Why is INVIMA prohibiting the grouping of Category III Reagents? Discover how to avoid customs blocks
The Specialized Chamber for Medical Devices is rejecting grouped registrations. Understand the new regulations and how to secure the import of your IVDRs.
If your company imports or commercializes high-risk In Vitro Diagnostic Reagents (IVDR) in Colombia, your current sanitary registrations are likely at risk.
Historically, many companies managed to optimize their budgets by grouping multiple references or Category III "kits" under the same file with INVIMA. However, the Specialized Chamber has taken a definitive turn on this practice, and ignorance of the new rule is already costing millions in port retentions.
The End of Massive Groupings
The Specialized Chamber for Medical Devices and In Vitro Diagnostic Reagents has been clear: grouping under a single sanitary registration applies uniquely and exclusively to risks I and II.
Since Category III reagents are intended for the diagnosis of serious communicable diseases and screening in blood banks, INVIMA now demands individual clinical and analytical traceability. If you have a grouped registration that is about to expire, be prepared: the renewal will be rejected. You must break down your portfolio and process individual registrations before your current coverage expires.
Is there a fast track for registration?
Fortunately, yes. While INVIMA closes the door to groupings, it keeps a homologation "fast track" open. If your reagent is manufactured and freely commercialized in the United States, the European Economic Community, Canada, Japan, or Australia, you can exempt yourself from the prior evaluation of the Specialized Chamber by providing the Certificate of Free Sale (CFS) from said country.
This is the most aggressive and efficient time-to-market strategy you can use today.
What about Research Use Only (RUO) supplies?
Do not assume that because they are "research use only" (RUO) they are exempt from controls. To import these types of analytes, it is now imperative to process the Certificate of Non-Obligatoriness through the VUCE, or your goods will be confiscated on suspicion of registration evasion.
Sources and Legal Disclaimer: This document has been drafted by Vexpro Consultores for informational purposes. Based on Acts 7 of 2024, 4 of 2025, 21 of 2021, and 7 of 2023 of the SEDMRI (INVIMA). It does not replace the official concept of the health authority.
Downloadable Resource
Thematic Guide 1: Specialized Regulation of In Vitro Diagnostics