If you’re a US, EU or UK-based MedTech manufacturer shipping Class A, B, C or D devices into India, this is the exact 2026 roadmap you need to clear customs, avoid costly delays, and start selling in one of the world’s fastest-growing markets.
I’m guiding you through every step of the MD-15 process on the SUGAM portal, highlighting how your FDA, CE, or UKCA approvals give you a head start, so you can avoid delays and achieve faster market entry.
Stick around – this is the no-fluff, Tier-1 focused guide that turns 6–9 month waits into smooth market entry. Let’s dive in.
What Exactly is Form MD-15 in 2026?
Form MD-15 is the official “Licence to Import Medical Device” issued by India’s Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017.
You apply in Form MD-14 → CDSCO grants you Form MD-15 (the actual import license).
One MD-15 license covers one overseas manufacturing site + your full list of approved devices. It is issued to your Authorised Indian Agent and is valid in perpetuity – you simply pay a retention fee every 5 years.
As of April 2026, virtually every imported medical device requires this licence before it can legally enter India. No MD-15 = shipment held at customs.
Why US, EU & UK Manufacturers Need This Right Now
India’s med-tech market is exploding, and regulators give fast-track recognition to devices already cleared in reference countries.
If you hold a US FDA 510(k)/PMA, EU MDR/IVDR CE marking, or UKCA certification, you already possess 70–80 % of what CDSCO requires. This should give you confidence that leveraging these approvals can streamline your MD-15 process, making your journey feel more manageable.
Step-by-Step: How US, EU & UK Companies Get Form MD-15 in 2026
- Classify your device – Class A, B, C or D risk level (use CDSCO guidance or our free checklist).
- Appoint an Authorised Indian Agent – must hold a valid wholesale or manufacturing licence in India (we recommend partners experienced with US/EU/UK clients).
- Prepare your Tier-1 documentation pack (detailed below).
- Submit Form MD-14 via the fully digital SUGAM portal and pay the applicable fees.
- CDSCO technical review + possible site inspection – typical 6–9 months.
- Receive your Form MD-15 → legal imports begin immediately!
Pro tip for US/EU/UK teams: Your existing Free Sale Certificate from the FDA, EU competent authority or MHRA is considered gold-standard reference documentation.
- Exact documents US, EU & UK manufacturers need in 2026 include Power of Attorney (notarised/apostilled), Free Sale Certificates, ISO 13485 certificate, and recent audit reports. Having this checklist can help you feel more prepared and confident in your application process.Power of Attorney (notarised/apostilled) + undertaking
- Free Sale Certificate from the country of origin (FDA / EU / MHRA)
- Additional Free Sale Certificate from a second GHTF country (highly recommended)
- ISO 13485 / full QMS certificate
- Plant Master File (Appendix I) & Device Master File (Appendix II)
- Declaration of Conformity
- Latest inspection/audit reports (FDA, EU Notified Body or MHRA reports = huge advantage)
Class C & D devices may require extra clinical or scientific data, but your existing US/EU/UK technical files usually cover it.
Timeline & Fees – What to Budget in 2026
- Timeline: 6–9 months (faster with clean, apostilled documents and quick query responses)
- Fees: Plant registration fee + per-product fee (higher for Class C/D)
- Validity: Perpetual with a 5-year retention fee
Real Talk from US, EU & UK Clients Already Shipping to India
In 2026, the SUGAM portal is smoother than ever, but queries still arise if your POA isn’t properly apostilled or if Master Files miss a single appendix. Partnering with an experienced Indian regulatory team who understands FDA/MDR/MHRA language can make your clearance process feel more secure and less daunting.
Want the Full 2026 Checklist + Sample MD-15?
Drop your device class (A/B/C/D) and country (US, Germany, UK, France, etc.) in the comments, and I’ll send you the latest downloadable checklist + SUGAM portal tips straight to your inbox.
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Got questions on MD-15 vs your existing FDA/CE/UKCA approvals, how this affects your supply chain, or need help appointing the right Authorised Indian Agent? Comment below – our team answers every single one, and many of you become clients because we make compliance simple.
Until next time, stay compliant and keep dominating Tier-1 markets!
Real Regulatory Insights – Simplifying global med-tech compliance. 🇺🇸🇪🇺🇬🇧🇮🇳
Video Description (copy-paste ready for YouTube): MD-15 Import License India – Step-by-Step for US, EU & UK Manufacturers 2026 Update
✅ Full MD-14 to MD-15 process on SUGAM portal
✅ Exact documents that speed up approval for American, European & British companies
✅ Timeline, fees, retention & common pitfalls in 2026
Timestamps in pinned comment.
Resources & checklists linked in comments. Comment your device class + country for personalised help!
Which part was most helpful? Let me know below, and I’ll create follow-up videos on the MD-42 registration or retention process next!