Glossary of Key Terms
| Term | Definition |
|---|---|
| CDSCO | Central Drugs Standard Control Organisation — India's national medical device and drug regulator |
| CLA | Central Licensing Authority — the DCGI acting in the capacity of granting central licences |
| D&C Act | Drugs and Cosmetics Act 1940 — the primary legislation for drugs, devices, and cosmetics in India |
| DCGI | Drugs Controller General of India — head of CDSCO and Central Licensing Authority |
| FSCA | Field Safety Corrective Action — action taken to reduce risk of serious injury from a device already on the market |
| FSN | Field Safety Notice — communication to customers/users about a safety issue |
| FSC | Free Sale Certificate — document from the competent authority of the country of manufacture confirming the device is legally sold there |
| GMP | Good Manufacturing Practice — quality system requirements under Schedule 5 of MDR 2017 |
| IAR | Indian Authorised Representative — entity in India legally responsible for import compliance on behalf of a foreign manufacturer |
| ICMED | India Certification of Medical Devices — India-specific QMS certification scheme |
| IVD | In Vitro Diagnostic — device used to examine specimens derived from the human body |
| MDR 2017 | Medical Devices Rules 2017 — the principal subordinate legislation for medical device regulation in India |
| MDVP | Medical Device Vigilance Programme — CDSCO's post-market safety monitoring programme |
| ND&CT Rules | New Drugs and Clinical Trials Rules 2019 — governs clinical investigations for new devices |
| PLI | Production Linked Incentive — Government of India scheme to incentivise domestic manufacturing |
| PMS | Post-Market Surveillance — systematic collection and analysis of post-market device data |
| PMSR | Post-Market Surveillance Report |
| PSUR | Periodic Safety Update Report |
| QCO | Quality Control Order — mandatory BIS certification order for specified device categories |
| SaMD | Software as a Medical Device |
| SLA | State Licensing Authority — state-level authority licensing Class A/B manufacturers and wholesale/retail dealers |
| STED | Summary Technical Documentation — IMDRF-aligned format for technical documentation |
| SUGAM | CDSCO's online portal for submission of licence applications and vigilance reports |
| UDI | Unique Device Identification — system for unambiguous device identification |
| UDID | Unique Device Identification Database — India's national UDI registry |
PMSR: Post-Market Surveillance Report — periodic report documenting post-market data collected under a Post-Market Surveillance Plan, submitted to CDSCO to demonstrate ongoing device safety and performance.