INVIMA Colombia Classification & Device Grouping

Colombia Medical Device Classification Scheme

The classification of medical devices in Colombia is established in Decree 4725/2005, though it closely follows the EU MDD 93/42/EEC classification.

• Class I: Low-risk devices, such as non-invasive medical devices and those with minimal potential for harm when used as intended.
• Class IIa: Medium-risk devices that have a moderate potential to cause harm under the applicable Colombian rules; EU Notified Body conformity assessment is not a Colombian classification requirement.
• Class IIb: Encompasses higher-risk devices than Class IIa, requiring a more rigorous assessment and often including active medical devices and those used for critical treatments.
• Class III: Represents the highest-risk category, including devices such as implantable devices and life-sustaining equipment, requiring the most stringent regulatory oversight and assessment.

Ordinary Class I/IIa devices generally use automatic sanitary registration, while ordinary IIb/III devices undergo the applicable evaluation. Controlled-technology biomedical equipment is a separate category and must not be equated with all higher-risk devices. Low-risk devices are allowed the "automatic registration" pathway, that is, automatic authorization for registration after submitting the required documents. High-risk devices need to be approved by INVIMA before they go on the market.

IVD Classification in Colombia

Decree 3770/2004 established the classification scheme for IVDs. IVD products are classified into Class I (low risk), Class II (medium risk), and Class III (high risk). Class I and Class II can be registered through the "automatic registration" route, that is, automatic authorization registration after submitting the required documents. Class III needs to obtain pre-market approval and may require additional approval from the IVD professional committee.

Medical device grouping in Colombia

Grouping allows you to register multiple products under the same registration, such as medical device kits, component parts, companion software, etc. The following characteristics must be met to group products in Colombia under one registration:

• Same risk class
• Same indications for use
• Same manufacturer

Assess IVD grouping under the separate current IVD rules and procedure, including manufacturer, category, test area and any numerical or product-specific limits. Do not infer eligibility from the medical-device grouping rationale.

Classification evidence for the Colombian file

Record the local rule rather than copying the EU class. Connect the result to INVIMA registration, labeling and postmarket responsibilities.