Regulatory Compliance in Australia
Medical Device Registration in Australia
Australia’s healthcare market offers significant opportunities for innovative medical devices, supported by a regulatory framework that prioritizes safety and performance. However, the journey to compliance with the Therapeutic Goods Act 1989 can be complex, requiring precision and expertise to meet the strict standards of the Therapeutic Goods Administration (TGA).
To list your device in the Australian Register of Therapeutic Goods (ARTG), it must meet strict safety and performance criteria. For international manufacturers, Australia’s acceptance of EU and US regulatory approvals simplifies the process, but navigating the local requirements—such as gap assessments and quality management systems—remains a critical step.
At Qserve, we provide comprehensive support to help you bring your medical devices to the Australian market with confidence. Our team of regulatory specialists combines deep knowledge of TGA standards with practical, step-by-step guidance to streamline your registration process.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with Medical Device Registration in Australia or go-to-market strategy?
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Why Partner with Qserve for Your Regulatory Needs?
Worldwide support
When navigating the complex world of medical devices and in vitro diagnostic (IVD) regulations, Qserve stands out as a trusted partner. We combine global expertise with a hands-on approach to help manufacturers achieve and maintain market access efficiently and effectively.
Trusted Global Regulatory Expertise
With a presence worldwide, Qserve has extensive experience in diverse regulatory environments. Our team of seasoned regulatory and quality affairs experts understands the unique challenges of each market, offering solutions tailored to your specific needs. Whether going to new markets or maintaining compliance with existing ones, our worldwide reach ensures you're supported.
Practical, Step-by-Step Support
Navigating regulations can be overwhelming. That breaks down the process into clear, actionable steps. From regulatory strategy to post-market surveillance, we work alongside you to ensure every detail is addressed. Our focus on practical solutions means less complexity for you and faster results for your business.
Proven Track Record of Success
Qserve has helped countless manufacturers successfully navigate the regulatory landscape. From startups to established global companies, we have the expertise to handle projects of all sizes and complexities, ensuring your medical devices reach the market smoothly and compliantly.