{"id":59,"date":"2021-05-13T02:57:50","date_gmt":"2021-05-13T02:57:50","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=59"},"modified":"2022-03-24T11:26:08","modified_gmt":"2022-03-24T11:26:08","slug":"action-plan-2020-2025","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/coalition-action\/action-plan-2020-2025\/","title":{"rendered":"Action Plan (2020-2025)"},"content":{"rendered":"\n

The first stage in the development of the action plan involved the definition of priority issues that were classified in two categories:<\/p>\n\n\n\n

1. Regulatory Process<\/h2>\n\n\n\n
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Crisis Management Preparedness – Post COVID19 – Regulatory Framework<\/span><\/div><\/div><\/div>\n\n\n\n
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Prioritized use of international standards – baseline for new regulations – IMDRF, ISO, etc. (21st Century Cures)<\/span><\/div><\/div><\/div>\n\n\n\n
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GRP implementation policy – RIA implementation<\/span><\/div><\/div><\/div>\n\n\n\n
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Agreement for Reliance – Approvals recognition<\/span><\/div><\/div><\/div>\n\n\n\n
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WTO – TBT Committee Commitments<\/span><\/div><\/div><\/div>\n\n\n\n
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GRP Legislation<\/span><\/div><\/div><\/div>\n\n\n\n
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Designation of a standards & conformity assessment: executive\/program – Health Regulators<\/span><\/div><\/div><\/div>\n\n\n\n
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Designation of a standards responsible – MedTech Associations<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

2. Technical Regulations<\/h2>\n\n\n\n
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Regulation of SaMD<\/span><\/div><\/div><\/div>\n\n\n\n
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Use of MDSAP \/ In-country Implementation<\/span><\/div><\/div><\/div>\n\n\n\n
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UDI\/GMDN<\/span><\/div><\/div><\/div>\n\n\n\n
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Risk Classification of MDs<\/span><\/div><\/div><\/div>\n\n\n\n
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Labeling: Legal Manufacturer, Country of Origin, Physical Manuf., Storage Temp., Exp. Dates, local re-labeling<\/span><\/div><\/div><\/div>\n\n\n\n
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Electronic Submissions eIFU + eSignatures<\/span><\/div><\/div><\/div>\n\n\n\n
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Medical Device Definition<\/span><\/div><\/div><\/div>\n\n\n\n
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Technovigilance<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

On July 1st<\/sup>, 2020, during the First Virtual Meeting of the Coalition, Principal Members presented their projects.<\/p>\n\n\n\n

The Projects related activities developed by the Technical Secretariat were:<\/p>\n\n\n\n

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Step 1: Grouping of Projects according to priorities<\/span><\/div><\/div><\/div>\n\n\n\n
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Step 2: Identification of common issues<\/span><\/div><\/div><\/div>\n\n\n\n
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Step 3: Discussion with the members<\/span><\/div><\/div><\/div>\n\n\n\n
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Step 4: Implementation<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n

Every action plan was analyzed as to identify whether the cause was:<\/p>\n\n\n\n

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Absence of regulation<\/span><\/div><\/div><\/div>\n\n\n\n
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Country-specific requirements<\/span><\/div><\/div><\/div>\n\n\n\n
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Outdated regulation<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\nAction-Plan<\/a>\n

<\/p>\n\n\n\n

It was identified that the root cause of most regulatory problems experienced by the members begins with conducting inadequate regulatory processes.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n