REGU09004 2019 Global Medical Technology Regulatory Affairs Part 1

General Details

Full Title
Global Medical Technology Regulatory Affairs Part 1
Transcript Title
Global Medical Technology Regu
Code
REGU09004
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology Regulatory Affairs
Description

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market outside of the US and EU, specifically Russia/CiS; Brazil/Latin America; Canada/Australia and New Zealand. It explains the legislation applicable and guidelines available to medical device manufacturers.

 

Learning Outcomes

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

1.

Demonstrate they have detailed knowledge and understanding of the administrative and legislative structure and requirements for medical devices in key global markets to include Russia/CIS; Brazil/Latin America; Canada/Australia and New Zealand.

2.

Identify key differences between these regulatory systems and that of the EU and US and outline methodologies to ensure a device can utilize key documentation from EU and US applications in achieving market approval in the above defined jurisdictions.

3.

Critique guidances, regulations and legislation currently regulating medical device classification (as applicable ) within these global markets and demonstrate ability to classify devices appropriately.

4.

Articulate an understanding of how to define the regulatory pathway for medical devices in these global markets including complex combination or novel devices.

5.

Demonstrate they have detailed knowledge and understanding of how to manage change control from a global point of view.

6.

Source and interpret reimbursement requirements

7.

Understand International Law norms such as Notary Public, Apostille, Legalisation, Certificates of Free Sale, and Certificates of Free Goods. Understand the function of the Foreign Office etc.

Teaching and Learning Strategies

The educational elements will be provided by the Institute of Technology Sligo and NUI Galway  staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

Module Assessment Strategies

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

Repeat Assessments

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: Global institutions in key markets such as Russia/CiS; Brazil/Latin America; Canada/Australia and New Zealand. Regulatory pathway; Classification; Standards; Post market surveillance requirements; market clearance. 

Demonstrate they have detailed knowledge and understanding of how to achieve market clearance/approval for a medical device destined for a global marketplace and how to address post market surveillance requirements once a product is placed on the market. 

Demonstrate they have detailed knowledge and understanding of the complexities of regulatory strategy within global markets and understand the submission types involved through a series of appropriate assessments covering each geographical region. 

Formulate and communicate judgements with regard to regulatory issues for devices such as country specific nuances connected with entry/exit from each country and demonstrate ability to interact effectively with appropriate authorities. 

Source and interpret local global market standards.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment written assignment Continuous Assessment Assignment 50 % Week 12 1,2,3,4,5,6,7
2 Case Study change control essay questions (formative) Continuous Assessment Assessment 30 % Week 10 1,2,3,4,5
3 MCQ Continuous Assessment Open Book Exam 15 % Week 6 1,2,3,7
4 classification- short essay questions Continuous Assessment Open Book Exam 15 % Week 5 1,3,4

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

Module Resources

Non ISBN Literary Resources

http://www.raps.org/store/fundamentals/ 



http://www.globalregulatorypress.com/ 

https://www.crcpress.com/product/isbn/9789814411219

Journal Resources

http://www.raps.org/store/fundamentals/ 



http://www.globalregulatorypress.com/ 

https://www.crcpress.com/product/isbn/9789814411219

URL Resources

 

http://www.raps.org/store/fundamentals/ 
Irish Foreign Office and HPRA link re international laws and documentation available

Health Canada links
TGA links (Australia)

RZN links (Russia)

Medsafe links (New Zealand)
CIS links

Anvisa Links (Brazil)

COFEPRIS links (Mexico)

Anmat links (Argentina)

INVIMA links (Colombia)

Appropriate Blogs, webinars and white papers

MDSAP links
http://www.globalregulatorypress.com/ 

https://www.crcpress.com/product/isbn/9789814411219

Other Resources

None

Additional Information

None