Efforts to bring greater harmonization to regulatory requirements and practices were emphasized during the recent Australia Regulatory Device Summit in Sydney[i]. For the first time, the Medical Technology Association of Australia (MTAA) and Regulatory Affairs Professionals Society (RAPS) teamed up to bring one of the largest MedTech-focused regulatory conferences down under.
With international regulatory convergence and collaboration as the overall theme, industry experts were joined by members of the International Medical Device Regulators Forum (IMDRF), to bring a quality, thought-provoking program. Among the agencies attending were the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), the European Union Commission, Singapore’s Health Sciences Authority (HSA), the Brazilian Health Regulatory Agency (ANVISA), and Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Regulators shared insights on trends and opportunities, and industry experts shared their experience on key challenges within the current regulatory frameworks.
Singapore (HSA)
Singapore positioned itself as an entry hub for Asia-Pacific (APAC) countries. Several jurisdictions now allow for expedited reviews with prior HSA approval (e.g. Australia, Thailand, Philippines, and Hong Kong). The agency’s update focused on its goal to expedite local reviews and leverage already reviewed datasets for new product applications. This included an overview of the agency’s new approach to regulating software as a medical device products (SaMDs) with pre-approved change control plans as part of their new Change Management Program (CMP for SaMD)[ii]. The agency also highlighted the flexibility of the Singapore framework, which includes consultation processes, multiple options for QMS certifications and file format (STED, CSDT), allowing manufacturers and dealers to utilize either international or local standards.
Japan (PMDA)
PMDA emphasized how Japan regulations leverage the works of the IMDRF, describing a hybrid model between US (e.g. classification system) and EU principles (e.g. use of standards and Notified Bodies) and the respective responsibilities of the Ministry of Health, Labour and Welfare (MHLW) and PMDA. Transparency and collaboration were also a focus. This was illustrated through the release of resources such as their public release of application review information[iii] and the opening of international offices in Thailand (July 2024) and the U.S. (November 2024). As the current chair of IMDRF, Japan will be hosting the next Management Committee meeting[iv] in Sapporo Hokkaido in September 2025.
Brazil (ANVISA)
Brazil’s ANVISA shared its two-year regulatory agenda and illustrated how the works of IMDRF have influenced local Resolutions over the years (e.g. RDC 751/2022). According to the agency, more than 50 percent of applications received now use Medical Device Single Audit Program (MDSAP) certifications. In 2024, ANVISA also released IN 290/2024[v] covering its “Abbreviated Analysis from overseas authorities”, which allows companies to undergo an abbreviated premarket pathway for products that have been already reviewed by equivalent agencies. At the time of the conference, 140 out of 314 applications received had been evaluated with 100 applications approved and only five rejected. The remaining 35 had yet to be reviewed at the time of writing.
US (FDA)
The US FDA discussed its International Harmonization Assessment Report (2024 CDRH report)[vi], highlighting the agency’s efforts toward more international convergence and knowledge-sharing amongst regulators (e.g. artificial intelligence), whilst also recognizing the complexities of bringing changes to the US framework. FDA discussed the progressive roll-out of e-STAR[vii] for pre-submissions and premarket applications (De-Novos by October 2025), the transition period until 2026, and the extent of recognition of ISO 13485 within its new Quality Management System Regulation (QMSR) Final Rule[viii].
New Zealand
The Medical Technology Association of New Zealand (MTANZ) shared industry’s concerns with the Therapeutic Product Act 2023 (which was passed by the previous government and since repealed, see the TPA Repeal Bill[ix]). It highlighted its potential to hinder access to medical technologies in the country, creating unnecessary regulatory burden for low-risk products, putting pressure on the regulator’s capacity to undertake premarket reviews, increasing costs for manufacturers, and insufficiently relying on overseas approvals. It warned that a change in local elections due in September 2025 could see the TPA back in action.
Europe
While industry has gained experience with the Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR) frameworks, and the capacity of Notified Bodies has improved over time, market entry in the EU remains challenging. Unavailable tools (EUDAMED – the European database on medical devices), convoluted guidance documents, a lack of harmonization in NB review practices, and unregulated timelines were cited. The EU commission discussed an action plan to improve system governance and enhance harmonization. Work is progressing on important issues such as the modular release of EUDAMED, the simplification of procedures (e.g. centralized applications for clinical trials in Europe), pathways for breakthrough devices (expect an update in October 2025), and MDSAP adoption.
Industry participants also shared their perspective on the relatively new EU AI Act[x] which will be fully applicable by July 2026, highlighting issues such as the lack of tools and guidelines for implementation in the context of Medtech, and the absence of any plans for postponements or transition timelines.
Australia (TGA)
In Australia, the TGA has been undertaking a significant program of reforms[xi] affecting the entire lifecycle of medical devices and IVDs. New types of overseas evidence are now accepted for TGA abridged reviews, including Singapore HSA approvals and US FDA 510ks for certain Class III devices. Discussions are also progressing with ANVISA and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to deploy similar reliance models. Industry representatives, particularly companies headquartered in the EU and the U.S., highlighted the importance of this shift, opening new opportunities for market access in Australia. This was echoed by the agency, which reported a shift in EU reliance from 90 percent in 2020 to 78 percent in 2025.
Unique Device Identification (UDI)
With the recent launch of Unique Device Identification (UDI)[xii] in Australia, the regulators provided an update on the status of implementation of UDI in their respective countries. Singapore shared the mechanisms in place within its Singapore Medical Device Register (SMDR) database[xiii], Brazil is continuing to work on the implementation of RDC 591/2021[xiv], collaborating with the TGA for the development of the Unique Device Identification System database (Siud)[xv]. And in Japan, the PMDA is still supporting MLHW which is responsible for rulings on UDI and the creation of a public database.
Insight for Manufacturers
Manufacturers around the world must navigate complex and diverse regulatory frameworks for global market entry. A good regulatory strategy should include an actionable plan to support the company’s commercial vision, where possible, leveraging international approvals and systems to fast-track market access and deliver efficiencies.
About the Author
Jean Boudaud is a quality and regulatory expert with nearly two decades of industry experience, primarily gathered in the Medtech and consulting industry. In his current role, he is responsible for the delivery of Medtech consulting services from the PharmaLex APAC regional hub. Together with his team, he guides companies of all sizes through the complexities of global regulatory frameworks and provides hands-on regulatory support through the entire medical device lifecycle. He holds a master’s degree in engineering (MEng.) and is bilingual French and English.
[i] Australia Regulatory Device Summit, MTAA. https://www.mtaa.org.au/events/australia-regulatory-device-summit-2025
[ii] Consultation on Guidance on Change Management Program (CMP) for SaMD, HSA. https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd
[iii] Review Reports: Medical Devices, PMDA. https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html
[iv] IMDRF 28th Session, September 15-19 2025, Sapporo Japan, IMDRF. https://www.imdrf.org/news-events/imdrf-28th-session-september-15-19-2025-sapporo-japan
[v] Normative Instruction – In N° 290, of April 4, 2024, ANVISA. https://www.in.gov.br/web/dou/-/instrucao-normativa-in-n-290-de-4-de-abril-de-2024-552512770
[vi] CDRH International Harmonization Annual Assessment, Fiscal Year 2024, FDA. https://www.fda.gov/media/185222/download
[vii] eSTAR Program, FDA. https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program
[viii] Medical Devices; Quality System Regulation Amendments, Federal Register. https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
[ix] Therapeutic Products Act Repeal Bill, New Zealand legislation. https://www.legislation.govt.nz/bill/government/2024/0067/latest/whole.html
[x] EU Artificial Intelligence Act. https://artificialintelligenceact.eu/the-act/
[xi] Medical devices reforms, TGA. https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-devices-reforms
[xii] Launch of the Australian UDI regulatory framework and Australian UDI Database, TGA. https://www.tga.gov.au/how-we-regulate/tga-learn/online-education-events/presentations/launch-australian-udi-regulatory-framework-and-australian-udi-database
[xiii] Singapore Medical Device Register, HSA. https://share.hsa.gov.sg/medics/PublicListing/Smdr
[xiv] Resolution – RDC No. 591. https://in.gov.br/en/web/dou/-/resolucao-rdc-n-591-de-21-de-dezembro-de-2021-370622845
[xv] Anvisa presents UDI system and regulatory updates on medical devices, ANVISA. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-apresenta-sistema-udi-e-atualizacoes-regulatorias-sobre-dispositivos-medicos
