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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; upon approval receive Form MD-14 import licence (Class B/C/D) or Form MD-15 registration certificate (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.

Form MD-14 is the import licence application form for Class B, C, and D devices; Form MD-15 is the registration form for Class A devices, which requires registration rather than full licensing.

Schedule I contains most medical devices; Schedule II contains in vitro diagnostic (IVD) devices. Classification as Class A, B, C, or D determines the licensing pathway, not the schedule.

For Class A devices under Form MD-15: Submit registration documentation via SUGAM portal; no GMP inspection required prior to registration; devices may be imported and sold upon registration approval. For Class B, C, D devices under Form MD-14: Submit licence application via SUGAM portal; undergo CDSCO technical review and may require notified laboratory testing; GMP inspection conducted before licence issuance.

PSURs are typically submitted annually or at intervals specified in the import/manufacturing licence conditions. Initial PSUR is due one year after initial supply; subsequent reports follow annually or as directed by CDSCO. Class A devices may have different or no PSUR requirements depending on risk classification.