Therapeutic Goods Act 1989 / Therapeutic Goods (Medical Devices) Regulations 2002
Australian Medical Devices Regulatory Requirements
Who it’s for
Who should attend
Regulatory affairs and quality staff at manufacturers entering or supplying Australia, Australian sponsors and their regulatory teams, and management responsible for ARTG entries and post-market obligations.
Curriculum
Course modules
- The TGA, the Therapeutic Goods Act 1989 and the Medical Devices Regulations 2002
- Sponsor and manufacturer roles and responsibilities
- Classification rules
- Essential Principles
- Conformity assessment procedures and Australian conformity assessment certification
- Use of overseas evidence: MDSAP certificates and EU conformity assessment documents
- Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 and ISO 13485
- Inclusion in the Australian Register of Therapeutic Goods (ARTG)
- Unique Device Identification: mandatory for Class IIb and Class III from 1 July 2026, the Australian UDI Database (AusUDID), and phased rollout to lower-risk devices
- Advertising requirements and the Therapeutic Goods Advertising Code
- Post-market obligations: adverse event reporting, recalls, Post Market Reviews under section 41JA
- Changing sponsors and maintaining ARTG entries
Outcomes
What you’ll be able to do
- Classify a device under the Australian rules and select the conformity assessment route
- Prepare an ARTG inclusion application
- Understand sponsor obligations after inclusion, including current UDI timelines
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Australian Medical Devices Regulatory Requirements”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.