Announcement made by Saudi Arabia SFDA in August hits the local registrants. In-country representatives as SFDA are closing all the current medical devices registration systems and replace them with a Unified Electronic System (GHAD).
Ghad allows an unified registration platform on the Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi Authorized Representative and other applications to SFDA.
SFDA advised that registered establishments to register and open a new account on the Ghad System, starting from 10 November 2019. All the existing and pending applications in the old system will have to be transferred to Ghad by the applicant. Applicant action is important to ensure that they maintain copies of the current applications and documents from the old SFDA system before all these old systems closed, before 26 December 2019.
SFDA Technical Files & Saudi Arabia regulation
More technical files will be required from the manufacturers to provide evidence of compliance to a certain route.
The manufacturer needs to provide the following:
The Technical File document in which the intended use and clinical benefits are stated to each device.
Post-Market Surveillance (PMS) plan and report for each device.
Risk management report and plan
Classification and compliance check list.
Clinical evaluation report
Post marketing clinical follow up
Click here for the new regulations (MDS-G5).
SFDA product approval validity and fee
The expiry date of the product approvals used to depend on the expiry of the manufacturer certificates and maximum of 3 years. However, the new system will issue an approval for 3 years consistently, and fees for review will depend on the number of items in the application.
Click here for the new fees by SFDA (SFDA-MD36466).