InstructorRoyed Training
TypeOnline Course
Price$180 / 9000 INR.
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medical device regulation in india

Introduction

Who should attend

Course Type

Duration

Eligibility

Certification

Course Deliverable

Features

Related Courses

training on medical device regulation in India

This Course imparts knowledge and practical skills about the Regulation, Registration and approval process in India. This advanced certification course in Medical Devices also covers medical devices strategic management and planning process. Hence, this course will demonstrate medical devices business skills  and concepts to handle the medical devices business for India. The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Moreover, cutting edge simulations help participants apply the knowledge in interactive real life simulation.

Therefore, this online training course provides provide medical devices submission process for India. Also at the same time, course provided advanced insight on various pathways for medical devices approval based on the class of the medical devices.

In addition, this course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure. 

Moreover, user can access the course at own pace. It allows the user to stop and start at their leisure. 

Course Code: RYD-087

Course Title: Competency Development Training in Medical Device Regulation in India

Who should attend?

  • This course is ideal for Medical Devices Professionals handling registration submission in India.
  • In fact, the course suits to those who are seeking to improve their skills in the medical device regulatory environment specific to India.
  • Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
  • Anyone wishing to update their knowledge on registration in various across different regulatory bodies.
  • Those who are working in  Business Development and Strategic Planning department.
  • Most importantly, this course suits to medical devices regulatory professionals who are handling Indian market.

Online distance learning course. Course can be accessed online across anywhere 24×7.

This training course is for 1 week. One can complete anytime during this 7 days tenure.

Graduation in any discipline.

Certificate will be provided at the end of the successful completion of the course

  1. Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also be eligible to receive the course study modules, which you can download by login to your course page.

Course Features

This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of medical device regulation and approval process in India. The course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Important Learning Features: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • The course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
  • Interactive E-lectures helps user to understand of the concepts effectively.
  • Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.

Course Coverage Area

  • The course provided comprehensive advanced understanding on Indian medical device regulation.
  • Advance practical training in premarket approval process for India.
  • Advance training on technical dossier preparation.
  • Detailed training on ISO 13485 and CE certification process.
  • Training on Medical device technical dossier preparation.

Related Courses

Followings are the few of the similar courses, you may be interested in

  • US Medical Devices Regulation >> Click here
  • Drug Regulatory Affairs Course >> Click here
  • Online Training on CE certification >> Click here
  • Medical devices regulatory affairs >> Click here
  • Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
  • USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> Click here
Section 1Advanced Understanding on Indian Medical Devices Regulation
Lecture 1Indian Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Examples of Medical Devices
Section 2Pre Market Approval Process
Lecture 5Overall Understanding
Lecture 6Predicate Devices | Substantially Equivalent (SE)
Lecture 7Review Test
Section 3QMS FOR MEDICAL DEVICES
Section 4C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 9c-GMP Requirement for Medical Devices
Lecture 10Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 11Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 12Documentation | Good Documentation Practices
Lecture 13Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Section 5CE MARKING : Detailed Training
Lecture 14Introduction to CE Marking
Lecture 15CE- Self Certification
Lecture 16General principles of the CE marking
Lecture 17Manufacturer Responsibilities
Lecture 18Third Party Medical Device Manufacturing & CE Marking
Lecture 19Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 20Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 21Step By Step CE Marking Process
Lecture 22Case Study
Section 6TECHNICAL DOSSIER
Lecture 23Introduction
Lecture 24Components of technical documentations
Lecture 25Technical Dossier - Information Required
Section 7ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 26Introduction to ISO 13485:2016
Lecture 27ISO 13485:2016 Audit Checklist