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 (22^nd & 29^th September 2024)

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

For Other Nationality: USD 75

Discount: to AMTZ Manufactures; AiMeD Members, UdaiMeD Members, CII Members, ASSOCHAM Members, PWMAI Members & IBSC Partners/Alumni

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

 Last Date for Registration: 21^st September 2023  

For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: +91-8897330990

Email ID: n.nareshkumar@ibsc-amtz.in

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