REGU09004 2019 Global Medical Technology Regulatory Affairs Part 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.

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.

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

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

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

Source and interpret reimbursement requirements

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.

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.

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

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.

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.