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:

Medical Device Regulatory / Standards GAP Analysis Report (English)
Medical Device Regulatory / Standards GAP Analysis Report (Portuguese)
Medical Device Regulatory / Standards GAP Analysis Report Summary Video (Spanish with English subtitles)
Medical Device Regulatory / Standards GAP Analysis Report – Standards Development Organizations – Supplemental Information

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.

REGULATORY COALITION PRINCIPAL MEMBERS