About Us

About us

Medical Regulations Gate (MRG)

is one of the leading Medical Device’s consultancy companies with its headquarters in Riyadh, Saudi Arabia working closely with various Regulatory Authorities all over MENA and Asia regions like: Saudi Food and Drug Authority (SFDA), Ministry of Health Egypt (MoH), Ministry of Public Health Lebanon (MoPH), Ministry of Health & Prevention UAE (MoHAP) & Ministry of Health Pakistan (MoH), etc.…

MRG is one of the leading Saudi-managed Regulatory Affairs consultancy and licensing firms in the Kingdom representing over 30+ top graded national companies and 300+ medical devices manufacturers worldwide. MRG provides optimum consultation services for Saudi authorities such as MOH, SGH, SAGIH and SASO.

MRG is always pleased to be part of your success by assisting your business process in a high-level of Commitment through guiding and advising manufacturers on all the requirements pertaining to PRE and post-marketing requirements regarding all issues concerning medical devices, in-vitro diagnostic devices, contact lenses, laser surgical equipment and healthcare all over MENA and Asia regions.

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.

Quality Policy Statement

 

The basic orientation of Medical Regulations Gate is to be recognized for quality in improving our commitment to deliver to our customers by providing quality consultation services for regulatory compliance. In support of our vision, the policy is to maintain a practical but comprehensive quality management system based on ISO 9001:2015. This will be central to the delivery of our commitment to customer satisfaction and continuous improvement.

We have established following systems/ procedures to support achievement of this policy:

  • Commitment from and involvement of Top Management to customer satisfaction and continuous improvement.
  • Responding promptly and accurately to customer enquiries and requests along with regular collection and monitoring of customer feedback.
  • Setting measurable quality objectives and setting defined responsibilities for their fulfillment.
  • Pursuing statutory and standard requirements.
  • Employee engagement at all levels of the organization along with their training and development initiatives.
  • Regular internal audit of our processes to check deviances from standards and management’s actions to address/ manage them.
  • Risk assessment and management.