Certificates

ALSHIFA has achieved the following certification

• ISO System Certification
  ISO 13782 for Medical Devices
  Notified Body – SGS, UKAS
• Medical Device Registration with U.S. FDA – 9680597
• 510(k) Premarket Notification : K972452 – RAMY Piston Syringes
• 510(k) Premarket Notification : K971664 – RAMY Integrated Insulin Syringes
• GMP – Good Manufacturing Practice Certified by SASO (Saudi Arabian Standards Organization).
• WHO (PQS) – Prequalification System for Immunization fixed dose syringes