Cairo Calls for Change: MedDevReg AfriSummit Insights

Welcome to this exciting edition of Easy Medical Device NEWS! ?? This week, we’re turning the spotlight on the MedDevReg AfriSummit held in Cairo, Egypt—a transformative event that’s driving the future of healthcare regulation in Africa. ????

From innovative solutions to pressing challenges, the summit brought together top experts, regulators, and industry leaders from across the continent to discuss how Africa can strengthen its healthcare systems through harmonized regulatory frameworks and improved compliance. ????

An Overview of Impactful Topics Featured at MedDevReg AfriSummit

The PharmaReg AfriSummit 2024 focused on several critical aspects of medical device regulation, offering insights into the evolving regulatory landscape in Africa. The MedDevReg track covered key topics that are shaping the future of medical device compliance and healthcare delivery across the continent. Here are some of the prominent themes discussed:

1. Medical Device Regulations Classification ?? The classification of medical devices plays a crucial role in determining the regulatory pathway a device must follow. Discussions revolved around the different categories of medical devices and how classification systems impact safety standards, market access, and regulatory oversight.
2. Medical Device Regulations Status in Africa ?? As Africa continues to develop its healthcare infrastructure, medical device regulations are evolving at different paces across countries. Experts examined the status of regulatory frameworks in key African nations, highlighting challenges and progress in aligning with international standards.
3. Regulatory Updates from Specific Countries ?? The summit provided in-depth updates on the regulatory status in specific African countries. Delegates discussed the latest changes to medical device regulations, including new requirements for market access, registration, and post-market surveillance in various regions.
4. Reliance of Distribution and Supply Chain Regulations ?? Effective distribution and supply chain management are essential for ensuring the timely delivery of medical devices. Sessions focused on how African countries can streamline regulatory requirements for device distribution, overcoming logistical challenges and ensuring compliance across borders.
5. Labeling Requirements ??? Labeling is an essential part of ensuring that medical devices are used safely and effectively. The summit addressed the regulatory requirements for device labeling, ensuring compliance with regional standards and facilitating better communication between manufacturers and healthcare providers.
6. The Role of AI in Medical Devices – Preparing for the Future ?? With the rise of artificial intelligence (AI), there was a significant focus on its application in medical devices. Experts discussed how AI is transforming device functionality and regulatory compliance, as well as how regulatory bodies are preparing for AI-driven innovations in the medical device industry.
7. Quality Management Systems – Evaluation and Manufacturing in Africa ?? The summit highlighted the importance of robust Quality Management Systems (QMS) in ensuring the safety and effectiveness of medical devices. Discussions centered on QMS requirements for manufacturing in Africa, emphasizing the need for continuous improvement and regulatory alignment with global standards.
8. Evolution of Pharmacovigilance in Africa ?? As African healthcare systems mature, the evolution of pharmacovigilance (the monitoring of medical device safety) has become a key topic. Sessions covered the challenges and opportunities of implementing pharmacovigilance frameworks, with a focus on enhancing post-market surveillance and ensuring patient safety across the continent.

The summit provided a comprehensive platform for discussing the future of medical device regulation in Africa, with a particular focus on developing regulatory capacities, ensuring safety, and fostering innovation. It was an invaluable opportunity for professionals to share knowledge and shape the future of healthcare regulation on the continent.

For further details, you can view the full MedDevReg agenda or the agenda PDF.

?? Updated EU IVDR Consolidated Text Released! ??

The European Commission has published the latest consolidated version of Regulation (EU) 2017/746 for in vitro diagnostic medical devices, incorporating key amendments and corrections, including Regulations (EU) 2022/112, 2023/503, 2023/607, and 2024/1860.

?? ????????: This consolidated text does not yet include Article 10a, which will come into effect on January 10, 2025, as per Regulation 2024/1860. Therefore, while many updates are reflected, it is not fully consolidated. This also applies to the MDR.

For professionals in diagnostics and regulatory affairs, reviewing these updates is essential to stay current with IVDR requirements.

?? Read the updated text here

Highlights from Afrisummit 2024! ???

The PharmaReg AfriSummit 2024 in Cairo wrapped up with some truly impactful discussions.

Noha El Hariri presented the Egyptian Drug Authority's Reliance activities, offering valuable insights into Egypt's evolving regulatory landscape. ????

We were also thrilled to have Monir El Azzouzi Monir was our Special Reporter, who provided live updates and shared key takeaways from the summit sessions. ??

Stay tuned for more highlights from the event, as we bring you all the key insights! ??

?? Mastering Internal Audits in Medical Device QMS! ??

Are you ready to elevate your internal audit processes? Whether you're aiming to comply with ISO 13485 or improve your quality management, this guide is essential reading! ??Check out Easy Medical Device's article on how to set up, conduct, and make the most of internal audits for medical devices. From planning to reporting, it’s packed with actionable tips to help ensure compliance and continuous improvement.

Read the full article here ?? Link

Challenges of Reliance in Medical Device Regulations ????

The first panel discussion at MedDevReg AfriSummit 2024 tackled the key challenges of Reliance in medical device regulations.

Panelists included:

• Christopher Odero, PhD
• Noha El Hariri
• Nancy Ngum
• Khanyisile Nkuku
• Shellan Omondi

The panel highlighted several key challenges:

• Political Differences between countries
• Trust Issues between regulatory bodies
• Lack of Resources or Inadequate Training
• Timelines and Accountability

Despite these challenges, countries are making progress year by year, slowly overcoming these barriers and moving toward more efficient regulatory practices. The dedication shown by these countries is commendable, and we look forward to seeing more strides toward collaboration and harmonization.

AFRISUMMIT 2024 Panel Discussion: EU MDR Timeline Impact ????

At AFRISUMMIT 2024, the Egyptian Drug Authority (EDA) shared valuable insights into the challenges they faced due to the upcoming EU MDR deadline of 26 May 2024.

In this panel discussion moderated by Rana Chalhoub , Miriam Boles highlighted the struggles the EDA encountered while trying to align with the stringent requirements of the EU Medical Device Regulation (MDR). The conversation also featured insights from shaimaa salah , Dario Belluomini , and Asmaa Awad , who contributed their perspectives on regulatory challenges and solutions within the medical device sector.

The panel provided an eye-opening view of the hurdles regulators face when adapting to the fast-approaching EU MDR timeline, underlining the urgency for all stakeholders to prepare ahead of the deadline. ?

How MDR and IVDR code can save you money?

We are sure you will like this episode where Stefan Bolleininger from @BeOnQuality will explain to you how to save some money on your MDR or IVDR submission just by following a logic. So select the right MDR or IVDR code and also the Right EMDN code.

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MedDevReg AfriSummit 2024 Day 1: Session Highlights ????

Session 4: East Africa Medical Device Updates

Day 1 of MedDevReg AfriSummit 2024 featured an insightful session on the latest medical device regulatory updates across East Africa.

Moderator:

• Dr. Dalia Safwat , Quality Assurance Manager for Africa & ME at Alcon

Speakers:

• Dr. Lamiaa Attia , Manager of the Medical Devices Vigilance Unit at the Egyptian Drug Authority (EDA)
• Mr. Monir El Azzouzi , CEO & Founder of Easy Medical Device

During this session, experts shared critical updates and insights into regulatory processes, challenges, and opportunities within the East African medical device landscape. Discussions centered around strengthening vigilance systems and adapting to changing regulations to ensure the safety and efficacy of medical devices across the region.

Stay tuned for more updates! ??

Afrisummit 2024: Moroccan Medical Device Regulatory Update ??????

At Afrisummit 2024, Saadia Abatour from the Moroccan DMP (Directorate of Medicines and Pharmacy) provided a comprehensive review of the Moroccan Medical Device Regulatory Update.

Her presentation covered the latest regulatory developments in Morocco, offering valuable insights into how the country is aligning with international standards while addressing local challenges.

This update highlighted Morocco's growing focus on improving medical device registration, post-market surveillance, and overall compliance to ensure the safety and effectiveness of medical devices in the market.

Stay tuned for more insights from the summit! ??

When “minor changes” become a major project! ????

Ever feel like your ‘quick fixes’ turn into a whole new quest? Navigating the regulatory maze sometimes feels like trying to find your way out of a never-ending scroll of paperwork! Who else has been there? Share your tales of ‘minor adjustments’ below!

Afrisummit 2024: The Benefits of MDSAP for Industry and Authorities ????

At Afrisummit 2024, Marie Bouchra from Johnson & Johnson delivered an insightful presentation on the benefits of adopting the Medical Device Single Audit Program (MDSAP) for both the medical device industry and regulatory authorities.

She highlighted how MDSAP simplifies the process for manufacturers by allowing a single audit to satisfy the requirements of multiple countries, making it a cost-effective and efficient solution. For regulatory authorities, the program ensures that medical devices meet international safety and quality standards, streamlining oversight and promoting greater global harmonization in medical device regulation.

Stay tuned for more highlights from the summit! ??

Afrisummit 2024: Tackling Counterfeit Products in Africa ????

The final panel of Afrisummit 2024 focused on the growing challenge of counterfeit products in Africa.

Moderator:

• Brian Savoie, Regulatory Affairs Professionals Society (RAPS)

Panelists:

• G?rkem AYDIN, VISIOTT Traceable Packaging Solutions
• Noha El Hariri, Egyptian Drug Authority

The discussion explored the serious implications of counterfeit medical products in Africa, including their impact on patient safety and regulatory compliance. The panelists emphasized the need for advanced traceability solutions and stronger cross-border collaboration to combat this issue. They also highlighted innovative approaches, like VISIOTT’s traceable packaging solutions, which aim to increase product authentication and secure supply chains.

Stay tuned for more updates from Afrisummit 2024! ??

?? Missed the AI ACT Summit? Now’s your chance to catch up on all the insights! ??

Our????? ?????? ???????????? ???????????? is now live! Access expert discussions on navigating AI regulations, overcoming emerging challenges, and shaping the future of AI in medical devices and beyond. This is your unique opportunity to learn from top industry leaders and innovators. ????

Don't miss out on this chance to stay at the forefront of AI innovation and compliance!

?? Access the replay for free here and get ahead in AI innovation and compliance! But hurry – it’s only available until February 2024

?? Share with colleagues and friends who want to stay ahead in AI and medical device compliance.

Wrapping Up: Key Takeaways from MedDevReg AfriSummit 2024 & Regulatory Updates ????

This edition of Easy Medical Device NEWS has been packed with exciting insights from the MedDevReg AfriSummit 2024 and crucial regulatory updates, including the latest EU IVDR consolidated text. As we move forward, the importance of harmonized regulations, innovation, and quality management in Africa's medical device landscape cannot be overstated.

The discussions at the summit have emphasized the ongoing efforts to address regulatory challenges, with AI and robust QMS frameworks playing pivotal roles in shaping the future of healthcare across the continent.

Stay tuned for future editions where we will continue to bring you the latest industry trends and regulatory developments that drive our shared mission of advancing global healthcare standards. Together, let's continue to innovate, collaborate, and push the boundaries of what’s possible! ????

Thank you for being part of this journey!

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