Medical Device Regulatory Convergence Project (MDRC) – Africa Medical Devices Forum (AMDF) / FDA Workshop Agenda 

The Medical Device Regulatory Convergence (MDRC) Project in collaboration with the African Medical Device Forum and the US Food and Drug Administration, prepared a program that was delivered in a hybrid format in Nairobi, Kenya from 6 to 09 November.

This workshop will provide an exchange of information and capacity building between the AMDF, its member NRAs and partner reference NRAs including the USFDA, TGA, HSA, ANVISA, also the Africa CDC and industry covering the core international references for medical device regulatory frameworks including the following core topics: IMDRF, international standards including ISO 13485 and ISO 14971, conformity assessment, MDSAP, Post-Market Activities, Good Reliance Practices, Proper Legal Foundations for Rulemaking including Good Regulatory Practices (GRP) and Technical Barriers to Trade (TBT), USFDA Regulation of Medical Devices, Reference NRA experiences, and other related topics. The workshop objective is to support and advance the AMDF 2023 Workplan and Training Plan in furtherance of the AMDF 5-year strategic plan accelerating African MD NRA capacities, to support the AMDF application as a Regional Harmonization Initiative (RHI) of the IMDRF, to strengthen the soft infrastructure of medical device regulatory frameworks on the continent to incorporate global lessons learned from the COVID-19 pandemic, to better prepare for future health emergencies, to prevent the implementation of unnecessary regulatory barriers to medical technologies, to improve general MD NRA public administration and general public health. The workshop will also support acceleration of diagnostics access in Africa in collaboration with the Africa CDC support to AMDF medical device work through the Diagnostic Advisory Committee (DAC).

The event will be delivered in a hybrid format for which either in-person or virtual participation is welcomed by registering here by 30 October.

Agenda

Day 1 (11/06)

Recording

Presentations

Goals for the week – Sandra Ligia – MDRC

Overview of FDA Regulation of Medical Devices FDA 101 – Michelle Noonan – USFDA-CDRH

IMDRF and international harmonization – Michelle Noonan – USFDA-CDRH

ISO 13485 and 14971 What is 14971 and how is it incorporated into 13485 how is it used in standards – Scott Colburn – USFDA-CDRH

ISO 13485 – Melissa Torres – OCD CDRH-USFDA

Day 2 (11/07)

Recording

Day 3 (11/08)

Recording

Presentations

MDSAP overview Audit Report – Certificate Audit Approach Assessment Program State Of The Program – Neil Mafnas – USFDA-CDRH

Overview of MDSAP Audit Report – Certificate – Linda Moon – Ajith John – BSI

MDSAP Assessment Program – Linda Moon – Ajith John – BSI

MDSAP Audit Approach – Amy Nelson – Roche Diagnostics

MDSAP Audit Approach – Linda Moon – Ajith John – BSI

MDSAP Audit Assessment – Amy Nelson – Roche Diagnostics

Postmarket Activities – Michelle Noonan – USFDA

Post Market Activities – Tammy Steuerwald – Roche Diagnostics

Day 4 (11/09)

Recording

Presentations

Good Reliance Practices – Tracey Duffy – TGA

Good Reliance Practices – Rama Sethuraman – HSA

Good Regulatory Practices A Regulator’s Perspective – Kristan Callahan – USFDA

WTO TBT Agreement and What it means for HRAs – Kristan Callahan – USFD

IVDs DACs Overview – Noah T. Fongwen – Africa-CDC

Elevating Diagnostic Accessibility – Asmaa Awad – EEMEA and Roche Diagnostics

Good Reliance Practices – Augusto Geyer – ANVISA