Frequently Asked Questions

Yes. INVIMA requires clearly delimited areas for reception, storage, quarantine, returns, conditioning, and dispatch. These zones must be physically separated and meet hygiene, order, and environmental control conditions.

No. Facilities cannot be located within residential homes or makeshift spaces. They must be exclusive areas for storage and management of medical devices.

You must control temperature, humidity, lighting, and ventilation according to the product manufacturer's requirements. Additionally, you must monitor and record these values periodically.

It must be a professional in a field related to medical devices, with demonstrable experience. They are responsible for approving inspections, conditioning, rejections, returns, authorizations, and decisions regarding product quality.

Yes. There must be an updated organizational chart showing the hierarchical structure, including outsourced personnel.

Yes. INVIMA requires manuals and procedures that are coded, current, and formally approved by the Technical Director. These include reception, inspection, storage, conditioning, returns, rejections, transport, and technovigilance.

It must be received in a designated area, visually inspected, verified against documentation, and classified into a quality status: approved, quarantined, or rejected.

It is the classification that determines if the product is fit for commercialization (approved), requires additional verification (quarantine), or must be withdrawn/prohibited (rejected).

Yes, but only through authorized and controlled conditioning. You must have a procedure approved by the Technical Director, line clearance, label control, and process records. You cannot recondition a product with erroneous or altered original labeling.

It must include: Line clearance, Label verification, Quantity control, Process recording, and Final release by the Technical Director.

They must be classified as rejected and placed in a specific area. Their final disposal must be documented and include approval from the Technical Director and evidence of the disposal method.

You must have a procedure to evaluate the cause, classify the device status, record the return, and define its final destination.

You must ensure that transport does not affect the quality of the device. The vehicle must be verified, conditions recorded, and product parameters guaranteed during transport.

Because INVIMA is the authority in charge of regulating, authorizing, and monitoring all medical devices and biomedical equipment entering the country. Decree 4725 of 2005 establishes that all imports require sanitary registration, marketing permission, or sanitary certification to ensure product safety.

It depends on the product, but generally an importer needs:
• Marketing Permission or Sanitary Registration for the product (depending on risk classification).
• Certification in Storage and/or Conditioning Capacity (CCAA) when acting as an importer.
Decree 4725 defines registration procedures, and Resolution 4002 defines CCAA certification.

• Sanitary Registration: authorizes the importation and commercialization of the medical device. Requires technical, legal, and safety documentation of the product.
• CCAA: certifies that the importer has adequate infrastructure, processes, and personnel to store and condition the products.

It is any instrument, biomedical equipment, machine, software, material, or object intended by the manufacturer for human use without primary pharmacological or immunological action.

It is the system that allows identifying, analyzing, and reporting incidents or adverse events associated with medical devices. You must have: A technovigilance manual, a responsible professional registered in the INVIMA network, event recording and reporting, and root cause analysis methodology.

You must have a mandatory technovigilance program, which includes: Event recording, Analysis, and Notifications to INVIMA.

If they are serious, they can suspend the CCAA certification until the findings are corrected. If the importer does not renew or does not present complete documentation, they lose validity and will not be able to import.

INVIMA can apply measures such as: Suspension of activities, Sanitary seals, Merchandise retention, and Administrative and legal sanctions.