Asia-Pacific Roundup: TGA seeks feedback on bringing assistive technologies into medtech framework

Australia’s Therapeutic Goods Administration (TGA) is considering regulating as medical devices certain assistive technologies for people with disabilities.

The agency defines assistive technologies as “household and personal aids, or furniture and utensils, for people with disabilities.” Currently, Australia excludes the products, which include technologies such as hand exercise devices, from regulation, treating them as consumer, rather than therapeutic, goods.

In its consultation on a proposal to bring these technologies into the therapeutic goods regulatory framework, TGA said the current exclusion was “established at a time when assistive technologies were frequently distributed to consumers through care models where they were often recommended by practitioners through facilities operated by a state or territory government.”

The way the products are supplied and used has changed over time, TGA said. The key changes include an increase in the scope of products that meet the exclusion criteria, as well as changes in their risk profile. TGA added that reimbursement for the cost of assistive technologies from private and public funding sources is on the rise and supply is moving to a direct-to-consumer model.

Feedback shows that “consumers using assistive technologies are exposed to risk, and the regulatory framework should safeguard against this in a consistent, proportionate manner,” TGA said. The agency has also heard that “publicly available information about these kinds of products is needed to facilitate reimbursement and post-market monitoring activities” and that exclusion may no longer be appropriate given the devices' new risk profile and “the reduction or removal of previous mechanisms for oversight.”

Removing the exclusion would mean products that meet the definition of a medical device would need to comply with the medtech regulatory requirements. Those requirements include meeting all relevant essential principles, including supplying the devices with adequate labeling and instructions for use and ensuring advertising complies with the requirements. Companies would also report adverse events.

TGA is considering removing the current blanket exclusion and introducing exemptions for some assistive technologies. Exempt devices are regulated by the TGA as medical devices but do not need to undergo a pre-market assessment or be included in the Australian Register of Therapeutic Goods (ARTG) before being imported, exported, or supplied.

The agency uses exemptions to reduce regulatory burdens when another regulatory framework manages risks associated with the device, supply may be restricted if an exemption is not introduced or evidence to support inclusion in ARTG is unavailable.

TGA is seeking feedback until 13 October. The agency expects to have results from the consultation by 29 November and feedback by 31 January 2025.

TGA Notice

TGA launches temporary arrangements for local and overseas GMP inspections

TGA is introducing “surveillance inspections” as a temporary new arrangement for good manufacturing practice (GMP) inspections of domestic and overseas manufacturers of medicines, active pharmaceutical ingredients, biologicals and blood products.

Surveillance inspections are “full-scope, reduced-duration re-inspections of manufacturers,” TGA said. As such, they will cover all aspects of a company’s pharmaceutical quality system and operations. The big difference is that surveillance inspections will take around half as long as a typical assessment. TGA said it could finish inspections that typically take four days in two days.

The agency framed the temporary arrangement as a response to the COVID-19 pandemic and the switch to remote inspections as a response to travel restrictions. While the approach provided continued GMP oversight, TGA said, “The initial delay in implementation and added complexity of remote inspections have contributed to a backlog of GMP inspections.”

By adopting surveillance inspections, TGA aims to maintain its risk-based re-inspection frequencies and ensure it meets the needs of the regulated industry. The goal is to maintain regulatory oversight of existing authorized manufacturers and monitoring of compliance while “reducing the number of overdue re-inspections to a level commensurate with manufacturer risk and reduce business disruption caused by delays to re-inspections.”

Surveillance inspections may be conducted on-site, remotely or as a hybrid inspection. TGA will only run one surveillance inspection at each eligible manufacturing site, and the resulting GMP certificates will “clearly state” that they are based on the shortened assessment. The agency expects to run the surveillance inspection program for up to two years.

TGA Notice

India changes duty on X-ray machine components to boost medtech industry

The Indian government has changed the custom duty on X-ray tubes and flat panel detectors used in medical X-ray machines. Government officials framed the change to boost the domestic medical device sector.

Last year, the Indian government established a national medical device policy to promote the sector's growth, make it more competitive globally, and reduce the country’s reliance on imported devices. The government used the publication of the budget for the 2024 to 2025 financial year as an opportunity to support the strategy.

The revised rates on X-ray tubes and flat panel detectors reflect industry feedback. In 2021, the Department of Pharmaceuticals proposed phased increases in the tariffs on medical X-ray machines and certain components. The goal was to increase domestic production and reduce reliance on imports by escalating duties on devices and components brought into the country.

However, industry representatives told the government that India is yet to develop domestic capacity for producing X-ray tubes and flat panel detectors. A government investigation found it will take at least two years for India to scale up domestic capacity to a level that meets local demand. That finding led officials to drop the phased increases in tariffs on the two components and adopt new duty rates.

The government disclosed the change alongside news of custom duty exemptions for three cancer drugs. Trastuzumab deruxtecan, a HER2-directed antibody-drug conjugate that AstraZeneca and Daiichi Sankyo sell as Enhertu, is one of the drugs. The government also removed duties on AstraZeneca’s Tagrisso in lung cancer and Imfinzi in lung and biliary tract cancer.

The actions are intended to make the drugs more affordable.

Press Release

TGA acts to mitigate IV fluids shortages at Baxter, B.Braun and Fresenius Kabi

TGA has approved multiple overseas-registered products to mitigate shortages of intravenous fluids sold by Baxter Healthcare, B.Braun and Fresenius Kabi in Australia.

Products from all three Australian fluid suppliers are in short supply. TGA attributed the shortages to factors including global supply limitations, unexpected increases in demand, and manufacturing issues. Multiple bag sizes of sodium chloride 0.9% and compound sodium lactate are among the worst affected products. The suppliers expect availability to remain constrained throughout 2024.

Hospitals rely on the products for fluid replacement, resuscitation, and administering other medications directly into the bloodstream, making them essential to routine and critical care. To help mitigate the shortage, TGA has approved six products that Baxter and Aborns Pharmaceuticals sell in France and the US.

TGA Notice

Other news:

The Philippine Food and Drug Administration (FDA) has scheduled a public consultation to discuss the guidelines on applying for a certificate of good manufacturing practice compliance. FDA is planning to repeal the existing rules and “implement an effective, timely, and modernized regulatory mechanism.” The public consultation meeting is set to take place on 9 August. FDA Notice

Asia-Pacific Roundup: TGA seeks feedback on bringing assistive technologies into medtech framework

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