🇸🇦 Export Market · Middle East

Medical Products Exporter to Saudi Arabia

Indian manufacturer & exporter of surgical gloves, blades, syringes, IV cannulas and PPE for distributors, hospitals and health ministries in Saudi Arabia.

Trade lane · India → Saudi Arabia
Loading ports
🇮🇳 Mundra & Nhava Sheva
Discharge ports
🇸🇦 Jeddah Islamic Port, King Abdulaziz Port Dammam
Sea transit
10–14 days
Regulator
SFDA (Saudi Food and Drug Authority)

Large hospital network and government-procurement market with full SFDA technical dossier support for import registration.

In short: sourcing medical consumables for Saudi Arabia

Manshav Impex is an Indian manufacturer & exporter of surgical disposables and hospital consumables produced in our own ISO 13485-certified factory and at vetted partner factories and made to CE marking requirements, supplying Saudi Arabia. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Jeddah Islamic Port, King Abdulaziz Port Dammam in 10–14 days. We supply the documentation your SFDA (Saudi Food and Drug Authority) registration requires, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.

Paperwork Language
Arabic & English
Buyer Local Currency
Saudi Riyal (SAR)
Made to Standards
CE MDR · ISO 13485 · EN 455 · EN 13795
Export Paperwork SLA
24-Hour Complete Dossier Guarantee
Technical Product Portfolio

High-Precision Medical Consumables Exported to Saudi Arabia

Produced in our own ISO 13485-certified factory and at vetted partner factories in India with 100% lot traceability — certificates and test reports are shared with every quotation.

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, 400 pairs/master carton (OEM private label available)

Surgical Blades & Scalpels

HS 9018.90 · 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
Import & Regulatory Clearance

How Medical Devices Clear into Saudi Arabia

Who registers, the steps in order, and the indicative duty on the main HS lines.

Regulatory Authority
SFDA — Saudi Food and Drug Authority
Approval Pathway Timeline
6–12 months
Local License Requirement
Mandatory.

Registration & Clearance Route

Sequential legal procedure in Saudi Arabia
  1. 1Appoint a Saudi Authorised Representative and register them with the SFDA
  2. 2Manufacturer supplies ISO 13485, CE Declaration of Conformity and Free Sale evidence
  3. 3MDMA application filed through the SFDA system
  4. 4Technical review against the applicable class
  5. 5MDMA issued; the product may then be imported and marketed

Indicative Customs Duty & Tax

By Harmonized System (HS) Code for Saudi Arabia
HS CodeProductDutyTax
4015.12Surgical and examination gloves5% GCC common external tariff15% VAT
9018.90Other instruments and appliances5% GCC common external tariff15% VAT

Indicative tariffs verified against HS classifications. Actual tariff treatment is governed by local customs declaration schedules. Checked May 2026.

Pre-Shipment Conformity Inspection

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.

Entry Ports & In-Land 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 Healthcare Procurement

NUPCO is the central procurement and logistics company for the public health system. Ministry of Health facilities buy through it.

Crucial Importer Advisory: Costly Mistake to Avoid in 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.

OEM & private label for Saudi Arabia

We manufacture private-label medical devices and surgical consumables in our own factory and at vetted partner factories for brand owners, distributors and pharmacy chains in Saudi Arabia.

Custom packaging
Inner boxes and master cartons in your brand.
Local-language text
Instructions for use printed in Arabic & English.
Flexible MOQs
Low trial quantities, scaling to full containers.
Lead times
14–25 day production cycles after artwork sign-off.
🇸🇦 / 🇦🇪 ملف التوريد الطبي الرسميدليل استيراد المستلزمات الطبية والمناقصات الحكومية في Saudi Arabia

تصدير المستلزمات الطبية والأجهزة الجراحية من الهند إلى Saudi Arabia

شركة مانشاف إمبكس (Manshav Impex) هي بيت تصدير هندي يورّد قفازات جراحية معقمة، شفرات جراحية، محاقن، وقساطر وريدية مصنّعة وفق معايير ISO 13485 وعلامة CE الأوروبية في مصانع شريكة مدقّقة، لتلبية احتياجات المستشفيات والمناقصات الحكومية في Saudi Arabia (SFDA (Saudi Food and Drug Authority))، مع إرفاق شهادات الجهة المصنّعة بكل عرض سعر.

📋 الملفات الفنية والتسجيل

ملفات تسجيل فنية كاملة متوافقة مع متطلبات SFDA (Saudi Food and Drug Authority) وشهادات التحليل المخبري.

🚢 الشحن المباشر إلى Jeddah Islamic Port, King Abdulaziz Port Dammam

شحن بحري حاويات كاملة FCL وجزئية LCL من موانئ موندرا ونافا شيفا إلى Jeddah Islamic Port, King Abdulaziz Port Dammam خلال 10–14 days. أسعار CIF وFOB تنافسية.

🏷️ التغليف باللغتين العربية والإنجليزية

طباعة العبوات والكراتين ببيانات ثنائية اللغة تشمل أرقام التشغيلات وتواريخ الصلاحية والباركود الدولي GS1.

Export Quote Desk

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.

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Frequently Asked Questions

Exporting Medical Consumables to Saudi Arabia

Mandatory. An Authorised Representative established in Saudi Arabia holds the MDMA (Medical Device Marketing Authorisation) and is legally answerable for the product.
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.
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.
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.
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.
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.
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.
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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