|Medical Devices Regulation|
The Latin American and Caribbean Countries (LA&C) in the PAHO region have a population of approximately 582,390 million.
This population has created a rapidly growing market for medical devices. The importing of medical device has been growing at an average annual rate of 10% in the LA&C countries. These countries, almost of all them, technology dependant, typically import more than 80% of the medical devices that they use.
Currently, there is a broad spectrum of the levels of “maturity” of the systems for device regulation in the countries, from those that lack laws, regulations, and standards that address medical devices to others that have adapted and implemented more advanced regulatory systems that specifically pertain to these products.
Many of the countries have not established regulatory systems specific to medical devices to control devices that find their way into their healthcare facilities and into the hands of physicians, patients, and the general population.
As the world becomes a global marketplace, there is an emphasis on becoming members of, and having an active presence in, the Global Harmonization Task Force (GHTF) http://www.ghtf.org Because of the emerging market for medical devices in these countries, there is an interest in enhancing the regulatory responsibilities of the LA&C countries within the context of international harmonization.
PAHO has organized the LA&C countries into a “block” and encouraged them to take an active role in the meetings of the GHTF and using as reference for their legislation the final guidance documents of their five study groups (SG). It has also organized and facilitated meetings of the Pan American Cooperation on Medical Equipment (PACME) – Ad-Hoc Group of the Medical Devices Regulatory Authorities of the Member States - to address harmonization efforts and the strengthening of the regulatory systems for medical devices in those countries.
With protection of the health and safety of the public as the primary guiding principle, PAHO in partnership with the U.S. Food & Drug Administration, Medical Devices Bureau/Health Canada and the Emergency Care Research Institute strive to ensure the safety, efficacy, and quality of the medical devices in the health facilities, public and private, as well as those in use by physicians, patients, and the general population of the member countries.
To accomplish this goal, since 1994, PAHO has developed guidelines, background documents, and a proposed action plan, held a consultation meeting, and, as previously mentioned, is an active participant/organizer in meetings of the GHTF, and PACME.
Pursuant to Resolution CD42.R10 on Medical Devices from the 42nd Directing Council, part of PAHO’s mandate in this area includes:
Also, PAHO’s Work plan for echoes these mandates.
PAHO and its partners will continue to provide technical assistance and training to:
One of the key aspects in the regulation it’s to have a clear understanding of the term “medical device”. To start the program, each of the LA&C countries has or need to have defined the term.
The countries need to draft and enact legislation that will allow them to make an informed decision on the safety, efficacy, and quality of the devices that they wish to import, the suitability of the importing manufacturers, and the conditions and practices of their own importers and distributors.
The primary elements of an effective regulatory process include:
Concerning the manufacturing controls and inspections, these would be tailored to the operations of the firms and products under scrutiny. Good Manufacturing Practices apply to manufacturers located within the country (some countries require that importers certify that the products were manufactured in compliance with such regulations). Since most of the countries predominantly import a large proportion (over 80%) of the medical devices, controls for imported devices would extend to the storage and handling of devices after they are received from other countries.
In order to increase the ease and efficiency of product acceptance, both by the member countries and those with whom they trade, these systems need to be structured in accordance with the guidance and policy developed by the four study groups of the GHTF.
PAHO’s technical cooperation has been focused on:
Regional Office for the Americas of the World Health Organization