Medical Products Exporter to Rwanda
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 Rwanda. Fast-growing healthcare hub importing CE & ISO certified surgical consumables, infusion sets, and hospital equipment for RMS tenders.
Manshav Impex is an established Indian manufacturer and direct exporter of CE, ISO 13485:2016, and WHO-GMP certified surgical disposables and hospital consumables to Rwanda. Shipped directly from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to via Mombasa / Dar es Salaam in 18–24 days. Full regulatory dossiers are provided for Rwanda FDA (Food and Drugs Authority) compliance, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.
High-Precision Medical Consumables Exported to Rwanda
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 & Consumables Clear into Rwanda
Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Rwanda.
Registration & Clearance Route
- 1Partner with an authorized Rwandan distributor holding an active Wholesale Dealer License
- 2Submit online technical dossier via Rwanda FDA portal (ISO 13485:2016, CE certificate, FSC, clinical summary)
- 3Rwanda FDA scientific evaluation and Marketing Authorization issue
- 4Electronic import permit obtained prior to shipment departure from India
Entry Ports & In-Land Clearance
Inland bonded transit from Port of Mombasa (Northern Corridor) or Port of Dar es Salaam (Central Corridor) to Kigali in 18–24 days. Air freight to Kigali International Airport (KGL).
Public Healthcare Procurement
RMS (Rwanda Medical Supply Ltd) central tenders, King Faisal Hospital, and University Teaching Hospital of Kigali (CHUK).
Product labeling must strictly comply with Rwanda FDA labeling guidelines in English or French, stating batch, sterile barrier method, and storage conditions.
OEM & private label for Rwanda
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Rwanda.
Importation Directe de Dispositifs Médicaux d'Inde vers Rwanda
Manshav Impex est un fabricant et exportateur indien certifié ISO 13485:2016 et CE (MDR UE 2017/745), spécialisé dans la fourniture directe aux centrales d'achats hospitalières, ministères de la santé et distributeurs agréés en Rwanda.
Dossiers techniques complets (format CTD), Certificat de Vente Libre (FSC) légalisé et certificats de conformité pour Rwanda FDA (Food and Drugs Authority).
Expéditions FCL et LCL depuis Port Mundra et Port Nhava Sheva (JNPT) vers via Mombasa / Dar es Salaam en 18–24 days. Conditions CIF et FOB sécurisées.
Conditionnement sous marque personnalisée avec notices d'utilisation en français, codes barres GS1 et conformité réglementaire.
Pan-African Ministry Tender Pack & Product Specification Dossier (PDF)
Download the comprehensive institutional tender dossier prepared for Ministries of Health, Central Medical Stores, and hospital supply boards across Rwanda and 54 African nations.
Explore Full Medical Range for Rwanda
Request Export Pricing for Rwanda
Share your required product quantities and delivery port in Rwanda. 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 via Mombasa / Dar es Salaam with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Rwanda
Who must hold the medical device registration in Rwanda?
Mandatory licensed Rwandan company with a Premise Registration Certificate from Rwanda FDA.
How do I register a medical device with Rwanda FDA in Rwanda?
Partner with an authorized Rwandan distributor holding an active Wholesale Dealer License. Submit online technical dossier via Rwanda FDA portal (ISO 13485:2016, CE certificate, FSC, clinical summary). Rwanda FDA scientific evaluation and Marketing Authorization issue. Electronic import permit obtained prior to shipment departure from India. Realistically allow 2 to 4 months (streamlined online regulatory portal).
What import duty applies to surgical gloves and medical disposables in Rwanda?
Surgical gloves (HS 4015.11): 0% – 10% (EAC CET), plus 18% VAT (exempt on certified medical equipment). Disposable syringes (HS 9018.31): 0%, plus 18% VAT. IV cannulas (HS 9018.39): 0%, plus 18% 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 Rwanda?
Inland bonded transit from Port of Mombasa (Northern Corridor) or Port of Dar es Salaam (Central Corridor) to Kigali in 18–24 days. Air freight to Kigali International Airport (KGL).
Who buys medical supplies publicly in Rwanda?
RMS (Rwanda Medical Supply Ltd) central tenders, King Faisal Hospital, and University Teaching Hospital of Kigali (CHUK).
What most commonly goes wrong importing medical devices into Rwanda?
Product labeling must strictly comply with Rwanda FDA labeling guidelines in English or French, stating batch, sterile barrier method, and storage conditions.
Can packaging and documentation be supplied in English or French?
Yes. Commercial and technical documentation is provided in English & French, 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 via Mombasa / Dar es Salaam?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (via Mombasa / Dar es Salaam), 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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