Support the establishment of International Benchmarks for Emergency Use Authorizations (EUA) for Medical Technologies Primarily underpinned by global medical device regulatory converge
Establish the International Center for Emergency Regulatory Response Now implemented in the form of a COVID-19 Medical Device workstream under the Global Medical Technology Alliance (GMTA) and Global Diagnostics Alliance (GDA) working together with the IMDRF and GHWP
Establish a COVID-19 Medical Device Portal Providing critical information to medical device regulatory authorities to facilitate the elimination of COVID-19 medtech bottle necks
Specific MDRC Global Objectives
Tier 1 – GRP Implementation (Cross-Sectoral)
Tier 2 – Medical Device Sector-Specific Regulatory, Standards and Conformity Assessment Convergence
Tier 1: GRP Implementation (Cross-Sectoral) Phase One: Update GRP international reference and implementation guide Phase Two: GRP gap analysis Phase Three: GRP implementation (bilateral) Phase Four: GRP implementation (multilateral)
Tier 2: Medical Device Sector-Specific Regulatory, Standards and Conformity Assessment Convergence Phase One: Update MD sector-specific regulatory, standards, and CA convergence International Reference and adopt a core training curriculum Phase Two: MD technical regulations, standards and CA gap analysis Phase Three: MD technical regulations, standards, and CA implementation (bilateral) Phase Four: MD technical regulations, standards, and CA implementation (multilateral)
Project Countries: Indonesia, Viet Nam (plus benefits to others)
Tier 1: GRP Implementation (Cross-Sectoral) Literature Review and Stakeholder Assessment
Tier 2: Medical Device Sector-Specific Regulatory, Standards and Conformity Assessment Convergence Phase One: Stakeholder assessment Phase Two: COVID-19 Medical Device Regulatory Review Phase Three: Implementation (local consultations and multilateral sessions)
MDRC is a partnership between USAID and the American National Standards Institute (ANSI) in collaboration with AdvaMed and partners around the world to advance global medical technology regulatory convergence together with standards developing organizations as well as national and regional health, trade, and regulatory authorities. At the global level, the MDRC works through the Global Medical Technology Alliance (GMTA) and Global Diagnostics Alliance (GDA) and in conjunction with the International Medical Device Regulators Forum (IMDRF) and Global Harmonization Working Party (GHWP).The MDRC’s regional and national partners are listed on the respective regional pages of this site.
