Standards AllianceUSAID and ANSI logos USAID.gov American National standards Institute
Standards Alliance Prticipating Countries About Standards Alliance Standards Alliance Activities Alliance Activities News and Publications Alliance Activities News and Publications
Indonesia Peru Central America Columbia East Africa Middle East Southern Africa West Africa Asean Yemen Mexico
Upcoming Standards Alliance Events

REGULATORY COHERENCE & CONVERGENCE PROJECT FOR THE MEDICAL DEVICE SECTOR


AdvaMed logo The Advanced Medical Technology Association (AdvaMed) Project aims to help Latin American governments maximize regulatory efficiency in the medical devices sector. The primary objective of the project is to provide private sector expertise and resources in support of international, regional, sub-regional, and national governmental initiatives to adopt good regulatory practices. The AdvaMed Project promotes regulatory coherence, encourages good regulatory practices, and provides capacity building assistance for governments across Latin American, including Colombia, Mexico, Peru, and CAFTA-DR countries (Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Dominican Republic).

The project emphasizes the adoption of internationally recognized best practices as well as the implementation and reinforcement of policies promoting the use of internationally harmonized voluntary consensus standards and conformity assessment mechanisms. Creating a firm foundation of internationally excepted regulatory practices will ensure U.S. medical device manufacturers and others retain market access while bolstering international confidence in Latin American markets.

KEY OUTCOMES AND DELIVARABLES

TIMELINE OF ACTIVITIES

The AdvaMed Project is separated into two tiers to address both horizontal and vertical regulatory issues in the medical devices sector. Tier 1 emphasizes regulatory coherence across government agencies benchmarked across international best practices, while Tier 2 highlights good regulatory practices, technical regulations, standards and conformance within the medical devices sector.

TIER 1: GOOD REGULATORY PRACTICES (GRP = REGULATORY COHERENCE)



THE BRIDGE TO COOPERATION: GOOD REGULATORY DESIGN

PHASE 1: Creation of Implementation Guide; April 2017

In April 2017, AdvaMed, in close collaboration with a variety of government and international organizations, developed and published an implementation guide entitled, “The Bridge to Cooperation: Good Regulatory Design.” The guide outlines best regulatory coherence practices and serves as an overview for governments and stakeholders alike including foundational standards and conformity assessment policies. The guide has been translated into both Spanish and Portuguese.



July 2018

PHASE 2: Assessment and Gap Analysis

Using the implementation guide as a benchmark, AdvaMed is currently working with Costa Rica, Colombia, Mexico, and Peru to conduct an assessment of existing regulatory coherence policies and their consistency with international best practices. Once each assessment is complete, AdvaMed will produce a gap analysis report for each country in both English and Spanish.



completed

PHASE 3: Bilateral Cooperation

Following the completion of country-specific gap analyses, AdvaMed will create and execute implementation plans for each project country.



July 2018

PHASE 4: Multilateral Cooperation

Once the implementation phase has been completed, the Standards Alliance and AdvaMed will establish a forum to share best practices during regularly scheduled meetings between Regulatory Coherence policy implementing teams from participating countries


TIER 2: SECTOR-SPECIFIC GOOD REGULATORY PRACTICES, TECHNICAL REGULATIONS, STANDARDS, AND CONFORMITY ASSESSMENT


completed

PHASE 1: Creation of Implementation Guide

AdvaMed is working closely with the International Medical Device Regulators Forum (IMDRF), the Pan American Health Organization (PAHO), the U.S. Food and Drug Administration (FDA), the U.S. Trade Representative (USTR), Latin American Medical Technology Association (ALDIMED), and Latin American In Vitro Diagnostics Association (ALADDIV) to create a formalized and easy-to-use reference guide on technical regulations, standards, and conformance mechanisms for the medical devices sector. This reference guide has been translated into English, Spanish, and Portuguese.



July 2018

PHASE 2: Assessment and Gap Analysis

Using the sectoral reference guide as a benchmark, AdvaMed will work with participating countries to conduct assessments of existing Good Regulatory Practices, Technical Regulations, Standards, and Conformance Mechanisms for the medical devices sector. Once each assessment is complete, AdvaMed will create a gap analysis report for each country in both English and Spanish.



completed

PHASE 3: Bilateral Cooperation

Following the completion of country-specific gap analyses, AdvaMed will create and execute implementation plans to address sector-specific issues in each project country.



July 2018

PHASE 4: Multilateral Cooperation

Once the implementation phase has been completed, the Standards Alliance and AdvaMed will establish a forum to share best practices between Medical Device Good Regulatory Practices, Technical Regulations, Standards, and Conformance policy implementing teams from participating countries.


INTERNATIONAL BENCHMARK REFERENCE DOCUMENTS


Tier 1 – Global Benchmark Documents – Overarching Good Regulatory Practices and Technical Barriers to Trade Requirements


Good Regulatory Design (GRP / Regulatory Coherence) Policy Guide and Implementation Manual

  • Global Regulatory Cooperation Center

    • This guideline provides a landscape of international “Regulatory “Coherence” policies and definitions and implementation checklist for senior policy-makers. “Regulatory Coherence”, also known as “Good Regulatory Design” or “Regulatory Reform”, is a horizontal, whole-of-government policy, managed at the top executive level of government, implementing the binding rules by which regulatory agencies generate regulations. Regulatory Coherence is the minimum package or set of Good Regulatory Practices (GRPs) that governments adopt horizontally across all of its agencies to ensure that the entire public administration of a country implements GRP in a consistent manner. Foundational Regulatory Coherence policy allows sector-specific Regulatory Convergence efforts, including international standards harmonization, to reach their full potential.

      Contents include:

      • GRP Checklist
      • RIA Checklist
      • GRP Policy Survey
      English / Spanish / Portuguese


Tier 2 – Global Benchmark Documents – Medical Device Sector Regulatory Frameworks, GRPs, Regulations, Standards, Conformity Assessment mechanisms


WHO Global Model Regulatory Framework for Medical Devices Including IVD Medical Devices

  • World Health Organization

    • This document is intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries. This WHO Global Model Regulatory Framework for Medical Devices including IVD medical devices (the Model) provides a basis for such work.  The Model recommends a progressive, or stepwise, approach to regulating the quality, safety and performance of medical devices. It provides guidance for a staged development of the regulatory system from basic level controls - such as the publication of the law and resourcing the regulatory authority to undertake enforcement actions – to expanded level controls – such as inspection of registered establishments and oversight of clinical investigations.

WHO Good Regulatory Practices: Guidelines for national authorities for medical products

  • World Health Organization

    • This guideline outlines internationally accepted principles of GRP and shows how they may be applied to the regulation of medical products for human use. The guideline is intended for a number of related audiences: institutions and senior policy-makers responsible for the formulation of health policies, laws, regulations and guidelines; staff in institutions that, together, form national systems for regulatory oversight of medical products; and parties affected by or otherwise interested in regulatory frameworks, such as civil society and the regulated industry. This document is intended to assist Member States in the implementation of GRP, both in establishing new regulatory systems for medical products and in updating existing ones.

IMDRF documents


AHWP Playbook for Implementation of Medical Device Regulatory Frameworks

  • Asia Harmonization Working Party

    • The information provided in this playbook is primarily based on the Global Harmonization Task Force (GHTF) guidance documents and approach. The playbook is intended to guide regulators in the understanding and implementation of an efficient and cost-effective medical devices regulatory system.

ISO 16142-1 (First Edition 2016)

  • Medical Device – Recognized essential principles of safety and performance of MDs – Part 1 (non-IVD)

    • This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). This part of ISO 16142 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices.

ISO 16142-2 (First Edition 2017)

  • Medical Device – Recognized essential principles of safety and performance of MDs – Part 2 (IVD)

    • This document, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This document identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).  This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices.

FDA MEDICAL DEVICE PROGRAM REFERENCE DOCUMENTS


ADDITIONAL INFORMATION