Riyadh, Saudi Arabia

info@unifusion-bsc.com

+966557696888

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Saudi Regulatory Consultant
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Navigating SFDA Guidelines

This is our dedicated hub for the latest SFDA Regulatory Guidance.
Here, you can find the most recently released and revised essential guidance from the Saudi Food and Drug Authority, covering Medical Devices, In Vitro Diagnostics (IVDs), Cosmetics, and Pharmaceuticals.

We understand the critical importance of staying current with SFDA regulations for seamless product registration and market access in Saudi Arabia.
This page is designed to be your go-to resource for accurate and timely information, enabling you to navigate the complexities of medical compliance and proactively ensure your products meet all SFDA requirements.

Latest sfda regulatory GUIDANCE

Guidance on Innovative
Medical Devices

Product Classification
Guidance

Guidance on Medical Devices Classification

Inspection fees for Medical Devices Manufacturers

Requirements for Medical Devices
Marketing Authorization


Guidance on MDMA
Significant and Non-Significant Changes

Requirements for
Clinical Trials of Medical Devices


Requirements for Advertisement Approval

Requirements for Post-Market Surveillance of Medical Devices

Guidance on Content of Labeling of Contact Lenses

Requirements of sterile single-use hypodermic syringes

Guidance for Points of Care (POC) Medical Devices Manufacturing

Requirements on Importation and Shipments Clearance of
Medical Devices

Requirements for Unique Device Identification (UDI)

Guidance on the development
of IVDs for in-house use


UniFusion
  • About UniFusion
  • Our Values
  • Why UniFusion
  • Clients
  • News
  • Contact Us
Core Services
  • MDs & IVDs Registration
  • UDI Submission
  • Drugs Registration
  • Cosmetics Registration
  • Product Classification
  • Distribution Solutions
  • Localization Support
  • Expert Consulting
ISO Services
  • ISO 13485
  • ISO 9001
  • ISO 21001
  • ISO 22483
  • ISO 18788
  • IATF 16949
Resources
  • Regulatory Guidance
  • Webinars
  • Newsletter
  • Company Profile

Riyadh, Saudi Arabia

info@unifusion-bsc.com

+966557696888

  • Follow us

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