Case Study: Product Portfolio Expansion in Australia
About Client Company
A global China-based company at the forefront of its endeavour and is one of the leading in-vitro medical devices manufacturers specialization in alcohol testing in blood. Company has commitment for excellence and innovation and has established itself as a trusted name in the medical device industry not only in China but also in other regions. Company has speciality for providing reliable solutions to healthcare professionals and end users. The company wanted to register its manufacturing unit in Australia to expand its business. The company wanted to get more assistance and expertise on regulations and gap analysis, so the company contacted the well-known Healthcare Consulting firm DiseaseLandscape Insights (DLI).
Challenges-
The client had already registered the IVD kits in several global markets and wanted to expand its manufacturing unit for IVD in Australia. Since the IVDs had to be registered according to Therapeutic Good’s Administration’s (TGA) regulations, the company faced challenges that required a holistic strategy in device classification, review of technical files, gap analysis, and further regulatory submissions.
Solutions
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Regulatory Expertise and Guidance:
DLI supported the company with a delegated team of experienced regulatory experts who were familiar with the TGA's regulations. Experts of DLI assisted the company in understanding the specific requirements for IVD kit registration in Australia and ensured that the client navigates the regulatory process smoothly and avoids potential delays and pitfalls.
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Gap Analysis and Technical File Review:
DLI conducted a comprehensive gap analysis of the company's current documentation and technical files related to the IVD kits. Experts of DLI identified gaps that needed to be addressed before the TGA submission.
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Device Classification Assistance:
DLI also assisted the client in correctly classifying the IVD kits according to the TGA's regulations. As device classification played a crucial role in determining the regulatory requirements and the level of scrutiny that was needed during the review process.
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Regulatory Submissions Support:
DLI helped the company in preparing and submitting the necessary regulatory documents to the TGA and collaborated with the company's higher management who had previously handled the regulations in other regions. This included compiling technical data, clinical evidence, labeling requirements, and other relevant information about the company.
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Post-Market Compliance Assistance:
DLI also supported the client after IVD kits were successfully registered, DLI continued to provide support in terms of post-market compliance as per clients' demand. DLI services also involved ongoing regulatory surveillance, vigilance reporting, and adherence to any post-market requirements imposed by the TGA.
Outcomes:
- After clearly understanding the regulatory landscape, the company efficiently planned and allocated resources for the registration process, reducing time-to-market and accelerating expansion into the Australian market.
- Addressing gaps in the technical files early ensured that the company's submission to the TGA was completed and filed accurately. Addressing the gaps reduced the risk of rejection or resubmissions, which helped the company to move forward with the registration process more efficiently.
- Proper device classification ensured that the company complied with the right regulatory pathway, which saved time and resources. It also helped the company to properly understand the level of evidence that was required for demonstrating the safety and performance of the IVD kits, streamlining the registration process.
- A well-prepared regulatory submission with DLI’s service helped the company to increase the likelihood of approval from the TGA. Faster approvals mean quicker market access; thus, it helped the company to capture all the opportunities and thereby gained a competitive edge in the Australian market.
- Post-market compliance offered by DLI helped to maintain the client's reputation and credibility in the Australian market. It also helped in minimizing the risk of regulatory non-compliance issues that could have otherwise hindered further expansions and growth.
Conclusions:
Overall, DLI engaged with a medical device company to address these challenges of IVD kit registration in Australia despite having strong regulations, which has now significantly benefited the China-based manufacturer in terms of streamlining the regulatory process, reducing time-to-market, and ensuring post-market compliance. The company also focused on expanding its business and capturing all opportunities in new Australian market. Additionally, a successful registration in Australia also enhanced the client's reputation, which attracted potential partners and investors for the company, and opened doors for further expansion into other countries with similar regulatory requirements.
