INVIMA Colombia Medical Device Classification and Grouping
The classification of medical devices in Colombia follows the EU MDD 93/42/EEC classification.
Colombia Medical Device Classification Scheme
The classification of medical devices in Colombia 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 and require conformity assessment by a Notified Body.
- 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.
Devices are then divided into "controlled" and "uncontrolled" categories based on their classification. Class I and IIa devices usually belong to the uncontrolled category, while devices with higher risk levels belong to the controlled category. 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 before they go on the market.
IVD Classification in Colombia
In Vitro Diagnostic 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
Class I and II IVDs can be grouped with up to 15 reagents included in a single registration. Grouped IVDs must have the same risk classification, belong to the same area, and have the same manufacturer. Grouping criteria are not specified for Class III IVDs because they cannot be grouped.
Frequently
Asked Questions
How does classification affect quality management system requirements for medical devices in Colombia?
Manufacturers are required to implement and maintain a quality management system (QMS) compliant with international standards such as ISO 13485 to ensure the safety and effectiveness of their medical devices. However, an ISO 13485 certificate is not required for Class I or IIa devices, though we recommend including one in your documentation. For Class IIb and III devices, INVIMA requires proof of a QMS, such as an ISO 13485 certificate.
How does classification affect our device’s time to market in Colombia?
For Class I and IIa devices and Class I and II IVDs, “automatic” approval can take 15 working days. For Class IIb and III devices, approval can take 6-8 months, even though official timelines from INVIMA state 15 working days. For Class III IVDs, the official timeline is 90 working days, but in reality can take 6-8 months.
How does classification affect the validity time of my INVIMA approval?
Medical device registrations are valid for 10 years. Class I and II IVDs are valid for ten years, while Class III IVD registrations are valid for 5 years.
