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.
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