ARCS Australia

Introduction to Regulatory Affairs of Medical Devices

Start Date: 16 March 2026
End Date: 16 March 2026
Start Time: 09:00
End Time: 17:00
Venue: ARCS Virtual Classroom
Who Can Register?: Anyone

Workshop overview

The role of the regulatory affairs professional working or aspiring to work in the medical device/medical technology sector is increasingly challenging with the rapidly changing technology and a constant shift in global regulations. This one (1) day entry level course provides a comprehensive overview of the regulation. It is delivered as a virtual workshop with interactive and real-life examples to illustrate and support the course material.

You can expect to gain in confidence as a regulatory professional and the course will provide foundation knowledge to progress your career. You shall find it informative, challenging, and entertaining.

Who should attend

Junior regulatory professionals already in the industry (less than 12 months experience) with a desire for a refresher course including current updates.
Anyone aspiring to take on the role of a regulatory professional in the medical device sector
Industry professionals working in cross functional roles needing to better understand the regulatory process
Industry professionals with a pharmaceutical background with an expanding responsibility for medical devices/IVDs, combination products and system packs
This course is also ideal for university/PhD graduates working in a university, a spin-off company or in a start-up environment.

Learning objectives

By the end of this workshop, attendees should be able to:

Appreciate the Australian regulatory environment, including the objectives of the Therapeutic Goods Act and the role of the Therapeutic Goods Administration (TGA) in the pre- and post-marketing phases of a medical device’s life cycle
Compare and contrast regulations in Australia to Europe and the United States of America
Explain the different kinds of medical devices and interpret the classification rules
Differentiate the regulatory responsibilities of the sponsor and manufacturer in the pre- and post-market phases
Discuss the essential principles and identify those that apply to different medical devices
Determine conformity assessment pathways, including the roles of a notified body
Compare the use of ISO 13485 versus Medical Device Single Audit Program (MDSAP) as manufacture’s evidence
Lodge a medical device application with the TGA and understand the types of application audits that may be called by the TGA
Describe the regulation of contemporary devices such as software, AI and custom (3D printed) products
Apply clinical evidence requirements
Describe the skills and behaviours which make a medical device regulatory professional successful in the wider project team

Speaker Bio

Arsh Ramana

Manager, Regulatory Affairs & Quality, STERIS ANZ & SEA |Medical Devices | Strategic Integration Expert

Arsh Ramana is an accomplished Regulatory and Quality Affairs professional with extensive experience across the ANZ, SEA and India regions in the medical devices industry. With a strong foundation in compliance, quality systems, and regulatory strategy, Arsh has successfully led and supported complex regulatory landscapes and quality operations for global medtech organizations.

Her career spans pivotal roles in high-impact corporate transitions, including acquisitions and divestitures such as:

Medtronic–Covidien and Medtronic–Cardinal Health, where she played a key role in regulatory integration and quality harmonization.

O&M Halyard–Avanos, contributing to post-acquisition regulatory alignment and quality system transformation.

Fortive–ASP, establishing the regulatory & quality functions in ANZ & India after ASP was divested by J&J and acquired by Fortive.

STERIS, where she was instrumental in establishing STERIS’ regulatory and quality functions supporting direct footprint of STERIS in Australia and New Zealand, while navigating multiple acquisitions in STERIS to expand its regional presence.

Arsh is known for her strategic foresight, cross-functional leadership, and ability to drive regulatory excellence during periods of organizational change. Her contributions have consistently ensured business continuity, regulatory compliance, and quality system robustness in dynamic environments as per ISO9001 as well as ISO13485.

She is passionate about advancing regulatory and quality compliance in the medtech sector and actively engages with professional networks to foster innovation and collaboration.

Continuing Professional Development (CPD) points

Upon completion of this workshop, attendees will receive 7 CPD points

Entry criteria

The workshop is open to everyone with an interest in the regulation of medical devices.

Preferably, participants hold relevant tertiary qualifications in one of the following disciplines: physics, chemistry, electrical/biomedical/mechanical or related engineering.

As the course is delivered in English, proficiency is assumed.

Registration fees

Workshop fees (incl. GST):

ARCS member - $805
Non-member - $1285

Registration terms and conditions

Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.

Virtual classroom

This workshop runs from 09:00-17:00 AEST

Attendee requirements:

Computer/laptop connected to power
Good internet access (1Mbps or better – broadband recommended)
A charged mobile phone and headphones (if using your phone for audio)
Phone charger – given the event goes all day, you will need a way of charging your phone
Headphones for computer audio (if using computer audio)
A quiet room/space

Testimonials

"Very good course that has provided me with reinforced confidence with medical device registration as well as provide new information/learning for areas I have not yet had an opportunity to work on. The facilitator was well paced with the information and was able to respond to all questions immediately, or investigated a response during breaks. It was great to have a well informed and experienced professional running the course." Regulatory Affairs Manager, Guerbet Australia.