The Standards Alliance, in collaboration with the Advanced Medical Technology Association (AdvaMed), has been working to implement a project aimed at helping Latin American governments maximize regulatory efficiency in the medical devices sector. The project emphasizes the adoption of internationally recognized best practices as well as the implementation and reinforcement of policies promoting the use of internationally harmonized voluntary consensus standards and conformity assessment mechanisms.
Initiated in 2016, the AdvaMed project aims to promote regulatory coherence, encourages good regulatory practices, and provides capacity-building assistance for governments across Latin America, including Colombia, Mexico, Peru, and CAFTA-DR (Dominican Republic-Central America FTA) countries: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Dominican Republic. The project comprises two tiers to address both horizontal and vertical regulatory issues in the medical devices sector: Tier 1 emphasizes regulatory coherence across government agencies benchmarked across international best practices, and Tier 2 highlights good regulatory practices, technical regulations, standards, and conformance within the medical devices sector.
On January 19, 2018, the Standards Alliance, in partnership with AdvaMed, organized a one-day Workshop on "Regulatory Convergence and International Standardization" at AdvaMed's Washington, DC office. As part of this initiative, 11 representatives from the Colombian National Food and Drug Surveillance Institute (INVIMA) attended in-person meetings in New Jersey and Washington, including a roundtable meeting with AdvaMed and the American National Standards Institute(ANSI) to review the results of the Standards Alliance project to date, and to address select regulatory topics that could benefit from increased regulatory convergence.
The Standards Alliance has been working to increase the use of International Medical Device Regulators Forum (IMDRF) documents and international standards by medical device regulators in Latin America over the past several months. As a component of this initiative, the Standards Alliance encouraged medical device regulators, particularly from Colombia and Mexico, to be more engaged in IMDRF work. After holding regional workshops with the Pan American Health Organization (PAHO) in September 2017, and working in conjunction with the Colombian counterpart medtech association ANDI-CDMIS, the Colombian MD regulatory agency, INVIMA, agreed to participate in the Standards Alliance initiative and send a delegation for the January 19 workshop.
More than 25 people representing U.S. public- and private-sector organizations attended the workshop. U.S. speakers represented the U.S. Food and Drug Administration (FDA), ANSI, AdvaMed, Johnson & Johnson, the Association for the Advancement of Medical Instrumentation (AAMI), and ASTM International. Speakers from Colombia included public-sector participants from INVIMA.
Presentations from Colombia provided an overview of Colombia's health standardization, medical device regulations, and INVIMA's experiences in premarket surveillance. Presentations also focused on topics in medical device regulation that can benefit from increased regulatory convergence and use of international standards. Some key outcomes and requests included the following:
-Request to institutionalize regular delegation visits;
-Request to support potential work with non-Standards Alliance countries including Guatemala, Honduras, and Nicaragua through in person meetings, virtual trainings, and funding opportunities;
-Agreement to advance a GRP policy implementation plan.