A new Summit focusing on medical device and technologies regulation, registration, market access and compliance in the Gulf Region will take place this September.
GCC MedTech Summit will bring together regulators, the industry and end users of medical devices and technologies to look at how regulations are taking shape in the GCC.
This year Summit will focus more on Medical devices but some sessions will also cover technologies part.
A number of different approaches to medical device registration and regulation are taken across the GCC. This Summit will provide a platform to discuss how countries can best work towards harmonisation of medical device regulations.
Why focus on GCC medical device regulations?
Regulations for medicines are well established around the globe, with Good Manufacturing Practice (GMP) well understood by health administrations and regulators. However, this is not the case for medical devices, due to the diverse range of products that can be classified as a medical device. Factors such as intended purpose, the technology incorporated in the device and even the presence of pharmaceutical compounds all have to be considered.
With no common application process, those applying for registration or those tasked with ensuring medical device compliance also have to work within a number of different international systems. There is as yet no system across the Gulf for mutual recognition of medical device approval.
In taking steps towards medical device harmonisation in the Gulf Region, stakeholders should consider the potentially huge health and health economy gains that medical device harmonisation can bring. And with it, the opportunity to develop a thriving regional medical devices industry.
This will also mean balancing local priorities with significant external influences. Most notable recently has been the European Union’s major revisions to its own medical devices regulations. Approved in 2017, these come into full effect from May 2020, with in vitro diagnostic medical devices needing to comply by May 2022. In the USA, the Food and Drug Administration (FDA) has seen the 21st Century Cures Act 2016 and Food and Drug Administration Reauthorization Act (FDARA) 2017 come into effect.
What will be discussed?
Over two days, the GCC MedTech Summit will give stakeholders the opportunity to share experiences and learn from each other about what will be required to strengthen and grow the Gulf Region’s medical devices & technologies market.
The programme will feature presentations, round table discussions and interactive question and answer sessions to cover topics including:
- What medical devices regulations are currently in place across GCC countries
- What principles of medical device regulation are being developed regionally
- What is the strategy for developing the regional medical devices industry?
- How is this taking place within the context of the current healthcare reforms?
- How can GCC nations work towards closer harmonisation of medical device regulation and attract medical devices businesses to the region on a sustainable basis?
- The impact of external influences, eg the EU Directives
- A comparative analysis of different regulatory systems for medical devices as used by GCC countries
- The impact of introducing a solid Quality Management System and comprehensive Risk Management to reduce costs and support regulatory compliance
- Stakeholder shared experiences at a country level
- Post-market surveillance and practical implications
- Cyber-security and data risks
- What healthcare professionals want from medical devices
The summit will also run three workshops for regulatory bodies, industry and healthcare professionals:
- Evaluation of medical devices and technical file assessment
- Management, use and disposal of medical devices
- Reporting adverse effects and eliminating counterfeits.
Who should attend?
- Local regulators in the field of pre-and post-market controls
- MedTech industry
- Medical device manufacturers
- Regulatory affairs managers
- Healthcare providers and retailers
- Health professionals with a special interest in medical device use and compliance