MEA MedTech regulations

MEDICAL TECHNOLOGY
REGULATIONS IN MEA

The world is changing rapidly,
and as industries evolve,
so do regulations.

Medical Technology Regulations in MEA

Staying up-to-date with health authorities moving from open market to a regulated environment.

Since the inception of Mecomed as a trade association, we have worked hand in hand with the regulatory bodies in the region to ensure the right regulatory framework is in place, in alignment with international standards and best practices, as this would serve Mecomed's mission to enable access to the latest and safest medical technology to the patient in the MEA region.

As we are witnessing more and more health authorities moving from open market to a regulated environment, we always encourage:

1

Appropriate Regulation

Setting appropriate regulation by leveraging international standards, mainly IMDRF documentation, relying on EU Directives and the upcoming EU Regulations, US FDA PMA and 510K and other reference countries like Japan, Australia, etc … and adapt these as needed to meet the local setup and requirements.

2

Engagement of Industry

The value of engagement of industry at the early stages for any introduction of a new regulation or a change in the regulation, by relying on the expertise of companies and having them comment on draft regulation.

3

Negotiation and Discussion

Continuous negotiation and discussion to address any potential challenges in the implementation process, ensure proper notice and transition timelines, the availability of guidance documents and clear information.

The world is changing rapidly

As industries evolve, so do the mechanisms that regulate them. Hence the importance for Regulators to be responsive and flexible to new conditions to improve regulatory regimes, help industries to respond, and motivate companies to innovate, while keeping the patient first.

Capacity Building initiatives is at the core of our objectives at Mecomed and is exceptionally important as it values the expertise trade association and industry can bring on international regulatory trends and developments to ensure the region is at par with the changes happening on global level.

Mecomed being a member of GMTA (Global Medical Technology Alliance) works closely with international associations in Europe, US, Asia and Africa, and having on board global manufacturers across all medical technology ranging from Medical Devices, IVDs, and Imaging, leverages the expertise of the industry, as well as international and regional experts, to support with state of the art trainings and capacity building opportunities, shoring up sustainability, improving governance and oversight, supporting collaboration, and strengthening infrastructure and knowledge.

A common goal

We all share a common goal that is to instil ethical business practices and compliant behavior across the different MedTech Stakeholders. On the regulatory forefront, reinforcing the skills, resources, and develop abilities that allow the Trade Association who is the Voice of the Industry and the regulatory bodies to grow and thrive for continuous improvement in a constantly changing environment that is the medical technology, in helping shape the regulations by always keeping the patient safety at the center of everything we do and engage in.

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