Tag: Medical Devices Rules 2017

Industry Update – Standard IVD Evalution protocols

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Standard IVD Evaluation Protocols –
Drafted by ICMR and CDSCO

Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly issued the Draft Standard IVD Evaluation Protocols

The document outlines the need for standardized evaluation protocols for IVDs as mandated by the Medical Devices Rules 2017. These protocols are essential to ensure the quality and performance of diagnostic kits used in India

Several specific performance evaluation protocols have been drafted, including those for:

a. Chikungunya IgM ELISA
b. Dengue NS1 RDT and ELISA
c. Zika virus real-time PCR , among others

The document includes detailed guidelines for evaluating various IVDs, emphasizing:

i. Study design and ethical considerations
ii.Requirements for evaluation sites and laboratory standards
iii.Procedures for conducting diagnostic accuracy studies
iv.Acceptance criteria for sensitivity and specificity of tests.

This initiative by ICMR and CDSCO aims to enhance the reliability of diagnostic testing in India through structured evaluation processes, ensuring that manufacturers adhere to high standards of quality in their products. Stakeholder engagement is critical to refining these protocols before their final adoption.

Stakeholders are invited to provide comments on these protocols until February 15, 2025.

Comments should be submitted via email before 15th February 2025, at ivdevaluation@gmail.com as per the specified format given in the notification

Click here to read IVD protocols

Source: https://www.icmr.gov.in/icmrobject/uploads/WhatsNew/1735801120_advt_ivd_document.pdf

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

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Workshop on Indian Medical Device Rules 2017

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

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (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
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

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

Duration: 2 Days (31st March & 1st April)

Location: Kalam Convention Center, AMTZ Campus, Vizag

Fee: INR 3,540 (Including GST)

Registration link: https://ibsc-amtz.in/coursedetails/25

Last Date For Registration: 25th March 2023
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For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990
WhatsApp Link: https://wa.me/918897330990
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

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