International Medical Device Agency

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Latin American Norms of medical devices Mr. Antonio Hernández, September 2012

In his second installment, the author presents some particularities of medical device regulation in Latin America, with emphasis on emerging character and makes room for a discussion on the need to implement evaluation and monitoring mechanisms.

The Latin American norms of medical devices generally follows the guidelines of international standards for these products. This is because most programs of medical device regulation in Latin America and the Caribbean are newly organized and taken as the reference structure, definitions and guidance documents produced by the "Harmonization Task Force on Global Level" or " GHTF "(for its acronym in English). [1] Information on international standards for medical devices is available in the article published in the February / March 2012 The Hospital.

For the implications and impact on the health of the population, it is the responsibility of the state to ensure that medical devices sold and used in the country are effective, safe and quality. To this effect the countries have regulatory agencies or programs of medical devices, usually associated with or dependent health ministries. During the process of health sector reform that occurred in Latin American countries by the end of the last century, emerged as critical the need to strengthen the regulatory capacity of the state in the areas of food and health products. The regulation has been tagged as one of the essential public health functions and countries increased their efforts to develop and strengthen these programs, nationally and collectively through agreements and regional forums in collaboration with the Pan American Health Organization (OPS).

The regulation of medical devices does not have the experience and level of development programs regulating food, drugs and cosmetics. A majority of countries have agencies or agencies with capacity to implement programs and monitor the products mentioned. This aspect coupled with the fact that most countries are net importers of medical devices and thus technology dependent for its supply has meant that governments have given priority to strengthening its capacity to regulate medical devices. There are a number of factors that have determined the need for agencies or programs of medical device regulation. Some of them are:

• Rapid technological development in health is reflected in high complexity and high cost generally. These devices are incorporated permanently in health services.

• The growth of domestic industries to produce or assemble medical devices. Both for domestic consumption and for export, and the need to comply with the rules, standards and quality controls required to ensure their effectiveness, safety and quality.

• The impact of the convergence of the "Information Technology and Communications (ICT)" to health technologies that are changing the traditional setting of the devices as individual units for systems of networked computers.

• The incorporation of computer programs to support decision making and clinical management - including electronic medical records - which are registered as medical devices.

• The growing supply of products manufactured in emerging economies and those who do not have enough information.

• The sale of used and refurbished equipment and the need for verification of compliance with original manufacturer specifications and comply with the rules and standards.

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The threat of international terrorism is surely severe. The horrendous events of Sept. 11 had perhaps the most devastating instant human toll on record, outside of war. The word 'instant' should not be overlooked; regrettably, the crime is far from unusual in the annals of violence that falls short of war. The death toll may easily have doubled or more within a few weeks, as miserable Afghans fled -- to nowhere -- under the threat of bombing, and desperately-needed food supplies were disrupted; and there were credible warnings of much worse to come.
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