Prions and Traceability: Are you sure your biomaterial will pass INVIMA's scrutiny?
Commercializing biological origin products in Colombia represents high scrutiny. Understand INVIMA's entry barriers for allografts and xenografts.
Commercializing cardiovascular patches, dermal matrices, tissue fillers, or biological sutures in Colombia represents the highest level of scrutiny by the health authority. Being biological origin products, the line between saving a life or causing an epidemiological emergency is very thin.
Recent INVIMA acts have tightened the entry barriers for these products, radically differentiating the rules between those derived from humans and those of animal origin.
Human Allografts (HCT/Ps): Not Medical Devices
If you are trying to register a human soft tissue allograft under the route of Decree 4725 of 2005, you are wasting your time and money. The Specialized Chamber has strictly categorized these products as anatomical components, regulated under the Organ Donation Law.
For those human origin products that historically managed to obtain a sanitary registration, INVIMA has initiated ruthless ex officio reviews. They demand uninterrupted documentary traceability from the original exclusion of the donor to implantation in the patient. If your headquarters cannot provide you with the complete "biological history" of the batches to rule out HIV, Hepatitis, and other infections, your registration will be immediately canceled.
Xenografts: The threat of prion diseases
For technologies manufactured with bovine collagen, porcine pericardium, or similar, INVIMA does not forgive certification errors.
A rookie (and very costly) mistake is presenting to INVIMA a certificate from the slaughterhouse or the international agricultural authority stating that the meat is "fit for human consumption." INVIMA will reject that document. Biosafety for an implantable device is infinitely superior to food safety.
It is mandatory to provide an official certificate from the authority of the country of origin explicitly stating that the animal was free of prion diseases (Transmissible Spongiform Encephalopathies), in addition to demonstrating with raw studies all decellularization processes to mitigate immunological rejections.
Sources and Legal Disclaimer: This document has been drafted by Vexpro Consultores for informational purposes. Based on Acts 6 of 2022, 7 of 2020, and 8 of 2023 of the SEDMRI (INVIMA). It does not replace the official concept of the health authority.
Downloadable Resource
Thematic Guide 3: Biosafety and Devices of Biological Origin