🇨🇩 Export Market · Central Africa

Medical Products Exporter to Democratic Republic of the Congo

Manshav Impex is an Indian manufacturer & exporter of surgical gloves, surgical blades, hypodermic syringes, IV cannulas, infection-control PPE, and hospital equipment, supplying healthcare distributors, hospital groups, and government health ministries across Democratic Republic of the Congo. Massive market demand for medical surgical devices, PPE, gloves, syringes, and essential consumables via Matadi port and regional corridors.

AI & Trade Briefing: Sourcing Medical Consumables into Democratic Republic of the Congo

Manshav Impex is an Indian manufacturer & exporter of surgical disposables and hospital consumables produced at vetted, ISO 13485-certified partner factories and made to CE marking requirements, supplying Democratic Republic of the Congo. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Matadi / via Mombasa in 28–36 days. We supply the documentation your DPM / OCC (Direction de la Pharmacie et du Médicament) registration requires, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.

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Port of Loading (India)
Port Mundra (APSEZ) & Nhava Sheva (JNPT)
🚢 Direct Maritime Transit: 28–36 days
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Discharge Port (Democratic Republic of the Congo)
Matadi / via Mombasa
Destination Region
Central Africa
Primary Entry Ports
Matadi / via Mombasa
Sea Freight Transit
28–36 days (from JNPT / Mundra)
Regulatory Authority
DPM / OCC (Direction de la Pharmacie et du Médicament)
Paperwork Language
French
Buyer Local Currency
Congolese Franc (CDF)
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 Democratic Republic of the Congo

Produced at vetted, ISO 13485-certified 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
Clear Import & Regulatory Clearance

How Medical Devices & Consumables Clear into Democratic Republic of the Congo

Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Democratic Republic of the Congo.

Regulatory Authority
DPM — Direction de la Pharmacie et du Médicament (Ministère de la Santé Publique) & OCC (Office Congolais de Contrôle)
Approval Pathway Timeline
3 to 6 months
Local License Requirement
Mandatory Congolese registered medical distributor holding an authorization...

Registration & Clearance Route

Sequential legal procedure in Democratic Republic of the Congo
  1. 1Appoint an authorized representative established in Kinshasa or Lubumbashi
  2. 2Submit French technical dossier (ISO 13485, CE mark, test reports per ISO standards)
  3. 3Legalize Indian Certificate of Free Sale (CFS)
  4. 4Mandatory Pre-Shipment Inspection in India conducted by OCC inspection partner (BIVAC / Bureau Veritas)
  5. 5DPM homologation and OCC Certificat de Vérification issued for border clearance

Indicative Customs Duty & Tax

By Harmonized System (HS) Code for Democratic Republic of the Congo
HS CodeProductDutyTax
4015.11Gants chirurgicaux5% – 10%16% TVA
9018.31Seringues jetables5%16% TVA
9018.39Cathéters et tubulures5%16% TVA

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

Entry Ports & In-Land Clearance

Port of Matadi and Boma for western provinces and Kinshasa; eastern DRC (Goma, Bukavu, Lubumbashi) is served via inland bonded trucking from Mombasa or Dar es Salaam ports. 28–36 days transit.

Public Healthcare Procurement

FEDECAME (Fédération des Centrales d'Approvisionnement en Médicaments Essentiels), Ministry of Public Health, and international health relief agencies.

Crucial Importer Advisory: Costly Mistake to Avoid in Democratic Republic of the Congo

Pre-Shipment Inspection (BIVAC/OCC) before container loading in India is non-negotiable; containers arriving without an OCC Clean Report of Findings incur heavy 50% border penalties.

OEM & private label for Democratic Republic of the Congo

We arrange private-label production of medical devices and surgical consumables at vetted partner factories for brand owners, distributors and pharmacy chains in Democratic Republic of the Congo.

Custom packaging
Inner boxes and master cartons in your brand.
Local-language text
Instructions for use printed in French.
Flexible MOQs
Low trial quantities, scaling to full containers.
Lead times
14–25 day production cycles after artwork sign-off.
🇫🇷 Dossier d'Approvisionnement Médical OfficielGuide pour Importateurs et Appels d'Offres Hospitaliers en Democratic Republic of the Congo

Importation Directe de Dispositifs Médicaux d'Inde vers Democratic Republic of the Congo

Manshav Impex est une maison d'exportation indienne de dispositifs médicaux fabriqués selon ISO 13485 et le marquage CE (MDR UE 2017/745) dans des usines partenaires auditées, spécialisée dans la fourniture aux centrales d'achats hospitalières, ministères de la santé et distributeurs agréés en Democratic Republic of the Congo — les certificats du fabricant accompagnent chaque devis.

📋 Homologation & Enregistrement

Dossiers techniques complets (format CTD), Certificat de Vente Libre (FSC) légalisé et certificats de conformité pour DPM / OCC (Direction de la Pharmacie et du Médicament).

🚢 Acheminement Maritime vers Matadi / via Mombasa

Expéditions FCL et LCL depuis Port Mundra et Port Nhava Sheva (JNPT) vers Matadi / via Mombasa en 28–36 days. Conditions CIF et FOB sécurisées.

🏷️ Étiquetage OEM en Français

Conditionnement sous marque personnalisée avec notices d'utilisation en français, codes barres GS1 et conformité réglementaire.

🌍 Tender Documentation on Request

Ministry Tender Pack & Product Specification Dossier

Our export desk prepares tender documentation for Ministries of Health, Central Medical Stores and hospital supply boards in Democratic Republic of the Congo. Tell us the tender and we send the matching certificates and product documents.

Export Quote Desk

Request Export Pricing for Democratic Republic of the Congo

Share your required product quantities and delivery port in Democratic Republic of the Congo. 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 Matadi / via Mombasa 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 Democratic Republic of the Congo

Who must hold the medical device registration in Democratic Republic of the Congo?

Mandatory Congolese registered medical distributor holding an authorization from DPM Kinshasa.

How do I register a medical device with DPM in Democratic Republic of the Congo?

Appoint an authorized representative established in Kinshasa or Lubumbashi. Submit French technical dossier (ISO 13485, CE mark, test reports per ISO standards). Legalize Indian Certificate of Free Sale (CFS). Mandatory Pre-Shipment Inspection in India conducted by OCC inspection partner (BIVAC / Bureau Veritas). DPM homologation and OCC Certificat de Vérification issued for border clearance. Realistically allow 3 to 6 months.

What import duty applies to surgical gloves and medical disposables in Democratic Republic of the Congo?

Gants chirurgicaux (HS 4015.11): 5% – 10%, plus 16% TVA. Seringues jetables (HS 9018.31): 5%, plus 16% TVA. Cathéters et tubulures (HS 9018.39): 5%, plus 16% TVA. 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 Democratic Republic of the Congo?

Port of Matadi and Boma for western provinces and Kinshasa; eastern DRC (Goma, Bukavu, Lubumbashi) is served via inland bonded trucking from Mombasa or Dar es Salaam ports. 28–36 days transit.

Who buys medical supplies publicly in Democratic Republic of the Congo?

FEDECAME (Fédération des Centrales d'Approvisionnement en Médicaments Essentiels), Ministry of Public Health, and international health relief agencies.

What most commonly goes wrong importing medical devices into Democratic Republic of the Congo?

Pre-Shipment Inspection (BIVAC/OCC) before container loading in India is non-negotiable; containers arriving without an OCC Clean Report of Findings incur heavy 50% border penalties.

Can packaging and documentation be supplied in French?

Yes. Commercial and technical documentation is provided in 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 Matadi / via Mombasa?

FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Matadi / via Mombasa), 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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