On January 24-25, 2017, the Standards Alliance - a partnership between the American National Standards Institute (ANSI) and the U.S. Agency for International Development (USAID) - teamed up with the National Institute of Quality (INACAL) and the ASTM Latin America Office for Phase II of the "Peru Workshop on Medical Devices Regulations and Standards: Policy and Technical Aspects" in Lima, Peru. The event was a follow-up to the first medical devices workshop which took place in November 2015 and focused on the implementation of medical devices quality management systems, quality control, and a technical training on biological test methods.
The Standards Alliance is a public-private partnership between ANSI and USAID, and is focused on implementation of the WTO TBT Agreement in developing countries.
Over 55 Peruvian participants attended the January workshop, representing the private and public sector. Six representatives provided the U.S. perspective including: Dr. Terry Woods, solid mechanics laboratory leader, U.S. Food and Drug Administration (FDA); Dr. Spiro J. Megremis, director of the Research and Laboratories Science Institute, American Dental Association (ADA); Brian Berg, senior research fellow, Boston Scientific; Dawn A. Lissy, founder and president, Empirical Technologies; Stephen Spiegelberg, president, Cambridge Polymer Group; and Jessica Roop, international policy manager, ANSI.
The National Institute of Quality (INACAL), Medicines, Supplies and Drugs (DIGEMID), Ministry of Foreign Trade and Tourism (MINCETUR), National Institute of Health (INS), and Peru Compras provided Peruvian viewpoints and feedback.
The workshop addressed key topics including:
An overview of medical device regulations, standards, and conformity assessment in the United States and Peru with a focus on eliminating unnecessary barriers to trade;
Best practices in forging regulations and the use of standards for medical technology products;
Safety and health issues including level of risk classifications for medical devices and the effectiveness of standards in supporting these objectives;
Technical standards in public purchases and the challenges of medical device quality control;
ASTM International's standardization processes, technical committees and material test methods for assessing and evaluating the performance of orthopedic devices; and cardiovascular devices and test methods for analytical testing and assessing device cleanliness.
A detailed look at inter-laboratory testing and the evolution of standards in dentistry.
The workshop also included several Q&A sessions and an in-depth panel discussion, which provided an opportunity for participants to ask specific questions. U.S. representatives shared their individual experiences in the field and provided additional insight and follow-up information to their presentations.
Ongoing work with Peru under the Standards Alliance continues to underscore the heightened importance of the collaborative relationship between ANSI, its members, and its Peruvian counterparts, both in the public and private sectors. Prior to the workshop, ANSI staff had the opportunity to meet with commercial specialists at the U.S. Embassy in Lima, Peru, as well as INACAL staff in a separate meeting to discuss ongoing and future opportunities for both Peru and the U.S. stakeholders.
Opportunities include further medical device training, support for a water resource initiative, capacity training on quality of petroleum, diesel and gasoline, and the need for U.S. speakers for an upcoming cosmetics event taking place in Peru regarding the recent decree moving regulatory responsibility for pharmaceuticals, vitamins, and cosmetics from Peru's DIGEMID (General Directorate of Medicines, Supplies and Drugs) to DIGESA (General Directorate of Environmental Health).