A leading European medical device company specialising in AI-powered solutions launched operations in Australia in 2022. Their advanced products, built using convolutional neural networks to analyze MRI and other medical images, enhance efficiency and deliver reliable results, addressing the needs of radiologists in high-pressure environments. With Australia’s eHealth market experiencing rapid growth, the company identified the region as a strategic hub for expanding their operations and delivering cutting-edge technology to local healthcare providers.
Challenge
To successfully enter the Australian market, the company faced several challenges, including navigating complex regulatory requirements, ensuring compliance with Therapeutic Goods Administration (TGA) standards, and establishing a local presence. They required operational support and quick company setup to engage healthcare providers and begin selling their products without delay.
Solution Provided by Abdera
The company partnered with Abdera Pty Ltd for a tailored solution that addressed their unique needs:
1. Company Establishment and Local Representation
Abdera facilitated the swift establishment of the company’s Australian entity, ensuring all legal and administrative requirements were met. Abdera also acted as the company’s local representative, serving as their TGA sponsor—a critical role for entering the highly regulated medical device market.
2. Regulatory Compliance
Abdera guided the company through Australian statutory regulations, ensuring full compliance with TGA guidelines and other obligations necessary for selling medical devices in the region.
3. Corporate and Operational Services
To streamline market entry, Abdera provided comprehensive corporate and operational support, including HR and payroll setup, tax registration and compliance, and assistance with employee onboarding. This ensured the company was operational and ready to engage with Australian healthcare providers seamlessly.
4. Strategic Advisory
As a trusted business advisor, Abdera offered ongoing strategic support, helping the company adapt to the Australian market and establish relationships with key stakeholders in the healthcare sector.
Outcome
With Abdera’s support, the company successfully launched its operations in Australia. They quickly engaged with healthcare providers, delivering their innovative AI-powered solutions to address the needs of the radiology and eHealth markets.
By providing a comprehensive, end-to-end solution, Abdera ensured the company’s compliance with all regulatory requirements, allowing them to focus on business growth and innovation in a competitive market.
