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INDIAN- MEDICAL DEVICE REGULATIONS TRAINING PROGRAM

Indian Medical Device Regulations training program ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.

ADMISSIONs OPEN

INDIAN- MEDICAL DEVICE REGULATIONs TRAINING PROGRAM

LEARNING OBJECTIVE

Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulation (IMDR)
Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulation (MDR)

To understand the responsibilities and obligations as a manufacturer, importers and distributers of medical devices

COURSE AGENDA

· Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)

· Classification of Medical Devices

· Basic Requirements

· Content Requirements for Technical Documentation

· Scrutiny Procedure

· Validity of Conformity Assessment and Certification, Transition Periods

· Requirements for Manufacturers, Importers, Distributors and Service Partners

· Role of Contact Person for Regulatory Compliance

TARGET AUDIENCE

Medical device manufacturers
Consultants
Regulatory Affairs Specialists
Expert advisors in medical devices regulatory affairs
Working biomedical engineers / medical device professionals
Pursuing Students are also eligible

Training Duration: 2 Days (14th & 15th June 2025)

Course Fee: For Indians INR 3,540 (including GST)

For Other Nationality: USD 100

Certificate will be provided to each participant upon successful completion of the training.

Last Date for Registration: 14th June 2025

For more information, please contact

Ms Durgankitha,

Scientist, IBSC

9985001873

durgankitha.k@amtz.in

For payment scan this QR code and pay and whatsapp the payment screenshot to 9985001873 or 8897330990

Course Fee Information
S.No	Start Date	End Date	Total Amount (INDIA)	Total Amount (Foriegn)
1	2025-06-08	2025-08-31	3,540	8,500

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