Medical Devices Regulation
Saudi Food & Drug Authority (SFDA) is about to embark on an Interim Marketing Authorisation Regulation to regulate medical devices market in Saudi Arabia (KSA), (locally manufactured and imported).
The Interim Marketing Authorisation Regulation and its implementing rules will be published soon in the official news paper and on the SFDA website.
THE INTERIM MARKETING AUTHORISATION REGULATION
The Interim Marketing Authorisation Regulation “ is for all medical devices that are intended to be marketed in the KSA. Medical devices may be placed on the Saudi market and/or put into service only if they comply with the applicable provisions of the Interim Regulation.
The Interim Regulation applies to the following parties and products:
A) Manufacturers, authorised representatives, importers and distributors.
B) All Medical Devices and their accessories that will be supplied to the KSA market.
C) Contact lenses and laser surgical equipment for cosmetic rather than medical purposes, and their accessories.
MEDICAL DEVICES NATIONAL REGISTRY
Manufacture established within KSA, international manufacture authorised representatives , importer and distributor are expected to enrol in “Medical Devices National Registry” (MDNR), and list all medical devices that they have in Saudi market before they can apply for “Medical Devices Establishment license” , please be aware that the MDNR is not an approval system.
For more information about the MDNR refer to: http://mdnr.sfda.gov.sa/MDNR/Public/Default.aspx
MEDICAL DEVICES ESTABLISHMENT LICENSING
Local Manufactures involved in distribution activities, importers, distributors and authorised representatives involved in importation or distributors activities shall apply for Medical Devices Establishment License (MDEL)
The SFDA will publish the implementing rules for the “Medical Devices Establishment licensing” and launch the electronic medical devices establishment licensing system.
MEDICAL DEVICES MARKETING AUTHORISATION
Manufacture or its authorised representatives shall obtain a written “Medical Devices Marketing Authorisation” from the SFDA for the medical devices it wishes to place on the market.
The SFDA will publish the implementing rules for the medical devices marketing authorisation and launch the electronic registration system.
p.s. International manufactures are either expected to establish an office in Saudi Arabia or designate an authorised representative.