Manufacturing Licences for Class A & B Devices
Low and moderate-risk medical devices regulated under the State Licensing Authority. Includes manufacturing and loan licences. Issued by your State Drugs Controller and valid perpetually until suspended or cancelled — no fixed-period renewals. Typical approval window is 4–6 weeks for a clean application with the QMS and site readiness already in place.
4 CDSCO forms in this category
Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B Medical Devices
Application for manufacturing license for Class A or B medical devices.
Application for Grant of Loan Licence to Manufacture for Sale or Distribution of Class A or Class B Medical Devices
Application for a loan license to manufacture Class A or B medical devices.
Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Devices
License issued for the manufacture and distribution of Class A or B medical devices.
Loan Licence to Manufacture for Sale or Distribution of Class A or Class B Medical Devices
Loan license granted for manufacturing and distribution of Class A or B medical devices.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Class A devices
Lowest-risk devices: thermometers, surgical drapes, examination gloves, oxygen masks.
Class B devices
Low-to-moderate risk: hypodermic needles, suction equipment, hearing aids, contact lenses.
Manufacturing facility
GMP-compliant premises in India with appropriate cleanroom classification per device.
Quality management system
Documented ISO 13485-aligned QMS, technical personnel, test infrastructure.
Documentation checklist
- Site master file and plant layout
- List of equipment with calibration records
- Technical staff qualifications and experience
- Device master file (DMF) per product
- Quality manual and SOPs
- Stability and shelf-life data
- Risk management report (ISO 14971)
- Application fee challan
Step by step
- 01
Pre-application QMS readiness
Internal audit, documentation gap closure, equipment qualification.
- 02
MD-3 / MD-4 filing via SUGAM
Application + technical file + fee submitted to State Licensing Authority.
- 03
Site inspection
State inspector audits facility, equipment, SOPs, and QMS records.
- 04
Query handling
Observations addressed in writing within stipulated time.
- 05
Licence issuance (MD-5 / MD-6)
Licence granted for 5 years (perpetual subject to renewals).
- 06
Post-licence maintenance
Annual self-declarations, batch records, ongoing pharmacovigilance.
Common questions
Typically 4–6 weeks from submission for a clean application. Delays usually come from QMS gaps surfaced during inspection.
Yes, via a variation application. Same class additions are simpler; cross-class additions trigger fresh review.
A licence to manufacture using another licensee's facility. Useful when you have product IP but not your own facility.
Yes — once issued by any State Licensing Authority, an MD-5 covers manufacture and distribution across India.
MD-3 is the application form; MD-5 is the resulting licence.
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