Registro Sanitario para Dispositivos Medicos

Colombia, México and Cuba sign the  Acapulco Declaration  for Medications and Medical Devices for the Sanitary Regulation benefit.


What you just read is correct. The following three regulatory entities: The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) from Mexico, The National Institute for the Vigilance of Medications and Food (INVIMA) from Colombia and the Center for the State Control of Medications, Equipment and Medical Devices (CECMED) from Cuba have signed this Declaration in order to create the Medications and Medical devices Regulatory Agency of Latin America and the Caribbean (AMLAC). The invitation was extended also to the Regulatory Authorities of Argentina, Brazil, and Chile.

The formation of this agency has as its objective to promote the self-sufficiency, harmonization, and optimization of processes in respect of the sanitary regulation for medicine and medical devices, which in our opinion would have the same operation to the one established for the cosmetic, cleaning and maintenance products Commercialization, currently used by the Countries member of the Andean Community.

Undoubtedly, this carries a compromise and responsibility from the entities in the pursuit of a greater benefit in the health of many and not only for emergency cases as was the case with the pandemic of Covid-19, as unquestionably this type of initiatives leads to have fastest and safest access to high quality products that can mitigate   these type of adverse events for the health. They aim to be dealt with in a more efficient way and to promote recognition before other Countries to this type of initiatives.

The important questions are now: How will the efficiency in the request for sanitary Products is going to be materialized? Less time? The same documentation? Will there be standardizations?

We will be informing all the developments as they come before us, as some meetings will take place in the month of May in Bogotá and in the month of June in Habana to conclude the pending issues.

Practical and timely solutions

(+57) 350 394 8463 

 (+571) 621 9721

How Cosmetics Are Regulated in the Iberoamerican Countries – Colombia Life Sciences law firm – Colombia FDA equivalent

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