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Colombia

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Colombia
Medical Device Product Registration and Approval

MEDICAL DEVICE REGISTRATION AND APPROVAL IN COLOMBIA

 

Medical device classification in Colombia follows the four-tiered risk model, much like the one used in Europe (Class I, Class lla, Class llb and Class lll). Interventional Concepts must verify the classification of the medical device before registration.

To register, the following will guide you on the required procedures:

 

  • Assign a home country representative under the absence of a local presence in Columbia;

  • Get an in-country Certification of Free Sale (CFS) or Certificate to Foreign Government or any INVIMA approved market;

  • Present quality system certificate (i.e. ISO 13485);

  • Present information and commercial history of the product - Test reports on Classes lla, llb and lll devices are necessary and clinical data is required for Classes llb and lll devices;

  • The legal representative will submit the application in Spanish to INVIMA and will pay the required fee. The approval process could take up to 3-4 months; and

  • A registration certificate will be issued upon approval, and will be valid for 10 years.

Example Of Approval

Source: INVIMA

Medical device regulatory guidelines
License Holding

LATIN AMERICA REP

Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.

If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.

 

Some of the responsibilities include:

  • Acting as a first point of contact with Regulatory authorities and import/customs offices

  • Being responsible for pre-certification and post-approval inquiries

  • Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor

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Extra RA/QA Support

MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION

ARQon provide onsite/offsite monthly regulatory support for regional registration in Columbia.

Contact Us for more details.

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Drug Services

THERAPEUTIC AND COSMETIC APPROVAL

ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Columbia.

Read more

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Health Safety

WIRELESS, RADIATION AND PACKAGING APPROVAL

ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Columbia.

Contact Us for more details.

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product registration
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