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, which is issued by INVIMA.  According to the activities to be developed, different modalities of registration exist.

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 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.

Our country specific (*) regulatory services in Colombia include:

Medical Device specific regulation strategy reports, Medical Device Registration with INVIMA, Colombian Representative and certification holder for Medical Device manufacturers, INVIMA Technical documents Preparation, GMP audit compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Colombia!

(*) Colombian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.