Saudi Food & Drug Authority - Medical Devices Marketing Authorisation System
Technologies: IIS, .NET, ASP.NET
Customer Profile
The Saudi Food and Drug Authority (SFDA) is the independent authority, established in 2003 and reporting to the Council of Ministers, responsible for the safety of food and the safety, quality and effectiveness of drugs and medical devices in Saudi Arabia. Its remit covers medical devices, in-vitro diagnostic devices, prescription eyeglasses, contact lenses and their solutions.
Business Situation
A 2007 royal decree gave the SFDA responsibility for regulating medical devices in Saudi Arabia, and the Council of Ministers followed with a decision stressing the importance of regulating devices that relate directly to human health. With the Kingdom's health services growing rapidly, the SFDA needed systems to support this new function: issuing marketing authorisation licences to approved establishments.
The SFDA engaged Engine Solutions to specify the system and assure its implementation.
Solution
Engine Solutions facilitated user requirements workshops where detailed user requirements were discussed and documented. Key workflows were identified which formed the basis of the new system.
Engine Solutions worked with the SFDA to:
- Analyse and document business requirements
- Define and document system requirements specification/functional specification
- Create an implementation plan
- Provide quality assurance of associated implementation project
Results
After this successful engagement the SFDA are now successfully processing marketing authorisation requests from qualifying organisations, as per the requirements of the royal decree.
The MDMA system, as designed, is accessible by SFDA staff, CAB users and manufacturers and authorised representatives, with appropriate security controls in place. KPI dashboards provide summary information to authorised users.
Testimonial
"Engine’s role in our Medical Devices Marketing Authorisation project was pivotal to its success; their total commitment to the quality of the deliverables in this high profile project was crucial to the SFDA, and the project’s success could not have been achieved without their world class professionalism and customer service.
Engine Solutions’ abilities and commitment to the SFDA continually instils an unparalleled level of confidence that they will get the job done within the timeframe and on budget, and this commitment has always made Engine stand out."
Meshal Al-Amri | Executive Director, Premarket Approval & Scientific Evaluation Management
Saudi Food & Drug Authority
www.sfda.gov.sa