Lifecycle of a Medical Device in India

Overview

The regulatory lifecycle of a medical device in India mirrors the IMDRF Total Product Life Cycle (TPLC) model, adapted to the MDR 2017 framework.

Stage 1 — Design & development

• Establish intended use and classification (Class A, B, C, or D);
• Determine whether device type is notified under Schedule I or Schedule II;
• Initiate risk management per ISO 14971;
• Identify applicable Indian Standards (BIS) and international standards;
• Determine if clinical investigation data will be required.

Stage 2 — Pre-market (import or manufacture)

For importers (overseas manufacturers):

1. Identify Indian Authorised Representative (IAR);
2. Obtain Free Sale Certificate from country of origin;
3. Compile technical documentation (STED format);
4. Submit import licence application via SUGAM portal;
5. Respond to CDSCO queries; receive Form MD-14 (Class B/C/D) or register under Form MD-15 (Class A).

For Indian manufacturers:

1. Apply to SLA (Class A/B) or CDSCO (Class C/D) for manufacturing licence;
2. Undergo GMP inspection;
3. Receive manufacturing licence (Form MD-5 or MD-9).

Stage 3 — Market entry

• Label devices in accordance with Schedule 3;
• Assign UDI (where required for device class);
• Register in the UDID database;
• Distribute through licensed wholesale channels.

Stage 4 — Post-market

• Implement Post-Market Surveillance (PMS) plan;
• Report adverse events and field safety corrective actions via SUGAM vigilance module;
• Submit Periodic Safety Update Reports (PSUR) as required;
• Manage complaints and CAPAs.

Stage 5 — Device changes & licence amendments

• Changes to device design, labelling, or manufacturing site may require amendment of the existing licence;
• Significant changes affecting safety/performance may require new CDSCO submission.

Stage 6 — End of life

• Withdraw device from market; notify CDSCO if required;
• Manage residual vigilance obligations for implantable devices.