Medical Device Registration in Colombia
Regulatory body: 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 have an office in Colombia or appoint a local company to submit the registration. Such a company must possess a Certification of Storing and Conditioning Capacity issued by INVIMA. A Certificate of GMP from the country of origin must also be included with the technical documentation submitted.
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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