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
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

On July 1st, 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Outdated regulation

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.