NIHFW

Preparedness for Transition to Licensing Under Medical Devices Rules (MDR)

Enroll Now

12 Students

No Instructor(s)

Lesson 1 - Overview of the Regulatory Framework of Medical Device and IVDs

PDF
Lesson 2 - BIS Activities on Medical Devices

PDF
Lesson 3 - Materiovigilance Programme of India (MvPI): An Overview

PDF
Lesson 4 - IndiaPerformance Evaluation/ Clinical Performance Evaluation of In-Vitro Diagnostic Kits

PDF
Lesson 5 - Introduction to Medical Device Risk Classification

PDF
Lesson 6 - Design Controls for Medical Devices

PDF
Lesson 7 - Medical Device Risk Management

PDF
Lesson 8 - Quality Management Systems

PDF
Lesson 9 - Testing and Certification of Medical Devices

PDF
Lesson 10 - Transition: Licensing on Sugam Portal

PDF
Lesson 11 - Transition: Licensing in Online Portal

PDF
Lesson 12 - Regulatory Requirements on IVD Instruments/Analyzers and IVD Software

PDF
Lesson 13 - IVD Stability Studies: An Overview

12 CDSCO Capacity Building Training
Assessment

Check Your Knowledge
Discussion Forum

Discussion Forum
Feedback

Feedback
Certificate

Preparedness for Transition to Licensing Under Medical Devices Rules (MDR) (Certificate)