Dec 6, 2013
Colombian medical device market regulator INVIMA has set a deadline of August 11, 2014 for registration of more than 30 types of medical devices previously exempt from market authorization requirements.
Registration requirements for Colombia will go into effect for a diverse range of devices, including:
| Anti-bed sore mattresses | Lamps used in medical prodecures | Mechanical and electronic scales | Hospital beds |
| Sterile disposable surgical clothing | Laboratory pipettes | Diagnostic imaging systems | Disinfecting systems and solutions |
| Binocular microscopes | Microtomes | Tissue processing equipment | Blood component dividing equipment |
| Fluoride application trays | Breast milk extractors | Static bicycles, treadmills and elliptical steppers | Electric massage equipment |
| Disposable and non-disposable surgical field equipment | Acetate trays | Saliva ejectors | Isolating latex clothing and equipment |
| Micro brushes | Blood bank centrifuges | Molecular biology centrifuges | Immunoassay processors |
INVIMA has also set requirements regarding advertising and marketing of medical devices in Colombia according to their classifications. Class I devices may be advertised using mass media, while Class IIa, IIb and III devices used and prescribed by healthcare providers and professionals may only be advertised through scientific, trade or technical publications.
Medical device and equipment manufacturers who may be affected by these new medical device registration requirements in Colombia should consult the INVIMA document linked above to determine if they’ll need to obtain market authorization for their products in 2014.
Colombian medical device regulator INVIMA has eased some translation and grouping criteria for market registrants.
According to an INVIMA communication, Colombia registration materials pertaining to biocompatibility, risk analysis, sterilization, and clinical studies and test reports may now be submitted to reviewers in their language of origin; summaries of study descriptions, methods and conclusions must be provided in Spanish.
INVIMA, Colombia's medical device market regulator, has published an updated list of products that qualify as medical devices, expanding the pool of medical products that require market authorization to be legally sold in the country.