Obtention of a license to commercialize a Medical Device or an In Vitro Device (MD or an IVD) in Colombia includes the provision of legal and technical documentation to the National Institute for Surveillance of medicines and Food Stuff (INVIMA) as requested by Decree 4725/2005 regarding MDs and Decree 3770/2006 regarding IVDs. Within the documentation, an importer must be appointed. This importer should be capable of importing the product. This capability is demonstrated by means of a Certificate of Capacity of Storing and Conditioning (CCAA) which will ensure that it has spaces that meet the necessary conditions of hygiene, health, signage, etc., which must be safeguarded by extensive quality control and it is constantly updated to comply with the current health and quality management measures.
CCAA is a certificate issued by the National Institute for Surveillance of medicines and Food Stuff (INVIMA) after it has visited the premises and reviewed the protocols included by legislation[1] for MDs and IVDs to obtain this type of certificate.
Certificate of Storage and/or Conditioning Capacity (CCAA) has a validity of five years as from the date INVIMA issues a positive Resolution of the visit made to audit if the importer complies or not with legislation.
After these 5 years, importer must go through the same process to renew its CCAA which is granted only to the premise requested by the importer. If it has more than one premise, the importer should request visit and certification for each one.
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