Summit Schedule

GCC MedTech | Summit Agenda & Schedule

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  • Overview of Medical Devices Regulation in Europe & USA. The new EU regulation: what we can learn from it?
  • Medical devices Cycle: Pre-market, on market and post market surveillance. Specific of the GCC region
  • WHO Guidelines for purchasing. Market access & Pricing

This session will feature representatives of the GCC region’s major regulatory bodies who will speak about their national registration procedure, changes in the regulation and what they will be focusing on in 2020-2021.

Question to discuss:
  • The role of the Government in regulating the market. An overview of current healthcare reforms, new programmes and legislative initiatives to regulate the medical devices sector
  • What is the strategy for developing GCC medical industry?
  • Introducing new principles for regulating the medical devices sector in GCC
  • Strengthening control over the circulation of medical devices
  • Product Bundling
Panel discussion: what we can learn from each other to make our markets stronger and safer?
An overview of the structure and size of the healthcare and medical devices market in GCC, and an analysis of the latest information on the components which make up the market, and the Government’s main actions over the last year
  • What can be done to create sustainable growth, whilst ensuring that it is an attractive proposition for state and private investment, as well as businesses and consumers?
  • Is the GCC market developed enough to attract serious investments into it? How can we support and develop a market that represents the interests of the business community?
  • How can we guarantee market growth in the short-, mid- and long-term?
For this session we will invite GMs of international and local companies to discuss the development, challenges and future of the medical devices industry in the region. The questions include:
  • Timelines of the implementation of new regulations
  • Brexit and the consequences for the GCC region
  • How to coordinate treatment standards with standards for technical equipment
  • Role of Distributors
  • Online registration - game changer?
  • Counterfeit and how industry can support government to fight it
  • Parallel import
We will close day One of the Summit with an interactive session discussion. The audience will be divided into 5 groups. Each group will have a leader – an expert from an authority or Industry, who will moderate the discussion and let the participants share their experience with product registration in GCC and its neighbours
  • Group 1: UAE
  • Group 2: Kuwait
  • Group 3: Oman
  • Group 4: Saudi Arabia
  • Group 5 Bahrain

The European Union’s new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which replaces decades old legislation, requires manufacturers to make significant changes in product development, data reporting and quality assurance.

In the presentation the expert will explain the difference between MDD & MDR; speak about new classification of medical devices and discuss with the audience Industry challenges in meeting of MDR requirements.

There are different classification systems for Medical devices. Each country decide which one to follow but there are always questions related to certain products.

This session will be opened with the comparison analyse of different classifications and followed up by Experts discussion V

Key presentation: GSO – New standards for Medical devices classification.
According to a McKinsey Business Case for Medical Device Quality, Non-routine quality events—such as major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits—cost the industry between $2.5 billion and $5 billion per year on average (Global). This includes $1.5 billion to $3 billion per year on non-routine costs, plus $1 billion to $2 billion in lost sales of new and existing products…
Quality and safety are the key words in healthcare. A solid Quality Management System and a comprehensive Risk Management can reduce costs and support regulatory compliance.

This session will be open buy Key presentations and followed by discussion:

Presentations: Overview of Quality management Systems for Medical devices Risk Management and the ISO standards 14971

The Medical Device Regulation (MDR) is drastically changing the regulatory framework for Medical Devices in Europe. One of the new major challenges is the increased focus on clinical evidence and post-market surveillance (PMS). From now on Medical Devices companies are forced to focus more on safety-related data after MD entered the market. At the same time regulatory bodies and hospitals also have high reasonability to control the safety of devices. This session will focus on
  • Field safety notice impact and recall of devices based on active reporting
  • How to know if the device is falsified and whom to report it to
As an example both below cases will be discussed:
  1. mercury devices
  2. TVT recall

After the session an Interactive Dialog with the Audience will be Accident Reporting as Safety requirement?

The pandemic has showed us how important are innovations, digitalisation, ehealth… but at the same time it highlighted the questions about Patient Safety, Counterfeit, Data protection, Cyber security.. This session will bring experts to discuss this one of the most important topic from different aspects and advise how we can bring innovations and digitalisation in our healthcare, enable electronical records but at the same time to increase security and patient safety

Topics to be discussed:
  • Unique Device Identification (UDI): benefits and needs
  • Interview with Supreme Council on National Medical Records – development and government agenda
  • Cyber Security of medical devices: how to protect the patients? : According Deloitte Survey: Although hospitals are increasingly aware of the importance of good cyber security in their medical devices, improvements are still needed at an operational level. As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks.
We all speak about the venue of innovations and statistics how innovations can improve & safe patients life reduce the healthcare costs, provide better diagnostics and increase lifetime. There are lots of studies that support this information with numbers and case studies. At the same time hospitals and government are facing the question how often you have to update the equipment and what are the real financial advantages. to attend panel discussion we will invite: head of Hospital, head of purchasing department, Professor of economics, Industry representative, financial independent expert.
Room 1
  • for Healthcare professionals and Industry
  • Counterfeit and Reporting
Room 2
  • for Healthcare professionals and Industry
  • Management, Use and Disposal of Medical Devices
Room 3
  • For regulatory bodies
  • Evaluation of Medical devices
  • Technical file assessment
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