Medical Products Exporter to Saudi Arabia
Manshav Impex is a premier Indian OEM manufacturer and global exporter of certified surgical gloves, surgical blades, hypodermic syringes, IV cannulas, infection-control PPE, and hospital equipment to healthcare distributors, hospital groups, and government health ministries across Saudi Arabia. Large hospital network and government-procurement market with full SFDA technical dossier support for import registration.
High-Precision Medical Consumables for Saudi Arabia
Manufactured in Class 100,000 (ISO Class 8) cleanrooms under strict ISO 13485:2016 and WHO-GMP protocols with 100% lot traceability.
Surgical Gloves
HS 4015.11 · AQL 1.0- ✔Standards: EN 455 (Parts 1–4), ASTM D3577, ISO 10282, CE 2797
- ✔Specifications: 280 mm minimum beaded cuff, micro-textured grip, low protein (<50 µg/dm²)
- ✔Sterilization: Ethylene Oxide (EO) / Gamma Radiation (25 kGy) with sterile peel-pouch
- ✔Packaging: 50 pairs/dispenser box, 200 pairs/master carton (OEM private label available)
Surgical Blades & Scalpels
HS 8211.91 · ISO 7740- ✔Standards: BS 2982, ISO 7740, EN ISO 11607 sterile barrier packaging
- ✔Material: Grade T10/1095 High-Carbon Steel & AISI 420 Surgical Stainless Steel
- ✔Sizes: No. 10, 11, 12, 15 (Handle #3) and No. 18, 20, 21, 22, 23, 24 (Handle #4)
- ✔Sterilization & Packaging: Gamma irradiated 25 kGy in airtight VCI foil packets; 100 pcs/box
Syringes & IV Cannulas
HS 9018.31 / 9018.39- ✔Standards: ISO 7886-1, ISO 10555-1/5, ISO 8536-4, Non-pyrogenic & DEHP-free
- ✔Syringes: 2-part & 3-part Luer Lock / Luer Slip (1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 50ml)
- ✔IV Cannulas: 14G–26G with injection port & radio-opaque FEP/PTFE catheter wings
- ✔Needle Quality: Ultra-sharp siliconized triple-facet Japanese stainless steel needle
Surgical Gowns & Infection PPE
HS 6210.10 · AAMI Level 3/4- ✔Standards: AAMI PB70 Level 3/4 fluid barrier protection, EN 13795 clinical compliance
- ✔Fabric: 45–55 GSM medical-grade SMS / SMMS non-woven with ultrasonic welded seams
- ✔Face Masks: Type IIR EN 14683 3-ply surgical masks (BFE ≥ 98%, fluid resistance 120 mmHg)
- ✔Drapes & Packs: Sterile laparotomy drapes, ophthalmic packs and universal surgical kits
How medical devices actually clear into Saudi Arabia
Regulator & registration
- Authority
- SFDA — Saudi Food and Drug Authority
- Governing instrument
- Medical Devices Interim Regulation; devices are listed on the SFDA's GHAD system
- Classification
- Class I, IIa, IIb, III
- Local representative
- Mandatory. An Authorised Representative established in Saudi Arabia holds the MDMA (Medical Device Marketing Authorisation) and is legally answerable for the product.
- Realistic timeline
- 6–12 months
Registration route, in order
- Appoint a Saudi Authorised Representative and register them with the SFDA
- Manufacturer supplies ISO 13485, CE Declaration of Conformity and Free Sale evidence
- MDMA application filed through the SFDA system
- Technical review against the applicable class
- MDMA issued; the product may then be imported and marketed
Pre-shipment conformity
SABER/SALEEM — a Product Certificate of Conformity and then a Shipment Certificate must be raised electronically before arrival. This is separate from, and additional to, the SFDA device authorisation, and both are required.
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and examination gloves | 5% GCC common external tariff | 15% VAT |
| 9018.90 | Other instruments and appliances | 5% GCC common external tariff | 15% VAT |
Indicative and tied to the HS heading shown. Tariff lines change and your exact classification governs — confirm against the current schedule before pricing. Checked May 2026.
Ports & clearance
Jeddah Islamic Port serves the west and the Red Sea corridor; King Abdulaziz Port at Dammam serves the Eastern Province and the Gulf. Both are well run. Local content preferences under Vision 2030 increasingly shape large public tenders.
Public procurement
NUPCO is the central procurement and logistics company for the public health system. Ministry of Health facilities buy through it.
Treating SABER as interchangeable with the SFDA authorisation. They are two independent gates and a shipment needs both — clearing one does not progress the other.
OEM & private label for Saudi Arabia
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Saudi Arabia.
Explore Full Medical Range for Saudi Arabia
Request Export Pricing for Saudi Arabia
Share your required product quantities and delivery port in Saudi Arabia. Our international trade desk will provide formal CIF/FOB pricing, specification sheets, and regulatory support within 24 business hours.
Direct Ocean & Air Shipping
FCL & LCL container routing to Jeddah Islamic Port, King Abdulaziz Port Dammam with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Saudi Arabia
Who must hold the medical device registration in Saudi Arabia?
Mandatory. An Authorised Representative established in Saudi Arabia holds the MDMA (Medical Device Marketing Authorisation) and is legally answerable for the product.
How do I register a medical device with SFDA in Saudi Arabia?
Appoint a Saudi Authorised Representative and register them with the SFDA. Manufacturer supplies ISO 13485, CE Declaration of Conformity and Free Sale evidence. MDMA application filed through the SFDA system. Technical review against the applicable class. MDMA issued; the product may then be imported and marketed. Realistically allow 6–12 months.
Is pre-shipment inspection or a conformity certificate required for Saudi Arabia?
SABER/SALEEM — a Product Certificate of Conformity and then a Shipment Certificate must be raised electronically before arrival. This is separate from, and additional to, the SFDA device authorisation, and both are required.
What import duty applies to surgical gloves and medical disposables in Saudi Arabia?
Surgical and examination gloves (HS 4015.12): 5% GCC common external tariff, plus 15% VAT. Other instruments and appliances (HS 9018.90): 5% GCC common external tariff, plus 15% VAT. These are indicative against the HS headings shown and were checked May 2026 — your exact classification governs, so confirm against the current tariff schedule before pricing.
Which port should I use for medical imports into Saudi Arabia?
Jeddah Islamic Port serves the west and the Red Sea corridor; King Abdulaziz Port at Dammam serves the Eastern Province and the Gulf. Both are well run. Local content preferences under Vision 2030 increasingly shape large public tenders.
Who buys medical supplies publicly in Saudi Arabia?
NUPCO is the central procurement and logistics company for the public health system. Ministry of Health facilities buy through it.
What most commonly goes wrong importing medical devices into Saudi Arabia?
Treating SABER as interchangeable with the SFDA authorisation. They are two independent gates and a shipment needs both — clearing one does not progress the other.
Can packaging and documentation be supplied in Arabic or English?
Yes. Commercial and technical documentation is provided in Arabic & English, and artwork for inner dispenser boxes, sterile peel-pouches and master carton markings is prepared with local regulatory text, batch numbers, manufacturing and expiry dates, and GS1 EAN-13 barcodes.
What Incoterms are available for delivery to Jeddah Islamic Port, King Abdulaziz Port Dammam?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Jeddah Islamic Port, King Abdulaziz Port Dammam), and DDP. Cargo ships as FCL (20ft / 40ft HC) or LCL consolidation with humidity-protected packaging and marine insurance. Air freight is available for urgent hospital requirements.
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