Medical Device Registration in Colombia
Regulatory authority: The National Institute for Surveillance of Medicines and Food (INVIMA) is the competent authority for medical and in-vitro diagnostic devices in Colombia. Prior to manufacturing, selling, importing, exporting, packaging, processing, and/or storing a medical device in Colombia, a company must obtain a Sanitary Register that is issued by INVIMA. According to the activities to be developed, different modalities of registration exist.
Classification: medical devices are divided into four classes (I, IIa, IIb and III) depending on the risk level.
To register a medical or IVD device with the Colombian Authority, the manufacturer must appoint a local company importer to be included in the submission for the registration. Such a company must possess a Certification of Storing and Conditioning Capacity issued by INVIMA. Most products in classes I and IIa can go through an “automatic” registration, which means that shortly (72 hours) after submission INVIMA issues the register, without waiting to complete the technical evaluation.
Timeframe of registration: Medical devices are registered in Colombia within a timeframe of 72 hours for “automatic” registration, and 4-6 months for “regular” registration.
Length of license: Licenses issued in Colombia expire after ten years.
As of 2012, Arazy Group now offers our new service, Licensale.com. This unique, cloud-based application provides you, the medical or IVD device manufacturer, with a comprehensive service that results in the successful registration of your product in Colombia and ownership of the registration license through your company.
Once you register in Colombia through Licensale.com, a global compliance profile is generated that easily facilitates the registration of your product in more than 80 countries around the world. Licensale.com creates a foundation that makes registration simpler, faster, and more cost-effective than any alternative available today.
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