | June 21, 2018 | Official |
| Resolución 5491/2017 | Custom Hearing-Aid Medical Devices Requirements for custom-made hearing-aid devices and the establishments that manufacture, assemble, repair, dispense, or adapt them. | GMP/QMS | January 17, 2018 | Official |
| Decreto 581/2017 | Amendments to IVD Registration and Renewal Modifies Decreto 3770/2004. Updates automatic sanitary-registration and renewal rules for Category I and II in vitro diagnostic reagents. | Registration | April 4, 2017 | Official |
| Decreto 582/2017 | Simplified Registration Renewal for Medical Devices Allows automatic renewal of Marketing Authorization if labeling and manufacturing processes have not been amended. Simplifies registration procedures. | Registration | April 4, 2017 | Official |
| Resolución 2968/2015 | Custom External Orthopedic Medical Devices Sanitary requirements for establishments that make and adapt custom-made external orthopedic medical devices. | GMP/QMS | August 14, 2015 | Official |
| Decreto 3275/2009 | 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. | Registration | August 28, 2009 | Official |
| Resolución 4816/2008 | National Technovigilance Program Establishes Colombia's National Technovigilance Program for post-market surveillance. Defines adverse event reporting requirements, timelines, and responsibilities. | Vigilance | November 27, 2008 | Official |
| Resolución 4396/2008 | 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. | GMP/QMS | November 12, 2008 | Official |
| Resolución 4002/2007 | 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. | GMP/QMS | November 2, 2007 | Official |
| Decreto 1030/2007 | 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. | GMP/QMS | March 30, 2007 | Official |
| Decreto 4725/2005 | 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. | Registration | December 26, 2005 | Official |
| Decreto 3770/2004 | 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. | Registration | November 16, 2004 | Official |
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Tracked from official INVIMA publications · row IDs are stable — cite as regulations:colombia:decreto-1030-2007