Phase 1: Creation of Implementation Guide
AdvaMed worked closely with the International Medical Device Regulators Forum (IMDRF), the Pan American Health Organization (PAHO), the U.S. Food and Drug Administration (FDA), the Latin American Medical Technology Alliance (ALDIMED), and the Latin American In Vitro Diagnostics Alliance (ALADDIV) to create an easy-to-use reference list of the international benchmarks for medical device technical regulations, standards, and conformity assessment mechanisms. This reference is included under International Benchmark Reference Documents – Tier 2.
Phase 2: Assessment and Gap Analysis
Using the sectoral reference guide as a benchmark, the Standards Alliance worked with participating countries to conduct assessments of existing Good Regulatory Practices, Technical Regulations, Standards, and Conformance Mechanisms for the medical devices sector.
The gap analysis report including information on the relevant international and national standardization committees is available via the links below:
Phase 3: Bilateral Cooperation
Beginning with the development of the gap analysis, the Standards Alliance initiated work with each project country bilaterally to begin addressing the identified gaps with the international benchmarks.
Phase 4: Multilateral Cooperation
Beginning with the development of the gap analysis, the Standards Alliance initiated work with the project countries multilaterally to begin addressing the identified gaps with the international benchmarks. AdvaMed formally connected the Standards Alliance with the Pan American Health Organization annual meeting of medical device regulators, sharing best practices on medical device-specific good regulatory practices, technical regulations, standards, and conformity assessment policy implementing teams from participating countries.