INVIMA adds to list of medical devices requiring registration in Colombia

Colombian Regulators Set August 2014 Deadline for Medical Device Registrations

December 06, 2013 by Stewart Eisenhart

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.

Stewart Eisenhart

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INVIMA, Colombia medical device registration and approval

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Colombian Regulators Set August 2014 Deadline for Medical Device Registrations

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