TypeOnline Course
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Medical Devices Regulation





This training course imparts knowledge and practical understanding about the Medical Devices types, regulatory overview and approval process.

Course Code: KPE-C-018

Course Title: KPE’s Certificate Course in Medical Device Regulations.

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulations and approval process in details. The course is designed to challenge 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.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a medical devices company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on Medical devices industry
  • Anyone who want to know / update about the Medical Devices Business Management / Strategic Planning

1. Orientation to practical understanding Medical Devices classifications and understanding of the regulatory approval process.

2. Simulation to real life Strategic planning in medical devices management – premarket and post market.

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Month 

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to know or upgrade their knowledge about medical devices regulation, can pursue the course.

Section 1US Medical Devices
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Medical Devices Work File
Lecture 5Review Test
Section 2510k Pre-market Notification
Lecture 6Overall Understanding 510k - Pre-market Notification
Lecture 7Predicate Devices | Substantially Equivalent (SE) |Types of 510(k)s
Lecture 8Understanding on 510k | Types of the 510k | Timeline | Difference with PMAFDA 510(k) Step By Step - Decision Making process
Lecture 9FDA decision making process for different classes of 510k applications
Lecture 10Review Test
Section 3Premarket approval (PMA) application
Lecture 11What is Premarket approval (PMA) application?
Lecture 12Differences between 510k VS. PMA
Lecture 13Data Requirements for A Premarket Approval (PMA) application | Dossier Template | FDA action plan post submission of the PMA application
Lecture 14PMA - Quality System
Lecture 15Labeling Requirements
Lecture 16Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 17PMA Postapproval Requirements
Lecture 18Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 19Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 20Expedited Review of PMA application
Lecture 21Expiration Dates
Lecture 22Device Master Files
Lecture 23Unapproved use of Medical Devices 
Lecture 24Marketing, Advertising and Promotion of Medical Devices
Lecture 25Significance of Submitting a FDA 513(g)
Lecture 26DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 27Humanitarian Device Exemption (HDE)
Section 4Combination Products
Lecture 28Definition of combination products
Lecture 29Examples of Combination Products
Lecture 30Premarket Review and Postmarket Regulation of Combination Products
Section 5Medical Devices Regulation in Canada
Section 6EU Regulation for medical devices
Lecture 32Medical Devices: EU Directives, Classification and Guidance, CE Marking.
Lecture 33EU Medical Devices Regulation - New Updates
Section 7QMS for Medical Devices
Section 8c-GMP Requirement for Medical Devices
Lecture 35c-GMP Requirement for Medical Devices
Lecture 36Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 37Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 38Documentation | Good Documentation Practices
Lecture 39Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Section 9Medical Devices Regulation in India
Section 10CE Marking
Lecture 41Introduction to CE Marking
Lecture 42CE- Self Certification
Lecture 43General principles of the CE marking
Lecture 44Manufacturer Responsibilities
Lecture 45Third Party Medical Device Manufacturing & CE Marking
Lecture 46Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 47Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 48Step By Step CE Marking Process
Lecture 49Case Study
Section 11Technical Dossier
Lecture 50Introduction to Medical Devices Technical Documentation
Lecture 51Components of technical documentations
Lecture 52Technical Dossier - Information Required
Section 12ISO 13485:2016 : Implementation in Medical Device Organization
Lecture 53Introduction to ISO 13485:2016
Lecture 54 ISO 13485:2016 Audit Checklist
Section 13Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 14Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 15Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Section 16Final Examination
Lecture 58Registration for final examination
Lecture 59Final Examination