Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements for medical devices in major countries of Latin America

Dr. Kirsten Jacobs (Abschlußjahr: 2011)

EU, US and other countries of the "1st world" have very stringent regulations for importation and vigilance of medical devices in place. Such stringent regulations are not (yet) existing in many of the so-called “Emerging Markets”, including Latin American countries. However, medical devices are one of the major growth areas in the Health Care sector, and therefore it has been acknowledged by Governments in Latin America that it is one of their main responsibilities to protect their populations by providing access to safe and efficient medical devices .

Strong support to enable other countries to set up a proper regulatory system for medical devices is being given by the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO) including its Latin America regional office, the Pan American Health Organization (PAHO). The GHFT has been founded by medical device regulatory authorities and medical device trade associations from EU, US, Japan, Australia and Canada, in 1993. Its purpose is to encourage convergence in regulatory practices for medical devices […] via the publication and dissemination of harmonized guidance documents on basic regulatory practices.

The WHO and PAHO are is closely collaborating with the GHTF and with national health authorities to implement proper regulatory frameworks for medical devices in Latin America. This collaboration in combination with the fast development and increasing complexity of medical devices have triggered a lot of changes in health care regulatory systems for medical devices in the last 10-15 years in Latin America.

This master thesis presents the current regulatory environment for medical devices in main Latin American countries, and puts own experience obtained with registration of medical devices in relation to the current existing regulatory requirements. A summary of results on implementation of GHTF recommendation, and on current registration and dossier requirements are shown in Table 4, Table 5 and Table 6.

Several countries in Latin America, are on a good way to establish regulatory systems which provide patients easy access to safe medical devices, including a good pre-market evaluation and post-marketing surveillance and vigilance. However, in other countries parts or all of these factors are currently neglected. In addition, in some countries with well advanced regulations, e.g. Mexico and Brazil, a recent trend towards over-regulation can be observed, including a tendency to start double-certification of device manufactures by sending own inspectors to the manufacturers, instead of relying on EU & ISO certification, or to request very detailed technical data. The very detailed technical documentation together with long timelines for assessing a medical device dossier make it difficult to follow changes in devices at the same speed as done in EU, and Life Cycle management of a device is difficult for multinational companies with EU and Latin America presence.

A good strategy for multinational manufacturer to gain access to the Latin American market with a medical device which has been CE marked in Europe, and which is subject to constant changes during its life cycle management, is to provide minimal technical dossiers (= Chapter 1 of GHTF STED only) which include all requested information, but only to a level of detail that changes in a device in EU not necessarily need to be re-registered when exporting to Latin America. With this strategy only changes which have a direct influence on the label of a device must be notified or registered with Latin American authorities. In addition, multinational companies should work through PANDRH, a Latin American industry association, to foster implementation of GHTF recommendations in all countries.

Pages: 56