A Review of Foundational Good Regulatory Practices in Brazil, Colombia, Ghana, Indonesia, Kenya, Mexico, Peru, South Africa, and Vietnam: Horizontal aspects as they pertain to Medical Technology Regulation

The project's overarching objective is to accelerate coordinated medtech sector, supply chain, trade, and regulatory efforts to combat and recover from the COVID-19 pandemic in alignment with foundational good regulatory practices, including the use of international standards. The MDRC project focuses on building capacity of partner countries for standards and conformity assessment procedures related to medical devices, removing countries' technical barriers to trade for medical devices, increasing patients' access to needed high-quality PPE and other medical technologies, and fostering private sector engagement and co-responsibilities in public consultations and WTO notifications of draft technical regulations and standards regarding medical technologies. The project works through the Global Medical Technology Alliance, the Global Diagnostics Alliance, the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector, and in cooperation with the International Medical Device Regulators Forum, the Global Harmonization Working Party, and other global partners. The project countries include Ghana, Kenya, South Africa, Brazil, Colombia, Mexico, Peru, Indonesia, and Vietnam. Good Regulatory Practices (GRP) are foundational in the alignment of domestic regulatory frameworks, technical regulations, and standards with international standards. GRP accomplishes this by including as one of its core elements the prioritized use of international standards as a basis for national technical regulations, standards, and conformity assessment. The elements comprising GRP are defined multilaterally through the requirements and recommendations of the Organization for Economic Co-operation and Development and through the treaty-based obligations of the World Trade Organization Technical Barriers to Trade Agreement. The MDRC advances implementation of GRP within a two-tier architecture: Tier One focuses on implementation of foundational GRP as it applies to all sectors, including medical technologies, while Tier Two focuses on implementation of foundational and sector-specific GRPs by National Regulatory Authorities for medical technologies. This document is the Tier 1 Report measuring foundational GRP implementation across the project countries. The report benchmarks existing GRP policies in each project country against the existing GRP International References and Implementation Guide, which includes a GRP checklist of indicators synthesizing the GRP requirements of the OECD, the WTO TBT Agreement, and U.S. GRP policies. The report provides an initial assessment on the establishment and implementation of GRP in the project countries, identifying gaps to be used for the MDRC capacity building workstreams throughout the course of the project. The report considers the following indicators when assessing a country's existing GRP policies: ensuring transparency and stakeholder involvement in developing regulations, using valid, reliable data and sound science in the rulemaking process, placing risk assessment and risk management at the core of regulatory decision-making, conducting Regulatory Impact Assessments, assessing regulation's impact on market competition, assessing regulation's international impact, and maximizing the use of international standards.