Manufacturing Licences for Class C & D Devices
High-risk medical devices regulated centrally by CDSCO. Includes manufacturing and loan licences with deeper QMS scrutiny. Requires an ISO 13485-aligned quality system, an in-house testing infrastructure, and a joint inspection by CDSCO and State authorities. Expect 6–9 months end-to-end once the technical file is complete, with classification rationale being the most scrutinised section of the dossier.
4 CDSCO forms in this category
Application for Grant of Licence to Manufacture for Sale and Distribution of Class C or Class D Medical Devices
Application for manufacturing license for Class C or D medical devices.
Application for Grant of Loan Licence to Manufacture for Sale or Distribution of Class C or Class D Medical Devices
Application for a loan license to manufacture Class C or D medical devices.
Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices
License granted for manufacturing and distribution of Class C or D medical devices.
Loan Licence to Manufacture for Sale or Distribution of Class C or Class D Medical Devices
Loan license issued for manufacturing and distribution of Class C or D medical devices.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Class C devices
Moderate-to-high risk: ventilators, dialysis machines, anaesthesia machines, infusion pumps.
Class D devices
Highest risk: implantable cardiac devices, active implantables, neuro stimulators, life-support equipment.
Mature QMS
Fully implemented ISO 13485 with at least one complete audit cycle.
Design controls
Documented design history file, risk management, design verification and validation.
Documentation checklist
- Comprehensive QMS documentation
- Design history file (DHF)
- Risk management file (ISO 14971)
- Clinical evaluation report
- Process validation evidence (3 batches)
- Stability data (full shelf-life)
- Biocompatibility test reports
- Sterilisation validation (if applicable)
- Software lifecycle documentation (if applicable)
Step by step
- 01
Pre-submission preparation
2-3 internal audits, mock external audit, CAPA closure, design file readiness.
- 02
MD-7 / MD-8 filing
Application via SUGAM to CDSCO Central Licensing Authority.
- 03
Technical review
CDSCO assessors evaluate technical file before site visit.
- 04
Facility audit
On-site inspection — full QMS, design controls, manufacturing scrutiny.
- 05
Query rounds (if needed)
Most clean dossiers clear without queries; some need targeted clarifications.
- 06
Licence issuance (MD-9 / MD-10)
Manufacturing licence granted, valid in perpetuity subject to compliance.
Common questions
Typical timeline is 8–12 weeks for clean dossiers. Class D and novel devices can take 6+ months including clinical data review.
A predicate strengthens substantial-equivalence claims and reduces clinical evidence burden. For novel devices, see the Novel Device Pathway page.
Class D submissions receive the most rigorous review: more inspection time, deeper clinical evidence expectations, post-market surveillance commitments.
SaMD has additional documentation requirements: software lifecycle, cybersecurity controls, clinical validation. We handle these.
CDSCO offers expedited review for genuinely novel devices in priority therapeutic areas. We help structure such applications.
Need help with class c/d manufacturing?
We'll send a fixed-fee quote and indicative timeline within 48 hours.
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