From North throughout Latin America, Medical DevicesEvolution of regulatory requirements is ongoing in Latin America. And at par with advances in traetmen, symptom control, and medical devices in some regions of Latin America are advancing at faster rate than in other world regions, and herein noting...

    Argentina - advances in medical device regulations based on European influence and US modeling... "Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)" Resolution 256 (verify for latest version). Argentina investment in the health care sector is the highest among Latin American countries (estimated yearly in $20 billion+). This represents 7+% Argentine GDP which translates to approximately $600 per capita. The health care sector continues growth, and expecting to continue at a rate of 8-10 percent within the portal of this XXI Century.

  • Brazil - Like Argentina it advances with a population size almost 8 times of Argentina... Brazilian law 6.360/76 decree 74.094/97
  • Mexico - heavily influenced by a large consumer market across its northern border, the USA and its regulatory requirements include regulations under the Secretaría de Salud which must meet Mexican standards (e.g., foley catheters) including Spanish language labeling (Castillian-Spanish labeling is required for all Spanish Latin American countries, Brazil requires it in Brazilian-Portuguese)
  • Chile - Is growing also,
  • Puerto Rico - US FDA regulated
  • US Virgin Island - US FDA regulated (yet after Cat. 5 Hurricane Maria in 2017), the paradigm may change
  • Canada - Canadian Health Care
  • Malaysia - Malaysia Medical Devices

Product registration is important as early as possible, because while some countries are not currently enforcing regulations they will and most likely products in the system already are likely to be "grandfather". For this to happen either you have a distributor or you have an office/base of activity.

Keeping an "eye" on the regulatory changes of your market of interest is key. Further, the MercoSur is a free-trade agreement between the most of the key countries in South America (Brazil, Argentina, Uruguay, Paraguay with Chile and Bolivia as associate states). The MercoSur countries have initiated the implementation of a scheme similar to that of the CE Mark (see European Directive updated version of 93/42/EEC - MDD).



Growth in the medical sector and device related is resultant of political stability and thus investing in the care of its citizen. This leads to new hospitals which in turn need equipment, professionals and thus growth in the health related infrastructure.

Further, a private sector is evolving, while public health care still provides the vast majority of services. This requires clinics, more hospitals, pharmacy, suppliers, manufacturers, service providers... Et all increasing the size of the medical devices supply-chain.

US and European products in the health sector enjoy excellent reputation. This reputation and confidence Surgery, medical services... through out the consumers, users, patients and health care providers is due to product safety, controls, quality and timely delivery.

Nevertheless, ISO 13485 is a positive step toward adhering to laws and regulations.


Regulations Latin AmericaBack to Home Portal...