Articles, guides, and analysis on INVIMA registrations, Colombian regulation, and regulatory trends for medical devices, cosmetics, and homecare products.
Starting July 2026, INVIMA's Virtual Office will issue filing numbers immediately upon payment, ending the prior-review bottleneck that added up to 15 business days to every application.
INVIMA's safety alerts portal listed several medical devices under follow-up on May 29, 2026. For registration holders, importers and distributors, these publications should trigger a documented review of traceability, technovigilance and post-market controls.
Discover the main causes why companies are losing their sanitary registrations through INVIMA's Ex Officio Reviews.
Commercializing biological origin products in Colombia represents high scrutiny. Understand INVIMA's entry barriers for allografts and xenografts.
INVIMA issues an official warning about the fraudulent marketing of 'GLP-1 PATCHES (LUMESSA)', a product with no sanitary registration that poses a serious public health risk.
The orthopedic implant market faces a regulatory earthquake. Discover how INVIMA's new requirement will affect your osteosynthesis registrations.
The Specialized Chamber for Medical Devices is rejecting grouped registrations. Understand the new regulations and how to secure the import of your IVDRs.
Obtaining an INVIMA registration is only the first step. Decree 4725 and Resolution 4816 impose permanent technovigilance obligations that many companies overlook — and non-compliance can put the registration at risk.
Devices with AI components or clinical decision-making software raise questions that current Colombian regulation does not explicitly resolve. Here's what you need to know if your portfolio includes Software as a Medical Device (SaMD) or AI-enabled devices.
The Andean Community is advancing adjustments to Decision 516, which governs cosmetic NSOs. Learn what is changing, what deadlines matter, and what to review in your portfolio before the next update takes effect.
Guides, templates, and regulatory documents to support your process.
