Country Regulations: India

This module will provide a broad overview of how local regulations are evolving in the context of changing global landscape; and give you an overview of Classifications system, regulatory pathways and product registration of MDs and IVDs in India.

English

100% Online

60 Minutes

APACMed Certificate

Assessments

Interactive

About the Regulatory Affairs eLearning Program

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This module has been developed by:

Sahjogita Kathuria
Director Regulatory Affairs & Quality Assurance
Terumo India Pvt .

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will provide a broad overview of how local regulations are evolving in the context of changing global landscape; and give you an overview of Classifications system, regulatory pathways and product registration of MDs and IVDs.

Who should enrol in this Module? 

This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices in India.

How is this Module structured?

This is a self-paced, interactive Module.  It is divided into a number of individual topics so you can easily track your progress and manage your time.

You must watch all of the videos and presentations before the section will be marked as complete.


You can view the structure and individual topics below.

What kind of assessment do I need to do?

This Module contains a number of short knowledge checks and a final assessment.  They are a combination of multiple choice and role play scenarios.

You will have unlimited attempts to pass each knowledge check.

What will I learn?

By the end of this module, you will have an understanding of:
  • The Indian Regulatory System & Regulatory environment with a focus on medical devices
  • The Medical Devices Rules 2017
  • The definitions, classification and grouping of medical devices in India
  • The Medical Devices Amendment 2020 and its impact
  • The key requirements for product registration in India

When will I get my certificate?

At the completion of the course you will immediately have access to the certificate from APACMed.