I will sfda compliance consulting expert

SFDA (Saudi Food & Drug Authority) regulates medical devices in Saudi Arabia. To market your device, you need SFDA approval, which requires specific regulatory documentation like a Technical File, Risk Management, and Post-Market Surveillance (PMS) Plan.

SFDA requires key documents such as: ✔ Technical File (SFDA Format) ✔ Risk Management File (ISO 14971) ✔ Post-Market Surveillance (PMS) Plan ✔ Biological & Clinical Evaluation Reports (BERS & CERS) ✔ Electronic Common Technical Document (eCTD) Formatting

Yes! I assist in preparing and organizing the required documentation for MDMA submission, ensuring compliance with SFDA regulations.

I focus on regulatory documentation needed for submission. However, I can guide you through the SFDA registration process and help you prepare the required materials.

Basic Package (Single Document): 7–14 days Standard Package (Multiple Documents): 14–21 days Premium Package (Full Technical File): 4–6 weeks Expedited services are available upon request.

To begin, I’ll need: ✔ Device Name & Description ✔ Target Market & Intended Use ✔ Device Classification (Class I, II, or III) ✔ Existing Test Reports or Data (if available)

Yes! I offer post-submission support for an additional fee, depending on the required modifications.

Yes! I provide 1-on-1 regulatory consultations ($150–$250 per hour) to help you navigate SFDA requirements.

Yes! All documents are prepared according to SFDA standards, ensuring they are ready for regulatory review.

No problem! You can order additional documents separately, and I can provide a custom quote based on your needs.