As Saudi Arabia's Vision 2030 accelerates healthcare privatization and public hospital modernization, the National Unified Procurement Company (NUPCO) awards billions in medical consumable contracts annually. However, foreign manufacturers cannot participate without an active Medical Device Marketing Authorization (MDMA) issued via the Saudi Food and Drug Authority (SFDA) GHAD electronic system. Here is how leading Saudi distributors partner with Manshav Impex to fulfill NUPCO tenders.
Supplying Saudi Arabia's healthcare sector requires navigating the SFDA's unified GHAD portal, mandatory Saudi-DI serialization, and NUPCO centralized hospital tenders. Here is the step-by-step regulatory and logistics roadmap for medical importers.
Medical consumables imported into Saudi Arabia must hold an active SFDA MDMA certificate issued to an Authorized Representative (AR) licensed under an MDEL (Medical Device Establishment License). Manshav Impex provides fully authenticated technical dossiers conforming to Saudi GHTF guidance, Arabic/English bilingual packaging, and GS1 Saudi-DI barcodes. Ocean shipping from Mundra to Jeddah or Dammam takes only 5 to 7 sailing days.
The SFDA regulates medical devices under the Medical Devices Law issued by Royal Decree No. M/54. Registration is executed entirely online via the GHAD portal. Disposable consumables such as sterile surgical gloves, IV cannulas, and syringes are classified under Class I Sterile, Class IIa, or Class IIb.
| Registration Step | Responsible Party | Required Documentation | Statutory Timeline |
|---|---|---|---|
| 1. AR Appointment | Saudi Distributor & Manshav Impex | Legalized Authorized Representative Agreement (Chamber of Commerce) | 3 – 5 working days |
| 2. MDEL License Verification | Saudi Distributor | Valid SFDA Medical Device Establishment License (MDEL) | Pre-existing |
| 3. Technical File Compilation | Manshav Impex QA Team | ISO 13485:2016, CE Declaration, Free Sale Certificate (FSC), Biocompatibility | Immediate (Pre-compiled) |
| 4. GHAD Portal Submission | Saudi AR / Importer | Upload of bilingual artwork, Saudi-DI UDI code, test reports | 1 – 2 working days |
| 5. SFDA Scientific Review | SFDA Medical Device Sector | Verification of clinical evaluation, sterilization, and labeling | 15 – 30 working days |
| 6. MDMA Issuance | SFDA | Digital certificate granting 3-year market authorization | Instant upon approval |
The SFDA strictly enforces Unique Device Identification (Saudi-DI). Every single-use consumable package must carry a GS1 DataMatrix 2D barcode containing the Device Identifier (DI) registered in the Saudi UDI database, plus Production Identifiers (PI): lot number, expiry date, and manufacturing date.
NUPCO centralizes medical procurement for the Ministry of Health, Ministry of Defense, National Guard Health Affairs, and university teaching hospitals. Bidding is conducted through the digital Wasfaty and NUPCO tender portals. Key criteria for winning contracts include validated manufacturing capacity, competitive multi-year pricing, and rapid delivery cycles from Gulf logistics hubs.
| Target Product Category | Typical NUPCO Contract Size | Packaging Spec | Manshav Delivery Capability |
|---|---|---|---|
| Sterile Surgical Gloves | 2,000,000 – 5,000,000 Pairs | AQL 0.65, 50 pairs/box, bilingual | 40ft HC containers every 2 weeks |
| Safety IV Cannula (18G–24G) | 1,500,000 – 3,000,000 Pcs | Passive needle shield, ISO 10555-5 | 220,000 pcs per 20ft FCL |
| Auto-Disable Syringes (0.5ml) | 5,000,000 – 10,000,000 Pcs | WHO PQS E008, fixed needle | 1,480,000 pcs per 40ft HC |
| Synthetic PGA/Polyglactin Sutures | 50,000 – 150,000 Dozen | Laser-swaged 300 series needles | Consolidated air/sea shipments |
Shipping medical devices from India's west coast (Mundra / Nhava Sheva) to Saudi ports is one of the fastest maritime trade routes in global logistics. Direct vessel sailings take only 5 to 7 days to Jeddah Islamic Port (Red Sea) and 6 to 8 days to King Abdulaziz Port in Dammam (Arabian Gulf). Customs clearance via the FASAH single-window platform is typically completed in 48 to 72 hours with pre-cleared SABER/SFDA documentation.
Pre-donned sterile natural latex surgical gloves with curved anatomical fingers, micro-textured anti-slip finish, beaded cuff, available in powdered and powder-free polymer coated grades. Container consignments dispatched from Port Mundra & Port Nhava Sheva, with certificates and test reports shared with every quotation.
Foreign medical device manufacturers without a physical presence in the Kingdom must appoint a licensed Saudi company as their Authorized Representative. The AR holds the SFDA MDMA registration on behalf of the manufacturer and liaises with the SFDA for regulatory post-market vigilance.
Because Manshav Impex holds full ISO 13485:2016 certification and complete CE technical files, the scientific review through the GHAD portal typically takes between 15 and 30 working days from submission.
Yes. SFDA regulations mandate that medical device outer packaging and user instructions must be provided in Arabic and English, including product name, intended use, storage temperature limits, and precautions.
Most essential medical consumables (such as sterile gloves, syringes, and infusion sets under HS Code 9018) qualify for 0% to 5% basic customs tariff. An additional 15% VAT is applied, which registered medical distributors recover as input tax.
Yes. We offer complete OEM contract packaging with your Saudi trademark, registered Saudi-DI barcode, and Arabic packaging artwork formatted to meet SFDA guidelines.
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