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REGULATORY COHERENCE & CONVERGENCE PROJECT FOR THE MEDICAL DEVICE SECTOR


AdvaMed logo The Advanced Medical Technology Association (AdvaMed) Standards Alliance Project 1.0 has assisted Latin American governments with the implementation of cross-sectoral good regulatory practices (GRP) and also medical device sector-specific regulatory convergence. The primary objective of the project has been to provide private sector expertise and resources in support of international, regional, sub-regional, and national governmental initiatives to adopt GRP including regulator use of international standards. The AdvaMed Standards Alliance Project 1.0 has promoted good regulatory practices and provided capacity building assistance for governments across Latin America, including Colombia, Mexico, Peru, and CAFTA-DR countries (Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Dominican Republic).

The project has emphasized the adoption of internationally recognized best practices as well as the implementation and reinforcement of policies promoting the use of international standards and conformity assessment mechanisms as bases for regulations. Creating a firm foundation of internationally excepted regulatory practices has helped ensure that technical barriers to trade between patients and life-saving and life-improving medical technologies across the Americas are minimized while simultaneously improving regulatory efficacy, administrative efficiency, market access and international confidence in Latin American markets.

KEY OUTCOMES AND DELIVARABLES

The AdvaMed Project 1.0 is separated into two tiers to address both horizontal and vertical regulatory issues. Tier 1 emphasizes implementation of international good regulatory practices as they apply transversely across all government regulators of different sectors. Tier 2 focuses on the implementation of good regulatory practices, technical regulations, standards and conformity assessment as they apply to medical device regulatory agencies.

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, the Standards Alliance 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 provides an overview of good regulatory practices for governments and stakeholders including:

  • Key GRP definitions and checklist
  • GRP policy landscape survey
  • Regulatory Impact Assessment questions.

The guide is available in English, Spanish and Portuguese.

More information is included below under International Benchmark Reference Documents – Tier 1



completed

PHASE 2: Assessment and Gap Analysis

Using the implementation guide as a benchmark, the Standards Alliance conducted an assessment of the GRP policies in Colombia, Costa Rica, Mexico, Peru and the United States, gauging their consistency with international best practices.

The GRP GAP analysis summary videos are available below (English):



completed

PHASE 3: Bilateral Cooperation

Following the completion of the gap analyses, the Standards Alliance initiated work with each project country bilaterally to begin addressing the identified gaps with the international benchmarks.



completed

PHASE 4: Multilateral Cooperation

Following the completion of the gap analyses, the Standards Alliance initiated work with the project countries multilaterally to begin addressing the identified gaps with the international benchmarks. AdvaMed formally connected the Americas Business Dialogue Regulatory Working Group with the Inter-American Development Bank Ibero-American and Caribbean Regulatory Improvement Network, sharing best practices of GRP policy implementing teams between the project countries.


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


completed

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 below under International Benchmark Reference Documents – Tier 2.



completed

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:



completed

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.



completed

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.


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 guide provides a landscape of international Good Regulatory Practice (GRP) policies and definitions and implementation checklist for senior policy-makers. GRP, also known as “Regulatory Coherence”, “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. GRP is the minimum set of policies that governments adopt horizontally across all of its agencies to ensure that the entire public administration of a country implements rulemaking in a consistent manner. A foundational GRP policy allows sector-specific Regulatory Convergence efforts, including international standards harmonization, to reach their full potential.

      Contents include:

      • Good Regulatory Practice Checklist
      • Regulatory Impact Assessment Checklist
      • GRP International Policy Survey

      English / Spanish / Portuguese

  • Good Regulatory Practices

    • Ensure transparency and stakeholder involvement in the development of regulations:
      • Produce regulatory forecasts.
      • Maintain a National Regulatory Register.
      • Provide advanced notice of proposed rulemaking. d) Provide opportunities for public comment.
      • Publish evidence or regulatory analysis which supports a draft rule.
      • Address and respond to stakeholder input. g) Ensure a reasonable period for the entry into force of regulations.
    • Use valid, reliable data and sound science to guide the rule-making process.
    • Use valid, reliable data and sound science to guide the rule-making process.
    • Conduct Regulatory Impact Assessments (RIAs) (pre- regulation implementation).
    • Assess a regulation’s impact on market competition.
    • Assess a regulation’s international impact.
    • Maximize the use of relevant international standards
    • Leverage private sector conformity assessment mechanisms.
    • Enable stakeholders to request an independent judicial review of regulation.
    • Conduct ex-post assessments of a regulation’s impact (post-regulation implementation)
    • Identify a central coordinating body which is able to ensure whole-of-government implementation of the above principles.

  • World Trade Organization

    • WTO TBT Agreement Text (English, Spanish)

      The World Trade Organization – Technical Barriers to Trade Agreement constitutes the international law and binding legal obligation that each member country use international standards as a basis for national technical regulations, that technical regulations not be more trade restrictive than necessary, and that outdated technical regulations be updated or withdrawn.

      Technical Regulations and Standards

      Article 2: Preparation, Adoption and Application of Technical Regulations by Central Government Bodies

      2.2 Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create…

      2.3 Technical regulations shall not be maintained if the circumstances or objectives giving rise to their adoption no longer exist or if the changed circumstances or objectives can be addressed in a less trade-restrictive manner.

      2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations…

    • Supporting the TBT Agreement with Good Regulatory Practices Implementation Options for APEC Members
    • G/TBT/Rev 8 Section IX

      The WTO Committee on Technical Barriers to Trade adopted a set of principles to which an organization engaged in the development of international standards must comply. These principles have been captured in document “G/TBT/ 1/REV. 8. Section IX,” titled Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with Relation to Articles 2, 5 and Annex 3 of the Agreement.


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.

FDA MEDICAL DEVICE PROGRAM REFERENCE DOCUMENTS


RECOMMENDED GRP IMPLEMENTATION POLICY FOR MEDICAL DEVICE REGULATORY AGENCIES

  • Agency documentation of WHO, OECD, WTO implementation
  • Agency search for relevant international standards as a pre-step to drafting regulation
  • Agency use of relevant international standards
  • Agency participation in (international) standardization
  • Agency Regulatory Impact Assessment
  • Agency ex-post review
  • Agency publication of standards use
  • Agency designated of position responsible for implementation of the above

ADDITIONAL INFORMATION