InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$180 / 9000 INR.
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medical device regulation in india

Introduction

Who should attend

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
  • Title of the course: Competency Development Training in Medical Device Regulation in India.
  • Duration: 1 Week /  7 days.
  • Nature of training: Online self paced learning.
  • Certification: Course certificate will be provided at the end of the course.

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.
  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
  • Drug + Medical Device Regulatory Affairs (Dual Specialization) >> Click here
Section 1Advanced Understanding on Indian Medical Devices Regulation
Lecture 1Medical Device Regulation in India | Overall understanding
Lecture 2Regulatory Landscape in India
Lecture 3Classification of the Medical Devices in India | Strategic Planning for the Submission 
Lecture 4Notified and Non-notified Device | Submission Strategic Planning 
Lecture 5Medical Devices Classification in India - Work Doc
Lecture 6Notified Devices | Registration Process
Lecture 7Medical Device Submission Strategic Pathways | Step by step Process 
Lecture 8Medical Device Forms | Purposes
Lecture 9Non Regulatory Medical Devices
Lecture 10Medical Device Voluntary Registration | Documentation | Process
Lecture 11List of Notified Devices | Newly Notified Devices | Significance
Lecture 12List of Notified Bodies with CDSCO
Section 2Export Requirements
Lecture 13Overview of US Medical Devices Market
Lecture 14Classification of Medical Devices
Lecture 15Medical Devices Classification : Work File 
Lecture 16Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 17510k - Pre-market Notification
Lecture 18Predicate Devices | Substantially Equivalent (SE)
Lecture 19Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 20Premarket approval (PMA) application
Lecture 21Medical Devices: EU Directives, Classification and Guidance, CE Marking.
Lecture 22Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 3Labeling
Lecture 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 24Instruction for Use (IFU) | Design and Development of IFU 
Lecture 25UDI | Different Component | How to design  
Lecture 26Implant Card | Regulatory Importance | Content | How to design 
Section 4Documentation and Technical Files Preparation
Lecture 27Medical Device Technical File
Lecture 28Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 29Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 30Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 31Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 32CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities |  Third Party Medical Device Manufacturing & CE Marking |  Step By Step CE Marking Process