Action Plan (2020-2025)

The first stage in the development of the action plan involved the definition of priority issues that were classified in two categories:

1. Regulatory Process

Crisis Management Preparedness – Post COVID19 – Regulatory Framework

Prioritized use of international standards – baseline for new regulations – IMDRF, ISO, etc. (21st Century Cures)

GRP implementation policy – RIA implementation

Agreement for Reliance – Approvals recognition

WTO – TBT Committee Commitments

GRP Legislation

Designation of a standards & conformity assessment: executive/program – Health Regulators

Designation of a standards responsible – MedTech Associations

2. Technical Regulations

Regulation of SaMD

Use of MDSAP / In-country Implementation

UDI/GMDN

Risk Classification of MDs

Labeling: Legal Manufacturer, Country of Origin, Physical Manuf., Storage Temp., Exp. Dates, local re-labeling

Electronic Submissions eIFU + eSignatures

Medical Device Definition

Technovigilance

On July 1^st, 2020, during the First Virtual Meeting of the Coalition, Principal Members presented their projects.

The Projects related activities developed by the Technical Secretariat were:

Step 1: Grouping of Projects according to priorities

Step 2: Identification of common issues

Step 3: Discussion with the members

Step 4: Implementation

Every action plan was analyzed as to identify whether the cause was:

Absence of regulation

Country-specific requirements

Outdated regulation

Action-Plan

It was identified that the root cause of most regulatory problems experienced by the members begins with conducting inadequate regulatory processes.

Thus, the Technical Secretariat proposed to their Principal Members to hold tailor-made training in each country to further develop capacities among all related stakeholders on good regulatory practices, with the objective to ensure the creation or update of any technical regulation fulfills the local legal requirements as well as the countries treaties obligations.

1. Regulatory Process

2. Technical Regulations

REGULATORY COALITION PRINCIPAL MEMBERS