Orthopedics Alert: The new Osteosynthesis restructuring that will cancel your sanitary registration

The orthopedic implant and osteosynthesis material market in Colombia has just suffered a regulatory earthquake. If your company imports bone fixation systems, you must act against the clock to avoid the freezing of your inventories.

INVIMA, through its Specialized Chamber, has issued a massive call for ex officio review with an ultimatum: generic groupings for osteosynthesis are over.

What is INVIMA demanding?

From a biomechanical and public health point of view, the authority has concluded that it is not viable to cover screws or plates designed for radically different anatomical loads under the same sanitary registration.

If your sanitary registration groups material for different areas of the body, it will lose its executive force in the next 6 months. The new rule requires strict anatomical segmentation. You must divide your portfolio and process modifications to group the components exclusively in one of these 6 categories: Skull, Maxillofacial, Limbs, Spine, Thorax, or Pelvis.

Beware of External Fixation

The change is even more drastic for external fixation systems. Because some components pierce the skin and others remain outside, the risk of infection is asymmetrical. Therefore, INVIMA requires you to classify the risk level by individual pieces:

• Nails and Schanz screws: Risk IIB
• Bars, washers, and ball joints: Risk IIA

Assigning a generic "low risk" to the entire orthopedic kit is grounds for immediate rejection.

The Implant Card: A non-negotiable document

Added to this, remember that the filing of any implantable device compulsorily requires the design of the Implant Card. This document must guarantee traceability between the batch, the IPS, and the patient. Without this design in the file, your process will not even be evaluated.

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Sources and Legal Disclaimer: This document has been drafted by Vexpro Consultores for informational purposes. Based on the Acts of 2025 (numerals 3.10 and 3.11), Act 11 of 2019, and Act 12 of 2025 of the SEDMRI (INVIMA). It does not replace the official concept of the health authority.