Guest Lecture Study Material
"Regulation of Medical Devices in India: Current Framework and Practical Considerations" — Sri Siddhartha Academy of Higher Education.
High-Yield Revision Points
Essential takeaways for the 10-question MCQ assessment
Medical Device Criteria
A product qualifies as a medical device based on its intended medical purpose and physiological mode of action, not on manufacturing origin, price, or electronic status.
Four Risk Classes (MDR 2017)
- Class A: Low risk (thermometers, alcohol swabs).
- Class B: Low-moderate risk (hypodermic needles).
- Class C: Moderate-high risk (ventilators, orthopaedic implants).
- Class D: High risk (pacemakers, coronary stents).
CLA vs SLA Licensing Jurisdiction
Central Licensing Authority (CLA - CDSCO): Commercial imports of all classes; domestic manufacture of Class C & D (Forms MD-7 & MD-9).
State Licensing Authority (SLA): Domestic manufacture of Class A & B (Forms MD-3 & MD-5).
Software as a Medical Device (SaMD)
When mobile software analyzes medical data (e.g. ECG signals) to diagnose or alert about arrhythmia, its clinical intended purpose makes it a regulated medical device.
Post-Market Safety Vigilance
Manufacturers must report recurring safety issues to the licensing authority (MvPI), conduct root cause investigations, implement CAPA, and perform field safety corrective actions if needed.