MTAA launches Australian-first medtech regulatory community

MedTech & Diagnostics News: The Medical Technology Association of Australia (MTAA) has today launched the nation’s first medtech regulatory community, RegConnect, at a full-day event hosted at the International Convention & Exhibition Centre Sydney (ICCS).

Since joining the MTAA, Jasjit Baveja, Director of Regulatory and Industry Policy, has recognised the pressing need for clarity and consistency in regulatory processes.

Drawing from her extensive industry experience, Baveja recognised the fragmented ways companies approach regulatory requirements. To address this, The MTAA approached the Therapeutic Goods Administration (TGA) with a proposal for targeted workshops designed to bridge the gap between industry and the regulatory body.

“That would save a lot of back and forth, and streamline processes on both sides to allow timely patient access to life-saving medical devices,” Baveja told Health Industry Hub.

These workshops, initiated in early 2022, have proven successful. They began with a one-day pre-market session, culminating in a five-day workshop series in July with 150 participants from MTAA member companies and 28 TGA staff members.

Recognising the need for support beyond MTAA members, Baveja spearheaded the creation of the RegConnect community, aimed at fostering collaboration among regulatory professionals, medtech startups, students, and non-members.

“RegConnect will provide a platform for regulatory professionals across Australia to unite,” she explained.

Baveja emphasised the importance of strategic partnerships, including an upcoming Memorandum of Understanding (MOU) with Regulatory Affairs Professionals Society (RAPS) and ARCS Australia focusing on the local pharmaceutical and medical device sectors while incorporating emerging international trends.

“There’s significant interest from overseas companies eager to navigate the Australian regulatory environment,” she remarked. “And similarly, there is growing interest from local medtechs who want to expand their footprint into the U.S. and European markets.”

As the industry navigates regulatory consultations in UDI (unique device identification) and AI, Baveja stressed the importance of striking the right balance between oversight and innovation.

“We’re already operating in a highly regulated space. Introducing additional layers of scrutiny in AI, for example, risks stifling innovation,” she cautioned, underscoring the vital role the industry must play in shaping the future regulatory framework.

The launch of the RegConnect community represents a pivotal step towards fostering collaboration, consistency and transparency within Australia’s medtech regulatory landscape.

As Baveja aptly summarised, “This is a first-of-its-kind initiative that brings us together to learn and support one another, and ensure our industry’s voice is not only heard but shapes the future of the regulatory environment.”

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