Regulation of Medical Devices in India: Current Framework and Practical Considerations
Organized by Sri Siddhartha Academy of Higher Education. Explore Indian Medical Device Rules (MDR 2017), risk classifications, CLA/SLA licensing, software as a medical device (SaMD), and post-market safety.
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With Warm Regards & Patronage
Under the visionary guidance of Sri Siddhartha Academy of Higher Education leadership
Dr. K B Lingegowda
Sri Siddhartha Academy of Higher Education, Tumkur
Dr. Ashok Mehatha
Sri Siddhartha Academy of Higher Education, Tumkur
What You Will Learn & Be Evaluated On
The objective assessment covers both foundational principles (Pre-Lecture) and practical regulatory workflows (Post-Lecture).
1. Medical Device Classification
Mode of action vs pharmacology, and the 4 principal risk classes under MDR 2017: Class A (Low Risk), Class B (Low-moderate), Class C (Moderate-high), and Class D (High).
2. Licensing Authorities & Forms
Jurisdiction of Central Licensing Authority (CLA) vs State Licensing Authority (SLA), import licences, Form MD-7 and Form MD-9 for Class C manufacture.
3. SaMD & Post-Market Safety
Software as a Medical Device (diagnostic mobile apps), ISO 13485 QMS consistency, Materiovigilance, adverse event reporting, and CAPA.
How It Works
Follow these simple steps from registration to downloading your official certificate.
Online Registration
Provide name, department, and roll number to generate your Exam ID.
Study Material
Download the reference PDF notes on Indian Medical Device Regulations.
MCQ Assessment
Take the timed 10-question assessment with auto-saved responses.
Submit Feedback
Rate the lecture sessions and share your valuable academic feedback.
Get Certificate
Download your high-res verifiable Certificate with QR code & score.