Licensing medical devices and IVDs in India, and taking Indian devices global.
For Indian manufacturers moving to higher-risk devices and international markets, and for overseas companies entering India.
Key facts
Pathways
- Manufacturing licence: MD-5 for Class A and B from the State Licensing Authority, MD-9 for Class C and D from the Central Licensing Authority
- Import licence MD-15 from the Central Licensing Authority
- Test licences for devices made or imported for testing and evaluation
- Permission for clinical investigation or clinical performance evaluation of new devices
What you will need
- Device Master File and Plant Master File (Fourth Schedule)
- QMS evidence to the Fifth Schedule
- Free sale certificate from the country of origin for imported devices
- Labelling to the Medical Devices Rules
Sequence and decision points
- 01ClassifyApply the risk classification and CDSCO classification lists.
- 02Prepare filesDevice Master File, Plant Master File and QMS evidence.
- 03Apply onlineSubmit through the CDSCO online system with fees.
- 04Audit or inspectionNotified body audit (A, B) or CDSCO inspection (C, D).
- 05LicenceLicence granted; retention fee paid every five years.
Fifth Schedule QMS requirements, aligned with ISO 13485. Class A and B sites are audited by notified bodies registered with CDSCO; Class C and D sites are inspected by CDSCO.
Overseas manufacturers apply through an Indian authorised agent holding a manufacturing or wholesale licence.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Licence fees are set in the Second Schedule. Licences remain valid while the retention fee is paid every five years. Review times vary by class and authority.
After market entry
- Adverse event reporting under the Materiovigilance Programme of India
- Recalls and field safety notices
- Post-approval change notifications and approvals
- Licence retention every five years
How we help
- Classification and licensing strategy
- Device Master File and Plant Master File preparation
- Fifth Schedule and ISO 13485 QMS
- Import licence support with your authorised agent
- Clinical investigation permissions
- India to global: CE marking and FDA strategy for Indian manufacturers
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about India
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Does every device need a licence?
Licensing now covers all risk classes, with specific provisions for some low-risk devices. Confirm your device's class and status first.
Who can act as our authorised agent?
An Indian entity holding a manufacturing or wholesale licence. We coordinate with your agent or help you appoint one.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.