REGU08007 2017 Fundamentals of Global Medical Device Regulations

General Details

Full Title
Fundamentals of Global Medical Device Regulations
Transcript Title
Global Med Dev Regs
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

This module aims to provide students with an introduction to and a fundamental understanding of applicable legislation to medical devices in key markets outside EU and US such as Canada, Australia, Japan and emerging markets. The module will provide students with an understanding of the semantics of each classification system and potential regulatory pathways for placing medical devices on the market in global markets. The module will outline and the legal basis for the use of a Notary Public and documents such as Certs of Free Sale, legalised and consularised documentation.

Learning Outcomes

On completion of this module the learner will/should be able to;


Explain the reason for use of The Hague Convention, Notary Public, Legalisation and Consularisation of documentation


Demonstrate an understanding of the basics of applicable legislation in each market


Classify a medical device under each market


Demonstrate an understanding of each regulatory system such that one can facilitate regulatory submissions in each market


Navigate basic change control principles for each market


Demonstrate an understanding of the outline of the STED document and the function of the IMDRF

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: 

  • The Hague Convention, Notary Public, Legalization and Consularisation of documentation
  • Outline of key legislation, regulatory bodies and definition of a medical device in each identified market
  • How to determine device classification in each market and approximate timelines for regulatory approval
  • Medical Device registration and licensing requirements in the applicable markets
  • When you need to include an in-country agent and key watch outs
  • Basic change control principles
  • STED Format
  • Post Market requirements

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 20 % Week 3 1,3,6
2 Essay Continuous Assessment Essay 30 % Week 6 2,3,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 15 % Week 10 4,5
4 Critical evaluation Continuous Assessment Written Report 25 % Week 8 4,6
5 Presentation Continuous Assessment Oral Exam 10 % Week 13 3,6

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2013-03-27 Handbook of Medical Device Regulatory Affairs in Asia Pan Stanford

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors.

Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Recommended Reading
2015-08-03 Medical Device Regulatory Practices: An International Perspective Pan Stanford

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success.

Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Module Resources

Non ISBN Literary Resources

as per booklist

URL Resources