Licence. Comply. Operate.
India's healthcare and pharmaceutical sector is one of the most heavily regulated. We assist medical device manufacturers, importers, pharmaceutical businesses, healthcare facilities and drug companies in navigating licensing, regulatory compliance and authorisation requirements under CDSCO, the Drugs & Cosmetics Act and related frameworks.
Discuss Your RequirementsApplicable licence by device risk class
| Class | Risk Level | Examples | Applicable Licence |
|---|---|---|---|
| Class A | Low Risk | Tongue depressors, bandages, stethoscopes | MD-3 (Mfg.) / MD-14 (Import) |
| Class B | Low-Moderate Risk | Syringes, BP monitors, simple surgical instruments | MD-5 (Mfg.) / MD-14 (Import) |
| Class C | Moderate-High Risk | Dialysis machines, lung ventilators, implantable devices | MD-7 (Mfg.) / MD-15 (Import) |
| Class D | High Risk | Active implantable devices, cardiac stents, HIV diagnostics | MD-9 (Mfg.) / MD-15 (Import) |
Healthcare & Pharma Compliance Services
Our regulatory pathway assessment, documentation support and application management services help healthcare and pharmaceutical businesses navigate CDSCO licensing and related compliance requirements efficiently.
Medical Device Import Licence
MD-14 / MD-15Importers, authorised agents and foreign manufacturers require a CDSCO import licence (MD-14 for Class A/B devices, MD-15 for Class C/D devices) before importing medical devices into India.
Medical Device Manufacturing Licence
MD-3 / MD-5 / MD-7 / MD-9Indian manufacturers require manufacturing licences under the Medical Devices Rules, 2017: MD-3 and MD-5 for Class A/B devices, and MD-7/MD-9 for Class C/D devices.
Drug Manufacturing & Retail Licence
Manufacturing / Retail / WholesaleBusinesses engaged in manufacturing, wholesale or retail distribution of drugs in India require the applicable licences under the Drugs and Cosmetics Act and Rules.
CDSCO Regulatory Compliance
Post-Market ComplianceOngoing compliance with CDSCO regulatory requirements, including licence maintenance, post-market obligations, surveillance reporting, and regulatory correspondence.
Biomedical Waste (BMW) Authorisation
Healthcare FacilitiesHealthcare establishments, diagnostic centres, pathology labs, blood banks and pharmaceutical companies must obtain BMW authorisation and comply with BMW Management Rules.
Navigate healthcare regulation with confidence
Talk to our team about your CDSCO licensing, drug licence or biomedical compliance requirements.
Get in Touch