Another Attempt to Globalize the Medical Device Industry

When it comes to a globalized economy, one obstacle always bothers the free trade: the regulatory systems of the countries. To stimulate the global economy and favor the free international trade, it is important to think of a way to converge rules and so, the free movement of goods will not become a slow bureaucratic process. As for a harmonized regulatory system for medical devices, the task is even harder because it also deals with national health laws.

This was the concern when in 1992 the European Union (EU), the United States, Canada, Japan and Australia gathered together to establish a method to harmonize the regulations on medical device. The voluntary group was called Global Harmonization Task Force (GHTF) and brought together representatives from medical device regulatory agencies and the regulated industry from its founding members.

Almost 20 years later, the new economic scenario called for new representatives. So, “to build on the strong foundation work of the GHTF and to accelerate international medical device regulatory harmonization and convergence”, the International Medical Device Regulators Forum (IMDRF) was conceived in February 2011, replacing the GHTF. Besides the original 5 founding members of the GHTF, it included Brazil to the discussion of future directions in forming an international harmonized and convergent regulatory system for medical devices.

The membership of China and Russia are currently being confirmed and the new Forum, including the 6 official members, China and the WHO (World Health Organization, an observer member), met in Ottawa in October 2011 to establish strategic topics for its operation.

Trying to standardize rules among the GHTF member countries was a big challenge, now with the creation of the IMDRF and new members added, the debate becomes even harder. Despite the adversity, the future results might turn out to be stronger and more creative once it takes into consideration different points of view. There is still a long way of hard work to build a harmonized and convergent regulatory system, which provides solutions to all the five countries and EU’s concerns. We hope the members create an environment of dialog to accelerate the harmonization and convergence of their regulatory systems, so that we could have a real “international medical device regulatory system”.

References: http://www.imdrf.org/

Brazil and the Global Harmonization Task Force (GHTF)

According to the FDA, the Global Harmonization Task Force (GHTF) fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.

The GHTF was founded in 1992 and its main purpose is to standardize medical device regulations around the world by the exchange of information. Some of the benefits of the standardization are the convergence in regulatory practices related to ensuring safety and facilitating international trade.

On November 11, Brazil, Argentina, Colombia and Cuba’s regulatory agencies agreed to work in cooperation, through the inspection of manufacturers of medical devices in each country. The Brazilian regulatory agency (ANVISA) requires a Good Manufacturing Practices (GMP) certification from medical devices manufacturers, and the inspection is conducted by the agency itself. From January of 2013 the GMP certification issued by the Argentinean, Colombian, and Cuban agencies will be accepted in Brazil as well, which means more efficiency in the certification process.