Medical Devices Services

Now Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. There is a big attention is paid by Saudi Arabia for international Medical Device Manufacturers planning to access new markets.

Global Trans Solutions is up to the level to ease the whole process from A to Z and making sure that all procedures have been done on the perfect way, we offer our customer:

  • Creating MDNR Account

  • Adding Factory to MDNR

  • Adding the medical devices to MDNR

  • Medical Devices Establishment Licenses (MDEL) application

  • Medical Devices Establishment Licenses (MDEL) Renewal

GTS is an Authorized Representative and Medical Devices Regulatory Service provider in Saudi Arabia operated by a highly experienced team specializing in SFDA regulations & Systems.  Authorized Representative will:

  • Submit the Authorized Representation registrations with the Saudi FDA.

  • Administrate the Authorized Representative registration fees.

  • Submit your MDMA application (Medical Device Marketing Authorization) with the SFDA.

  • Administer MDMA application (Medical Device Marketing Authorization) fees.

  • Notify the SFDA of any Changes to the product(s).

  • Assist in adverse event reporting to the SFDA, in close liaison with you and distributors.

  • Assist in Device Field Safety Corrective Actions (recalls).

  • Assist in providing marketing/advertising materials to the SFDA for approval.

  • Be available at all times to interact between the manufacturer and the SFDA.

If you plan to market Medical Electrical Equipment, GTS offer its Medical Equipment Maintenance team with clinical engineering experience and equipped with biomedical testing equipment and workshops that fulfill the requirements of the SFDA and the CBAHI Standards GTS make it easy for you to participate in tenders and take of the burden of managing maintenance after placing the Equipment in the client premises.