Description
Gaining access to the Australian medical device market requires compliance with the Therapeutic Goods Administration (TGA) regulations under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. The TGA medical device approval process involves determining device classification, selecting the correct conformity assessment pathway, and ensuring compliance with the Australian Register of Therapeutic Goods (ARTG) requirements.
SOP-REG-004: Medical Device Marketing Authorization in Australia provides a structured step-by-step frameworkfor manufacturers, sponsors, and regulatory professionals navigating the TGA approval process. This SOP ensures full compliance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and Australian conformity assessment procedures, allowing companies to accelerate approval timelines and meet post-market surveillance requirements.
Why You Need This SOP
Navigating TGA medical device approval can be challenging, with strict regulatory requirements and multiple conformity assessment routes. Without a clear regulatory strategy, companies risk delays, rejected applications, and compliance issues. This SOP simplifies the process by providing a structured regulatory roadmap to:
🔹 Determine the correct classification and regulatory pathway under TGA regulations.
🔹 Prepare and submit applications for ARTG inclusion efficiently.
🔹 Ensure compliance with ISO 13485:2016 and MDSAP for a smoother approval process.
🔹 Streamline conformity assessments for faster access to the Australian market.
🔹 Meet TGA’s post-market obligations, including recalls, adverse event reporting, and audits.
Who Should Buy This SOP?
This SOP is a must-have regulatory tool for companies looking to enter or expand in the Australian medical device market. It is ideal for:
✔ Medical Device Manufacturers applying for ARTG inclusion.
✔ Regulatory Affairs Professionals managing TGA submissions.
✔ Sponsors & Distributors responsible for ensuring regulatory compliance.
✔ Consultants & Advisors assisting companies with TGA approval.
✔ Startups & SMEs needing a structured and cost-effective regulatory approach.
Why Choose This SOP?
SOP-REG-004: Medical Device Marketing Authorization in Australia is fully compliant with TGA and ISO 13485 requirements, integrating MDSAP best practices for a smoother, faster approval process. This SOP will help you:
✔ Eliminate uncertainty by providing a structured regulatory roadmap.
✔ Avoid application rejections by ensuring accurate, complete submissions.
✔ Reduce costs and speed up approvals by leveraging international regulatory certifications.
✔ Ensure full post-market compliance, avoiding penalties and product recalls.
✔ Gain market access faster with a proven step-by-step regulatory strategy.
