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 (22nd & 29th 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: 21st September 2023  

FOR QUOTATION SEND EMAIL TO n.nareshkumar@ibsc-amtz.in


For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: +91-8897330990

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


Course Fee Information

S.No Start Date End Date Total Amount (INDIA) Total Amount (Foriegn)
1 2024-11-01 2024-12-31 3,540 6,000

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