The GHA-German Health Alliance is a strategic partner of the second GCC MedTech Summit 2021. The event will be looking at medical device and technologies regulation and will take place from September 20-22.

The GCC MedTech Summit is an important event for anyone involved with providing or using medical technology and especially medical devices, in the Gulf region – industry, regulators and end users.

The 2020 event looked at the development of the GCC medical devices market at a country and regional level and the challenges and opportunities shaping the uptake of medical technology. The event also set out how medical device regulations around device classification are being developed internationally as well as the practical aspects of product quality and safety – from prelaunch through to market and post-launch surveillance.

The 2021 event will develop these themes, reviewing the development of regulations and policies in the Gulf region around medical device regulation, and how that has been influenced by other regions and events.

Important topics:

Over three the course of three successive afternoons, the rich and detailed programme will feature presentations, roundtable discussions and interactive question and answer sessions covering topics such as:

• Development of the GCC medical devices market with country-specific updates
• Global health initiatives impacting on medical device regulation and deployment
• Lessons from responding to Covid
• Steps taken towards harmonisation of regulation and compliance
• Digitisation, cyber security and data risks, including software as a medical device
• A global quality management system approach and the Medical Device Single Audit Program (MDSAP)
• Comprehensive risk management in relation to medical devices
• Post-market surveillance and vigilance
• Medical devices as a business – what role, if any, for pricing regulations?
• he impact of the European Union’s medical devices regulations including in vitro diagnostics
• Implementing Unique Device Identification (UDI), counterfeit products, parallel importing and compliance
• Medium and long-term ambitions for medical technology in the context of ongoing healthcare reforms
• Case studies and success stories: stakeholder shared experiences at a country and regional level
• Responding to health professionals’ expectations and requirements around medical technology
• Biocompatibility for medical devicesPlanned workshop sessions will focus

Planned workshop sessions will focus on:

• Market access for industry
• Understanding the medical device lifecycle and its impact on health professionals as end-users
• Evaluating the medical devices technical file assessment for regulators

GHA-Members can attend for a reduced fee. Please contact our office in Berlin: erbacher@gha.health.