Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
CDSCO
Register your medical device in India.
Register your medical device through the CDSCO under the Medical Device Rules 2017, with a dedicated Indian Authorised Agent and risk-based A-D classification.
Speak to a specialistThe authority
Central Drugs Standard Control Organization
CDSCO
Regulatory authority
India
India's national regulatory authority under the Ministry of Health and Family Welfare. It regulates medicines, medical devices and cosmetics under the Drugs and Cosmetics Act. Medical device regulation was modernised through the Medical Device Rules 2017, progressively aligning with IMDRF standards.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class A | Low risk, simplified process | Bandages, gauze, non-surgical masks |
| Class B | Low-to-moderate risk | Diagnostic equipment, contact lenses |
| Class C | Moderate-to-high risk | Infusion pumps, surgical equipment |
| Class D | High risk, requiring intensive clinical review | Cardiac implants, valves, pacemakers |
Registration process
How we manage your project
- 01
Indian Authorised Agent2-3 months
Appoint an Indian authorised agent licensed by the CDSCO (mandatory for foreign manufacturers)
- 02
Classification2-4 weeks
Determine the class (A, B, C or D) under the Medical Device Rules 2017
- 03
ISO 13485 QMS4-8 months
An ISO 13485-certified quality management system, forming the basis for local auditing
- 04
Technical dossier (MD-14/MD-15)3-6 months
Prepare the dossier in English in the CDSCO format
- 05
CDSCO submission6-12 months
Class A/B through the State Licensing Authority; Class C/D through the Central Licensing Authority (CDSCO HQ)
- 06
Inspection (Class C/D)2-4 months
On-site inspection may be required for certain Class C/D devices; issuance of an MD-15 licence
Total timeframeClass A: 4-6 months. Class B: 6-9 months. Class C: 9-15 months. Class D: 12-24+ months
Local representativeIndian Authorised Agent (MD-5 / MD-7 licence)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Materiovigilance Programme of India (MvPI) and adverse event reporting through the CDSCO |
| Renewal | 5 years, renewable with regulatory review |
| Required QMS | ISO 13485 and Indian GMP (Schedule M-III) for local manufacturers |
How HSC helps
India in 6 to 24 months, with a dedicated Authorised Agent and A-D strategy.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about CDSCO
Next step
Ready to start your project in India?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist