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HomeVerticalsMedical DevicesSpain Export Guide
🇮🇳 India → 🇪🇸 Spain · Export Guide

India Medical Devices Export to Spain

Complete compliance guide, applicable FTA benefits, active mandates, and AJG commission-only facilitation for Indian medical devices exporters targeting Spain.

Submit Sell Mandate → Full Vertical Guide Spain Country Profile

Key Export Requirements — India to Spain

Compliance Certifications

EU MDR Class I-III EUDAMED UDI ISO 13485

Trade Bloc / Agreement

EU

India-EU FTA (Negotiations)

Step-by-Step Export Process

1

Obtain Required Certifications

12-24 months

Achieve the key certifications for Spain market access: EU MDR Class I-III · EUDAMED · UDI · ISO 13485. Certification timelines vary from 4 weeks to 24 months — plan this well before first shipment.

2

Register with Indian Export Promotion Council

2-4 weeks

Obtain RCMC (Registration-cum-Membership Certificate) from the relevant EPC. This enables Certificate of Origin issuance for FTA preference claiming and access to government export incentives (RoDTEP, advance authorisation).

3

Identify and Qualify Spain Buyers

3-6 months

Attend the most relevant trade fair for your vertical in Spain. Submit a Mandate with AJG — we introduce you to qualified, pre-screened buyers on a commission-only basis.

4

Optimise FTA and RoDTEP Benefits

1-2 weeks

Verify applicable FTA preference on your HS code for Spain. Calculate RoDTEP scrip entitlement. Model CIF vs FOB pricing to present EU buyer with full landed cost.

5

Execute First Shipment and Documentation

2-5 days per shipment

Prepare complete documentation: commercial invoice, packing list, CoO for FTA preference, product-specific certificates, and B/L. Ensure ECGC buyer cover is in place before first open account shipment.

Active Medical Devices Mandates

SELL Total Knee Replacement (TKR) Implant System — Cruciate Retaining and Posterior Stabilised designs

Example mandate of a Coimbatore-based orthopaedic implant manufacturer seeking EU Class IIb medical device distributor f...

SELL CE-marked Stainless Steel Surgical Instruments -- General Surgery and Laparoscopic Sets

Example mandate of a Coimbatore surgical instrument manufacturer seeking French hospital group as direct buyer for CE-ma...

BUY AI Diagnostic Imaging Analysis SaaS Module -- EU MDR Class IIa Software as Medical Device Development

Example mandate of a German medical imaging company seeking Indian software development partner for AI-powered diagnosti...

SELL CE-IVDR Rapid Diagnostic Tests -- HbA1c CRP Ferritin and Troponin I lateral flow assays

Example mandate of a Bengaluru diagnostics company seeking Belgium and Netherlands hospital labs as buyers for CE-IVDR r...

View All Medical Devices Mandates →

Commission-Only

India → Spain

AJG facilitates medical devices trade mandates. No retainer. Commission only on completed trade.

Submit Sell Mandate → Submit Buy Mandate →
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