For medical devices, cosmetics, food and medicines, Saudi Arabia’s gatekeeper is the Saudi Food and Drug Authority (SFDA). Indian device makers need a Medical Device Marketing Authorization (MDMA), submitted through GHAD by a Saudi Authorized Representative. Approval in a reference market such as the EU or USA is generally expected. PCN prepares the dossier and helps you choose the right AR.
| Medical devices | MDMA via GHAD by an AR holding an MDEL; typically valid 3 years |
|---|---|
| Reference approval | Prior approval in the EU, USA, Canada, Japan or Australia generally expected |
| Cosmetics | Product notification/listing via a Saudi party; Arabic labelling |
| Food | SFDA food safety and Arabic labelling rules |
| Medicines | Registration and GMP via a local agent |
No. A Saudi Authorized Representative with an MDEL submits it.
Generally yes. A reference approval is expected.
Typically three years.
Requirements, portals and fees change often. PCN confirms the applicable rules for each product before quoting. Certificates are issued by the relevant authority, accredited certification body or notified body.
Send your product name, HS code and destination. Our Delhi team will confirm the route, testing and timeline within 48 hours.
📞 +91 80109 05029 · ✉️ bdm@pcnindiaglobal.com
Related: Middle East Certification · EU MDR · US FDA · CDSCO (India)
One of India's leading independent consultancy bodies providing compliance, certification, and regulatory services to international and domestic players in electronics, IT, chemical, and electrical sectors.