Pharma and medical device regulation 2023

The National Food and Drug Surveillance Institute (INVIMA) is the competent authority for granting marketing authorisation for medical devices, medicinal products, cosmetics and dietary products, and for the surveillance of manufacturing facilities by issuing good laboratory practices and good manufacturing practice certi‘cation. INVIMA also has the administrative authority to investigate and punish violations of sanitary rules, examine over-the-counter drug advertising, and control prescription drug advertising.

Products monitored by INVIMA are classi‘ed according to the de‘nitions provided by regulatory law. For example, ’medical devicesq are de‘ned as any instrument, apparatus, machine, software, biomedical e:uipment or other similar or related articles, whether used alone or in combination, including components, parts, accessories and software necessary for proper application