Medical Regulations Gate - Medical Devices regulations

Egypt Medical Device Registration

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The Right Partner for Your
Regulatory Compliance Needs

Without consulting, plans stay as plans.

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Are you ready for SFDA's New Technical File Requirement?

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The Right Partner for Your
Regulatory Compliance Needs

Without consulting, plans stay as plans.

View services

Need assistance complying with Medical Devices regulations in the Market?

Medical regulations Gate (MRG) is the best choice for helping you gain access to the Market in MENA Region with superlative Regulatory Affairs Expertise.

MRG is a group of consultancy companies that provide Medical Device Manufacturers with the Regulatory support needed to ensure a high level of accessibility in MENA region.
As one of the leading Regulatory Affairs consultancy and licensing firms, MRG is representing over 400 medical device manufacturers worldwide.
Working closely with various Regulatory Authorities all over MENA region like: Saudi Food and Drug Authority (SFDA), Egyptian Drug Authority (EDA), Ministry of Health & Prevention UAE (MoHAP) & Turkish Medicines and Medical Devices Agency (TITCK),etc.…

OUR SERVICES

Services in UAE

We help Medical Devices Manufacturers and Importers/ Distributors with Health Authorities in UAE

Services in KSA

We ensure our clients comply with KSA and Saudi Food and Drug Authority (SFDA) regulations

Services in Egypt

We ensure our clients comply with the Egyptian Regulations as well as Egyptian Drug Authority (EDA)

Services in Turkey

We position our clients at the forefront of their field by advancing an agenda.

With 20+ years of experience and extensive knowledge of KSA medical devices market and regulations, Medical Regulations Gate has registered 100,000+ medical devices with the SFDA, covering medical devices of all classifications and various jurisdictions.

Business Growth

Whatever the scenario, we tap into deep networks and innate understanding of each party’s priorities.

Security

A continuous commitment to guaranteeing a secure environment in which customers can realise their ideas to the highest standard, trusting in MRG as a valued…

Initiative

MRG promotes a spirit of initiative to find high-performance solutions. Driven by creativity to create value for and with its customers, making the right decisions…

Highly Qualified Team

experts that are associated with deep and solid level of professionalism to ensure the compliance of your medical devices with the Market’s Regulations

Our Vision

To lead the market by ensuring that our clients are provided with the best consultation services to meet the regulatory compliance challenges and requirements for Medical devices, Cosmetics, health care and drug products in MENA and ASIA Region.

Our Mission

As an experienced Regulatory Affairs Consultation company in MENA and ASIA Region, we offer precise regulatory Compliance solutions in Medical Device, Cosmetics, Health Care and Drug – Registration field, by fulfilling our client’s expectations through assisting and guiding them in every stage of their product registration, making sure they reach their targeted markets successfully.

To review means to look back over something for evaluation or memory.

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It is always a joy to hear that the work we do has positively impacted our clients and that they are happy to share their feedback.

You can learn more from our asked questions

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Ronald Dumple

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Ronald Dumple

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Ronald Dumple

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In the Middle East

Medical Regulations Gate (MRG) is committed to guaranteeing the best services in which our customers can achieve their goals with highest standard possible, relying on MRG as an indispensable partner to unleash their full potential.