In Vitro Diagnostic Devices (IVD) (All Classifications)

Importation

Manufacturers must import their IVD within the first 3 years of approval, or INVIMA can cancel the registration. Only licensed importers can import medical devices into Colombia. Importers must be identified in the device registration.

If an IVD reagent is expected to be exempt from registration, it is recommended that the manufacturer seek a Certification of Non-Intervention (Certificación de no obligatoriedad de registro sanitario) for analytical reagents/ROlJ reagents from INVIMA. This will avoid problems with Customs who may otherwise hold the product for verification. The request for a Certificate of Non-Intervention from INVIMA should be submitted by a representative in Colombia. A product brochure and instructions for use should be submitted with the request. A fee is charged by INVIMA for the Certificate. INVIMA should take between 20—30 days to provide a Certificate of Non-intervention.

Post Approval

Renewals

Category I and Il IVD device registrations are valid for ten (10) years. Category Ill IVD device registrations are valid for five (5) years. Renewal applications should be initiated six (6) months prior to registration expiration, according to Article 21 of Decree 3770/2004.

Modifications/Product Changes

Product modifications for IVD reagents are addressed in Article 19 of Decree 3770/2004, amended by Articles 5-8 of Decree 581/2017. Changes to basic composition, reformulations, or major changes to the initial approval characteristics require a new registration.

Minor modifications are categorized as either technical or legal modifications. The modification type determines the documents to be provided (such as Power of Attorney, technical documentation, and/or certificates). INVIMA will issue a resolution after the application has been submitted and the applicable fee(s) has been paid. INVIMA has 2-4 days to respond, as modifications are granted automatically upon submission of a complete application. Once authorization for the change has been granted, the changed device can enter the Colombian market. As a final step, INVIMA will review the modification application and may request additional information, granting the applicant a term of 30 working days to respond to the request.

Inspections

Per Articles 35-36 of Decree 3770/2004, INVIMA has the authority to inspect manufacturers and importers for compliance with IVD regulations and may conduct an inspection of the local establishment's facilities once every 2 years, or whenever INVIMA deems appropriate.

Post-Market Surveillance (PMS)/Vigilance

PMS

INVIMA has established the Programa Nacional de Reactivovigilancia (National Reagent Surveillance Program) in Resolution No. 2013038979 of 2013, based on the provisions of Article 34 of Decree 3770/2004, for monitoring the post-market safety of IVDs. Responsibilities for post-market surveillance are shared among the in-country representative, importer, and manufacturer.

Vigilance

Adverse Events/lncidents

In Article 6 of Resolution No. 2013038979 of 2013, INVIMA provides the following definitions for "adverse event" and "incident" (unofficial translations):

Adverse Event: Unintentional damage to the user, patient, or the environment that occurs as a result of the use of an in vitro diagnostic reagent.

Incident: Potential unintended damage to the user, patient, or the environment that could occur as a result of the use of an in vitro diagnostic reagent. Likewise, any circumstance that occurs in clinical care that although it does not generate harm, in its occurrence incorporates failures in the care processes.

Article 16 indicates that an adverse event should be reported immediately and never exceeding five days from the knowledge of the event. Establishments should report adverse events associated with IVD reagents using the INVIMA Reporting Form.

Additionally, international warnings or warnings issued by the health authority of the country of origin regarding the IVD reagent must be reported to INVIMA within five days.

Establishments are required to submit a quarterly report to INVIMA summarizing any adverse events or incidents that occurred during this period, along with a summary of any corrective actions taken to address these unwanted effects.

Recalls/Field Safety Corrective Actions (FSCA)

The procedure for carrying out a recall is specified in Article 18 of Resolution No. 2013038979 of 2013. Manufacturers and importers must notify INVIMA of the total or partial withdrawal of IVD reagents from the market when the IVD reagents pose a risk to patient health. INVIMA must be notified of the recall within 72 hours of its commencement.

The notification of recall must include the information specified in Article 18, including the reason for withdrawal, quantities imported into Colombia, recipients of the IVD reagent, corrective and preventative actions taken to manage the risk, among other information.