The Colombian Secretary of Transparency relayed the following message at the ANDI Medical Device Forum in Bogotá Colombia November 2018: the longer that it takes any government agency to conduct its function, and the more that it deviates from the use of international standards, the higher the perception – and margin – for unethical conduct.

The global medical technology sector is dedicated to removing barriers between patients and life-saving and life-improving medical technologies. The Coalition estimates that a lack of good regulatory practices across Latin America is responsible for regulatory inefficiencies equivalent to a 20% import tariff. The Coalition also estimates that the lack of ethical business conduct and consistently enforced anticorruption measures are responsible for costs ranging from a 10 to 30 percent import tariff.

Medical device regulatory convergence, made possible through the use of international standards and implementation of foundational good regulatory practices, is the single most effective public policy objective that the public and private sectors can pursue, in a meaningful and pragmatic form, to simultaneously increase transparency, improve regulatory efficacy, improve public administrative efficiency, and to reduce regulatory divergences, delays and costs which are incurred by patients, public health systems, and the medical technology industry.