temporary Importer of Record (IOR) Service for Foreign Medical Companies in colombia

Quickly add an importer of record (IOR) with a CCAA certificate to your INVIMA submission and start marketing your medical product in Colombia now

bioaccess™ IOR service allows foreign drug, medical device, and IVD manufacturers to expand into Colombia with ease. Our IOR service simplifies the market clearance of your medical product at INVIMA, and it saves you from the costs of establishing a legal entity or from waiting to find a suitable distributor with a CCAA certificate before obtaining your INVIMA certificate.


Quickly get your INVIMA market clearance registration certificate before you find a permanent IOR and distributor in Colombia.

It is essential that you have a fiscal presence in a new country in order to import goods. Before you submit your dossier to INVIMA to obtain regulatory market clearance for your medical product, you must name a legal entity in Colombia with a valid INVIMA-issued Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA) as your importer of record (IOR).

In compliance with Resolution 4002 of 2007, INVIMA issues a CCAA certificate to importers of medical products to ensure their technical capacity and quality. A CCAA ensures that a company in Colombia is in compliance with the sanitary conditions for storage and/or conditioning, quality control, staffing, and human resources to guarantee proper functioning.

The bioaccess™ temporary IOR service allows foreign manufacturers of medical products that do not have a local corporate presence or do not yet have an IOR with a valid CCAA, quickly obtain INVIMA market clearance and start marketing immediately in Colombia.

The importer of record (IOR) is officially noted by many governments as the owner or purchaser of the products being imported into a destination country. The IOR must ensure all goods are appropriately documented and valued. Furthermore, the IOR is the responsible party for the payment of duties, tariffs, and fees of the imported goods. The IOR should ensure compliance with all necessary regulations. Although the Colombian government prefers voluntary IOR compliance measures, an IOR may be subject to enforced compliance. Enforced compliance includes inspections and examinations of imports, audits of documentation, assessment of monetary penalties, investigations into IOR business dealings, civil penalties, and additional criminal penalties.

The IOR is the entity that has ownership of the imported goods at the time of import. The IOR entity becomes the temporary owner of the goods until the end buyer accepts the nationalized goods at its facility. As your IOR for a regulated product, we'll temporarily assume the liabilities associated with reporting adverse events, defending lawsuits, and other risks commonly associated with being responsible for reporting to INVIMA.

Our temporary IOR service in Colombia also includes the mandatory signature of our technical director in your INVIMA application form for the registration of your medical product.

Quickly expand your market and nationalize product samples with no commercial value into Colombia.

You will be able to list bioaccess™ as your importer/exporter for sanitary, customs, and taxation declaration purposes at the time of import/export. bioaccess™ will be responsible to customs, tax and regulatory authorities in Colombia. You will be able to quickly nationalize product samples with no commercial value into Colombia.


IOR service for nationalization. 100% done for you in Colombia.

Upon your request, bioaccess™ can apply for the necessary import/export licenses or permits, will maintain records, and will complete all regular filing requirements associated with the payment of duties and taxes. We can manage all the paperwork for international trade, compliance, and logistics requirements, including customs clearance.


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Pricing (USD)

INVIMA CCAA Certificate

$3,999 for one (1) year from the date of delivery of the CCAA and/or incorporation certificate to you. Payment in advance before delivery of the CCAA and/or the incorporation certificate.

Deliverables:

  1. An electronic copy of a valid CCAA certificate that the Client can attach to its biomedical product registration at INVIMA.

  2. An electronic copy of the incorporation certificate (aka Certificado de Existencia y Representación Legal)of the Service Provider's affiliated entity in Colombia that holds title to the CCAA.

  3. Signature of our technical director on the INVIMA application for a registration certificate.

IOR Service for Nationalization

15% of the CIF value of the goods.

Terms & Conditions

Read here.

General Terms & Conditions

  • Service applicable to foreign medical product manufacturers that a) do not yet have a permanent importer of record (IOR) and distributor in Colombia and need to quickly obtain an INVIMA registration certificate for their biomedical products and quickly name an IOR in their INVIMA registration certificate, and b) may need to nationalize product samples with no commercial value.

  • Pricing for the use of our CCAA certificate is valid for one (1) year from the date of delivery of our documents to you. If you still need our CCAA certificate after one year, bioaccess™ will charge $3,999 in advance for another one-year period.

  • Pricing applies to our CCAA added to one (1) registration certificate.

  • Pricing assumes that you a) need a CCAA from a local company in Colombia to obtain your INVIMA registration certificate, and/or b) to quickly nationalize product samples with no commercial value into Colombia, and c) that you will select a permanent IOR/distributor to commercialize your products in Colombia.

  • The pricing of our CCAA certificate service excludes (but is available at an additional charge from bioaccess™),

    • Use of our CCAA for a third party to process the nationalization of your biomedical product.

    • Processing of importation/nationalization and custom clearance.

    • Warehouse storage.

    • Fulfillment of domestic orders.

    • Application for import permits.

    • Technical support.

    • Technovigilance reporting.

    • Ordinary nationalization of biomedical products with commercial purposes in Colombia.

  • If after you obtain your INVIMA regulatory registration and market clearance certificate, you need to import your registered products into Colombia, you must find a permanent distributor to act as your IOR.

  • Read the full terms & conditions here.