Full Title Global Medical Technology Regulatory Affairs Part 1

Short Title Global MedTech Part 1

Code REGU09004
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

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. It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.

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. 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 submission types involved by completion of mock technical documentation from classification through to commercialization.

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

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.

  2. Identify key differences between these regulatory systems and that of the EU and US and outline methodology 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,directives and legislation currently regulating medical device classification 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


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

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 3,4,5,6 60 Week 7
Case Study workshop scenarios (formative) 4,5 20 Week 12
LAQ 1,2,3 20 Week 3


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
Url Resources
http://www.raps.org/store/fundamentals/



http://www.globalregulatorypress.com/

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

ISBN BookList

Book Cover Book Details
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164