Many European medical device manufacturers (from Germany, France, UK, Netherlands, Italy, Switzerland, Ireland, Sweden, and other EU/EEA countries) want to import and sell in India’s fast-growing market. The MD-14 process (application for Form MD-15 import license) is mandatory for Class A (sterile/measuring), B, C, and D devices. Since October 2023, even most Class A devices require this license before import.
India’s CDSCO gives special advantages to devices with CE marking (from EU Notified Bodies), as the EU is a recognized GHTF/IMDRF reference market (along with USA, UK, Canada, Japan, Australia). This often speeds up review and reduces scrutiny compared to non-reference countries.
Below is a complete FAQ in simple USA English, focused on European manufacturers/importers who want to export to India.
General FAQs
Everything you need to know about purchases, invoices and billings. Can’t find an answer? Get in touch →
1. Do European medical devices need an MD-14 / MD-15 import license to enter India?
Yes – mandatory for almost all devices.
Without MD-15, customs will hold or reject shipments, and your Indian distributor cannot legally sell.
As of 2026: All Class A (sterile or measuring), Class B, C, and D medical devices require a CDSCO import license (Form MD-15) before commercial import and sale.
Non-sterile, non-measuring Class A devices may still need registration but not always full MD-15 (check current CDSCO list).
2. What makes Europe special for CDSCO approvals?
EU countries benefit from faster and smoother MD-14 review because:
Timelines are often 4–7 months for CE-marked Class B devices (vs 6–12 months for others).
CE marking from EU Notified Bodies is accepted as strong evidence of conformity (similar to FDA 510(k)/PMA).
CDSCO recognizes EU as a GHTF founding member/reference market → you can submit CE certificates, Declaration of Conformity, and Notified Body opinions instead of full re-testing in many cases.
3. Who submits the MD-14 application?
Not the European manufacturer directly.
- Foreign manufacturers cannot apply alone.
- You must appoint an Authorized Indian Agent (IAA) in India.
- The IAA must hold a valid MD-42 wholesale license (or manufacturing license) and submits Form MD-14 via the SUGAM portal on your behalf.
- You give the IAA a notarized, apostilled Power of Attorney (PoA).
4. What are the main documents required for MD-14 from European manufacturers?
CDSCO accepts EU documents (duly notarized/apostilled). Core list (2026):
- Covering letter (from IAA)
- Form MD-14 (filled on SUGAM portal)
- Power of Attorney + undertaking (apostilled by Indian Embassy or Hague Apostille)
- IAA’s MD-42 wholesale license copy
- Free Sale Certificate (FSC) or Marketing Authorization from your EU country’s authority (notarized)
- CE marking documents (highly preferred):
- Full Quality Assurance Certificate / CE Type Examination Certificate / CE Design Certificate (as applicable)
- Declaration of Conformity (DoC) issued by manufacturer
- ISO 13485:2016 certificate of the actual manufacturing site (notarized)
- Plant Master File (PMF) – site layout, equipment, QMS (Appendix I)
- Device Master File (DMF) – full technical dossier (Appendix II):
- Device description, intended use, specifications
- Risk management (ISO 14971 summary)
- Biocompatibility, sterilization (if applicable)
- Stability data
- Clinical evidence / evaluation report
- Labeling / IFU (English + Hindi if required for patient use)
- Batch release / CoA for 3 batches
- Fee payment proof (online via SUGAM)
- Any additional: latest Notified Body audit report (last 3 years), post-market surveillance data
- EU advantage: CE technical file + DoC + Notified Body certificates usually satisfy most DMF requirements, reducing extra testing.
5. What fees apply for MD-14 from Europe?
Average Fees in USD (Practical Examples – March 2026)
Most foreign manufacturers pay $1,000 to $6,000+ total government fee depending on class and number of devices/sites. Here are realistic averages:
Simple Class A (sterile/measuring) or low-complexity device (1 site, 1–2 variants): Average ≈ $1,050–$1,500 (base $1,000 site + $50–$500 per device)
Typical Class B device (1 site, 3–5 variants): Average ≈ $4,000–$7,000 (base $2,000 site + $1,000 × 3–5 devices)
Class C or Class D device (1 site, 2–4 variants, common for implants/diagnostics): Average ≈ $6,000–$10,000 (base $3,000 site + $1,500 × 2–4 devices)
Higher-end scenario (Class C/D + multiple sites + 10+ variants): Average ≈ $15,000–$25,000+ (plus possible $6,000 inspection)
These are government fees only — paid directly to CDSCO via SUGAM. Total project cost (including IAA fees, dossier preparation, consultant, apostille, translations) usually adds $5,000–$20,000 extra for European/US firms.
Important: Fees are in USD equivalent but paid in INR at current exchange rate (around 91.80–92.10 INR per USD in March 2026). Slight fluctuations happen daily.
If your device is CE-marked (from EU Notified Body), you often get faster processing and fewer queries — which saves time/money overall.
Need exact fee calculation for your device? Contact Us! Our Delhi team calculates precise MD-14 fees (government + total estimated cost) for free during consultation. Send your device class, number of variants, sites, and CE certificate details.
Extra per variant/site. Pay online on SUGAM.
6. How long does MD-14 approval take for CE-marked EU devices?
Class A/B (CE-marked): 4–7 months (fast-track possible)
Class C/D: 6–12 months (more scrutiny, possible site acceptance based on Notified Body)
Queries common → reply within 30–90 days.
Faster if dossier is complete and uses strong CE evidence.
7. Does CDSCO accept CE marking directly? Do I still need full testing in India?
Yes – CE is highly accepted as reference evidence (EU = GHTF member).
No mandatory re-testing for most CE-marked devices.
CDSCO may accept Notified Body audit reports instead of full Indian site inspection (especially for Class B/C).
Still need complete DMF + labeling compliant with Indian rules (manufacturer + IAA details, import license number once granted).
8. What happens after MD-15 is granted?
License valid 5 years (renew via retention).
Import only approved devices/models.
Report adverse events/vigilance within 15 days.
Notify changes (design, site) via Form MD-26.
Customs clearance requires MD-15 copy + invoice/packing list.
9. Common mistakes European companies make
Using IAA without valid MD-42 license → rejection
Submitting non-apostilled PoA → delay
Labeling only in English (no Hindi for patient-facing) → query
Incomplete clinical evaluation or missing batch CoAs → rejection
Wrong device grouping/GMDN codes → extra fees/queries
10. How can European manufacturers start the process quickly?
Classify device (use CDSCO list or IMDRF).
Appoint reliable IAA with MD-42 license.
Prepare apostilled PoA + CE dossier.
Get IAA to register on SUGAM and file MD-14.
Respond fast to queries.
Free 30-minute consultation: Send your CE certificate + device details for gap analysis and timeline estimate. We’ve helped 150+ EU companies secure fast MD-15 approvals.
By Mark Smith Follow us on X @realnewshubs and subscribe for push notifications