Medical Devices (All Classifications)

Importation

Manufacturers must import their device 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 a device is expected to be exempt from registration, it is recommended that the manufacturer seek a Certificate of Non-Intervention (Certificacion de no obligatoriedad de registro sanitario) from INVIMA stating that the device is exempt. 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

Medical device registrations with INVIMA are valid for 10 years. Renewals must be initiated at least 3 months prior to the registration expiration, according to Articles 31 and 32 of Decree 4725/2005. It is recommended to begin the renewal 9 months prior to expiration. The renewal procedure follows the same procedure as the initial registration, though an updated dossier must be prepared. Class I and lla devices eligible for automatic registration are also eligible for automatic renewal, so Class I and lla renewals can be obtained within 2-4 days of complete submission. Higher-risk device renewals are subject to the official review period of 90 business days.

Modifications/Product Changes

Change notification requirements are addressed in Article 30 of Decree 4725/2005 (as modified by Decree 582/17). Changes that require an application for the modification of the health license include:

• Change of owner of the health license.

• Change of name of the owner of the health license.

• Change of domicile of the owner of the health license.

• Change of manufacturer of the health license.

• Change of name of the manufacturer of the health license.

• Change of domicile of the manufacturer of the health license.

• Addition of manufacturer of the health license.

• Addition of importer of the health license.

• Change of name of the importer of the health license.

• Change of domicile of the importer of the health license.

• Addition of importer of the product of the health license.

• Addition of conditioner of the health license.

• Change of name of the conditioner of the health license.

• Change of domicile of the conditioner of the heath license.

• Change of name of the product.

• Change of systems and subsystems of the product.

• Change of composition of the product.

• Change of commercial presentations.

• Change of primary packaging materials.

• Change of useful life of the product.

• Change of labels.

• Addition of references to the product.

• Addition of warnings.

• Change of classification of the product.

• Addition or exclusion of a trademark.

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.

Once INVIMA grants the modification, they will review the application and may request additional information, granting the applicant a term of 90 working days to answer the request.

Significant changes that may affect the safety and effectiveness, design changes, changes in the chemical composition of the material, changes in the energy source, or changes in the manufacturing processes require a new registration.

Inspections

Per Article 66 of Decree 4725/2005, INVIMA has the authority to inspect manufacturers and importers for compliance with medical device regulations. Article 66 indicates that establishments marketing Class lib and III devices should be visited by INVIMA at least once a year (applicable to local importers and distributors).

Post-Market Surveillance (PMS)/Vigilance

PMS

Post-market control and vigilance are addressed in Chapter IX of Decree 4725/2005 and Ministry Resolution 004816/2008. Post-market surveillance requirements are generally similar to EU requirements. In addition to surveillance and vigilance, according to Article 38 of Decree 4725/2005, manufacturers and importers of biomedical equipment (i.e., Controlled devices) are required to provide after-market services and spare parts, or contract to a third-party to provide these services. The timeframe for these services is not specified, but it is assumed to be the shelf-life of the product.

Vigilance

Adverse Events/lncidents

Manufacturers and importers are dually responsible for vigilance activities. Manufacturers and importers are required to submit a summary periodic report on a quarterly basis, even if no adverse events occurred. Manufacturers and importers are required to report serious adverse events and incidents to INVIMA within 72 hours. INVIMA defines 4 categories of adverse events and incidents:

• Serious adverse event: An unintentional event that could have led to death or serious deterioration in the health of the user.

• Non-serious adverse event: An unintentional event that could not have led to death or serious deterioration in the health of the user.

• Serious adverse incident: potential risk of harm that could have led to death or serious deterioration in the health of the user, but an adverse outcome was avoided due to intervention or chance.

• Non-serious adverse incident: potential risk of harm that could have led to damage different from death or serious deterioration in the health of the user, but an adverse outcome was avoided due to intervention or chance.

Non-serious adverse events must be submitted to INVIMA in the quarterly Periodic Report. The Periodic Report should include the product and patient information specified in Article 17 of Resolution 004816/2008.

Additionally, international warnings or warnings by the health authority of the country of origin regarding the device must be reported to INVIMA.

Recalls/Field Safety Corrective Actions (FSCA)

Per Article 9 of Resolution 004816/2008, manufacturers and importers are obligated to take appropriate corrective actions once aware of an adverse event or incident. Corrective actions taken in response to adverse events and incidents should be detailed in the Periodic Reports provided to INVIMA.

The procedure for carrying out a recall is specified in Article 19 of Resolution 004816/2008. Manufacturers and importers must notify INVIMA of the total or partial withdrawal of devices from the market when the devices pose a risk to patient health.

The notification of recall must include the following information:

• Name, references, batch numbers or series of the medical device, object of withdrawal, and expiration date (where applicable).

• Causes that led to the withdrawal of products with supporting documentation.

• Recipients of the medical devices in Colombia.

• Actions that have been taken to carry out the withdrawal of the product from the market, including estimated times of withdrawal and final disposition.