Friday, 10 November 2023 / Published in White Paper
FOREWORD BY MECOMED In the Middle East and Africa (MEA) region, the implementation of health technology assessment (HTA) is in its nascent stages. Among countries in the region, there are differing levels of understanding of how health technologies should be evaluated, while guidelines on the HTA of medical devices, including in-vitro diagnostics(IVDs), are largely absent.
Friday, 10 November 2023 / Published in White Paper
Abstract The healthcare landscape is undergoing a revolutionary transformation, thanks to the advent of the Digital Health Ecosystem. This interconnected landscape of multiple stakeholders is reshaping the way healthcare service providers approach healthcare delivery and patient care. This white paper explores the various components of the Digital Health Ecosystem, as seen from the Mecomed perspective,
Press Release
Monday, 30 October 2023 / Published in Press Release
Mecomed’s participation at the Saudi Global Health Exhibition showcases the convergence of MedTech innovation and sustainable healthcare, indicating a transformative era ahead. 30th October 2023, Riyadh, Saudi Arabia – Mecomed, a Medical Technology Association in the Middle East and Africa, is set to play a pivotal role at the upcoming Saudi Global Health Exhibition in
Thursday, 14 September 2023 / Published in White Paper
Background: As of January 2, 2024, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will be transitioning from paper export documents for medical devices to electronic export documents, as per a recent letter communicated to the industry on July 10. The Documents to be issued electronically include: Certificate to
Fortifying the healthcare sector in the Middle East & Africa region through the power of AI
Tuesday, 15 August 2023 / Published in Blog Post
By Inna Nadelwais, Executive Director, Mecomed The healthcare sector is at the heart of the region’s growth and its development is imperative for ensuring healthier communities. In the Middle East and Africa, the sector faces several unique challenges, including a rapidly growing population, shortage of healthcare professionals, and a high burden of communicable and non-communicable
Integrating ESG into our Industry
Wednesday, 09 August 2023 / Published in Blog Post
By: Rami Rajab, Chairman of MECOMED, Middle East and Africa Trade Association for Medical Devices, Diagnostics and Imaging Introduction: In an era marked by a growing emphasis on sustainability and responsible business practices, the principles of Environmental, Social, and Governance (ESG) have become central to the success and reputation of various industries. Within the medical
Mecomed Paper on UDI Recommendations
Friday, 19 May 2023 / Published in White Paper
We strongly encourage health authorities implementing (UDI) regulations to harmonize their UDI requirements in line with the (IMDRF) UDI guidance*. This will ensure global harmonization and facilitate compliance across the medical device and IVDs industry, when it comes to leveraging: an internationally accepted UDI coding system (e.g., GS1, HIBCC, or ICCBBA), IMDRF UDI labeling recommendations,
Wednesday, 10 May 2023 / Published in White Paper
On 6 January 2023, the European Commission proposed a Regulation to amend the transitional provisions of the Medical Devices Regulation (MDR – (EU) 2017/745) and the in-vitro Diagnostic Medical Devices Regulation (IVDR – (EU) 2017/746). On 16th February and March 7th respectively, the European Parliament and the Council of the European Union officially adopted the
Wednesday, 18 January 2023 / Published in Blog Post
Carol Attieh, Chair of Mecomed’s Regulatory Committee and Senior Manager, GEM Regulatory Lead at Boston Scientific The Middle East and North Africa (MENA) region is still considered a growth opportunity despite its political and economic instability for many multinational manufacturers of Medical Devices and IVD’s due to its unique mix of countries. One of the
HTA For Medical Devices
Tuesday, 10 January 2023 / Published in Blog Post
Dr Tienie Stander, Managing Director, VI Research FZ LLC Dr Inna Nadelwais, Executive Director, MECOMED Mecomed is actively engaging in building MEA region’s capacity building and advancing the devices HTA knowledge base at all stakeholder levels. This will pave the way for constructive partnerships between HTA agencies and industry. Below is the abstract of the