Colombia's regulatory system for medical devices is characterised by a complete set of regulatory controls that covers both pre-market and post-market activities.As is the case of the other Latin American countries that have implemented medical device regulations, Colombia's system is influenced by the guidelines of the World Health Organization and the Pan American Health Organization, which recommend use of Global Harmonization Task Force parameters and the experience of the regulatory models of certain developed countries such as the US and the EU.The Colombian regulatory system is also characterised, however, by lengthy review times. But the system is evolving and the country has been taking steps to make it easier for companies to register their products.
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