The Leading Name in Consultancy We help clients by providing the best consultation services to meet the regulatory compliance challenges and requirements for Medical devices, cosmetics, health care and drug products

ABOUT US MRG is a leading Medical Devices consultancy company with its headquarters in Riyadh, Saudi Arabia 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.… MRG is honored to cooperate with over 400 successful Healthcare Organizations that include; Medical Devices/ IVD Manufacturers, Medical Devices/ IVD Distributors & Hospitals. MRG proudly continues to lead its markets by working alongside our clients as one team with a mutual ambition to accomplish extraordinary results in regulatory compliance. We are always pleased to be part of your success, by assisting you to simplify your business process with a high-level of Commitment by guiding and advising you on all the pre and post-marketing requirements for medical devices, in-vitro diagnostic devices, contact lenses, and laser surgical equipment in MENA region.

Bridge To Your Sucess

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

OUR SERVICES KSA With 20+ Years of experience and extensive knowledge of medical devices and Pharmaceutical markets and regulations, MRG has successfully registered 200,000++ medical products covering all classification and various jurisdictions. For Manufacturers For Medical: • • • • • •

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Reviewing and submitting the AR Agreement to SFDA. Consultation about the Medical Devices registrations with Saudi FDA. Communicating with the manufacturers regulatory affairs team to help them with the TFA requirements preparation. Revision of the TF ‘’Technical File’’ documentation and providing feedback when necessary. Submitting TFA applications to Saudi FDA to obtain the MDMA certificate approval. Communicating with SFDA on an elevated level to discuss any issues related to submitted Technical File, to reach the best possible solutions to obtain the products approval. Communicating with SFDA for any Clarification, Request or Inquiry needed from the manufacturer side related to product registration process. Submitting renewal requests for any expired MDMA certificate for manufacturers. Updating any valid MDMA certificate for the manufacturers. Post Market follow up services for Recalls/FSCA/Adverse Events, and submission of reports to the National Centre for Medical Device Reporting ‘’NCMDR’’. Submitting classification requests to the classification department at SFDA for them to decide whether the product falls under the SFDA supervision or not. Transferring MDMA certificates from other ARs to MRG account, when requested by the manufacturer. Applying for Medical Devices Advertising approval Submission of UDI information in the Saudi-DI database for all the products that have MDMA approval.

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

OUR SERVICES KSA For Manufactures for Pharmaceutical: • • • • • •

Provide support with regulatory submissions (module 1 file preparation), gap assessment of the existing CTD dossier and answering SFDA deficiency queries Setting up the regulatory strategy securing market access for new drugs and supporting variations and renewals Providing the most updated regulations, guidelines and circulars and sending the updates as soon as issued. Follow up on variations, renewals, pricing, reimbursement & pharmacovigilance. Prepare for GMP Inspections. Engage in the pricing of new products taking into consideration the current regulations.

For Local companies: • • • • • • •

Obtaining Medical Device Establishment License (MDEL) Preparing SOPs ‘’Standard Operating Procedures’’ for submission of Medical Device Establishment License (MDEL) Applying for Medical Device Importation License (MDIL) Applying for warehouse certificate with SFDA Working on behalf of local companies to help them with SFDA product registration under their account. Submitting renewal requests for any expired MDMA certificate. Updating any valid MDMA certificate.

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

OUR SERVICES EGYPT MRG.Egpyt is an independent medical device consulting company, approved by the Egyptian Drug Authority (EDA) to act as an “Authorized Representative” on behalf of the medical device Manufacturers. MRG can provide the required regulatory support to deal with the Egyptian Drug Authority (EDA). • • • • • • •

Assemble and submit the product registration file to EDA Submit documentation to the scientific committee for review, if needed Notifying EDA of any changes / variations in the product or any information about the manufacturer Assisting manufacturer with their post marketing and vigilance Assist with preparing responses to additional information requests from EDA Transferring registration to another importer Shipment release requests

UNITED ARAB EMIRATES MRG. AE is consulting company to help Medical Device Manufacturers, Importers/Distributors and Regulatory Bodies in order to comply with the current regulations set by Ministry of Health and Prevention in Dubai (MOHAP) • • • •

Submitting Product registration with the ministry of health (MOH) Listing of product with the health authority – Abu Dhabi (HAAD) Listing products with Dubai Health Authority (DHA) Registering all medical products, as well as fulfilling all the post-marketing requirements of Emirates standardization & Metrology for Authority (ESMA)

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

OUR SERVICES TURKEY MRG TURKEY is a licensed company by the Turkish Health Authority to register products belonging to overseas and local manufacturers under its account, MRG can provide the required regulatory support to deal with the Turkish Medicines and Medical Devices Agency (TMMDA/TİTCK).

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Reviewing and submitting documents for the provincial health department for UTS (Product Tracking System). Company registration in UTS and EBS-ESY (Electronic Application and Process Management System). Taking part between manufacturer and TITCK (Turkish Medicines and Medical Devices Agency). Medical Device document, product registration to UTS. Taking part in the translation of documents required during UTS registrations. Document and label control in accordance with TITCK requirements. Notifying TITCK of any changes in the product or information about the manufacturer. Assisting manufacturers with notification of vigilance. To follow the announcements made from UTS and TITCK’s website and if it is related to the manufacturer’s products, to inform the manufacturer and to take the necessary action with the manufacturer’s approval. Providing consultation services for overseas manufacturers, local manufacturers, and importers regarding Medical Devices regulations in Turkey. Application for importing and sending the samples to HA laboratories for the IVD Products.

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

SOME OF MRG'S INTERNATIONAL CLIENTS

EMAIL : [email protected]

PHONE : +966 11 2934961

WEBSITE : https://mr-gate.com

Bridge To Your Sucess