Asia-Pacific Roundup: TGA updates regulations on software-based medical devices, other medtech products

Australia’s Therapeutic Goods Administration (TGA) has changed the regulation of multiple types of medical devices, including software-based medical devices; prescription spectacle lenses; products containing microbial, recombinant or animal substances; and application audits.

The changes to software-based medical devices and prescription spectacle lenses took effect last week. In February 2021, TGA introduced transitional arrangements for software-based medical devices moving to a higher risk classification. As of 15 June, companies that have sent a TGA conformity assessment certificate application can use an alternate transition pathway. The pathway is open to companies that notified TGA before 25 May 2022.

The pathway allows sponsors and manufacturers to meet the transitional arrangements by filing an application for inclusion in the Australian Register of Therapeutic Goods (ARTG) and applying for TGA conformity assessment by 1 November. Companies that meet the deadline can continue to supply their software-based medical devices until TGA rules on their applications.

The revised rules on prescription spectacle lenses also took effect on 15 June. TGA has exempted the products from the requirement for inclusion in the ARTG before import, export or supply in Australia. Prescription lenses for treatment, such as products with peripheral optics control for slowing myopia in children, still need to be added to the ARTG. TGA said it made the changes because the regulations were “interpreted and applied inconsistently at times.”

Changes to the regulations of medical devices containing microbial, recombinant or animal substances will take effect on 1 July. TGA is changing the rules on the classification of these devices regarding the risk of transmissible spongiform encephalopathies (TSEs).

Rule 5.5, which categorizes medical devices as high risk, will no longer apply to some products, such as those that only contain tissues, cells, or substances of microbial or recombinant origin. Sponsors of affected ARTG entries need to seek reclassification before 1 July 2026. Affected sponsors can keep supplying under their existing ARTG entries unless the reclassification application is unsuccessful.

The other changes taking effect on 1 July limit mandatory application audits to high-risk medical devices and in vitro diagnostic (IVD) devices. Mandatory application audits will apply to class III medical devices supported by EU Medical Device Directive certification, the US Medical Device Single Audit Program (MDSAP), and 510(k) clearance, as well as to IVDs, including class 3 and 4 devices.

TGA Notice

Australia set to ban compounding of GLP-1 drugs in October

Australia has changed its Therapeutic Goods Regulations to prohibit pharmacists from compounding GLP-1 receptor agonists, regardless of dosage form, effective 1 October.

Compounding pharmacists stepped in as demand for GLP-1 drugs such as Novo Nordisk’s Ozempic (semaglutide) and Eli Lilly’s Mounjaro (tirzepatide) outstripped supply. Officials in Australia, the US, and other countries, as well as manufacturers of the branded products, have raised concerns about the safety and quality of compounded GLP-1 medicines.

TGA acknowledged that medicines such as Ozempic, Mounjaro, and Lilly’s Trulicity (dulaglutide), all of which are subject to supply constraints in Australia, are important for health and well-being, and patients need a reliable supply. However, the agency advised that patients who currently rely on compounding pharmacies will need to switch treatments.

“We encourage patients who have been accessing these compounded products to speak to their [general practitioner] about alternative treatment and general healthcare plans,” TGA said. “While we recognise shortages cause significant anxiety for patients, it is important that the alternative treatments accessed during shortages are safe and of good quality.”

The ban on compounded GLP-1 drugs will take effect before the regular supply of all branded products resumes. Lilly has told TGA that the normal supply of Mounjaro could resume at the start of September, but it expects the availability of Trulicity to be limited until the end of 2024. Novo Nordisk has told TGA that the supply of Ozempic will be limited throughout 2024.

TGA is hosting a webinar on 14 August to explain the changes and discuss the impact on consumers, pharmacists and doctors.

TGA Notice

China’s NMPA advances work on vaccine quality management system

China’s National Medical Products Administration (NMPA) has discussed the construction and operation of its vaccine regulatory quality management system (QMS).

Scandals involving the sale of improperly stored products, the use of expired active ingredients and the forging of data have raised concerns about the oversight of vaccine supply in China over the past eight years. NMPA has worked to strengthen the regulation of vaccines over that period, leading to two recent meetings intended to enhance the construction of the QMS and facilitate coordination of the system.

“The meetings briefed on the construction and operation of the NMPA's QMS and introduced the NMPA's experience in its internal control system, vaccine registration and marketing authorization quality management, internal audit and service object satisfaction survey,” NMPA said.

NMPA used the meetings to provide updates on its work to ensure the consistency of vaccine lot release network laboratories, the construction of the QMS for drug inspection and the operation of the QMS for technical review of medical products. Provincial medical products administrations shared information on the operation of the QMS in their jurisdictions.

NMPA Notice

TGA starts proceedings over alleged supply of unapproved rapid antigen test kits

TGA has started legal proceedings against Key Promotional Products (KPP) over the alleged importation and supply of unapproved rapid antigen test kits.

KPP is accused of importing tests designed to detect COVID-19 that were not in the Australian Register of Therapeutic Goods or covered by other approvals or exemptions. The company allegedly supplied at least 240,000 of the tests to resellers in Australia and made false or misleading representations that the products were “TGA Approved” or had “TGA Approval.”

TGA has begun proceedings against KPP and a person it alleges was responsible for the company's day-to-day running and aided and abetted the contraventions. The agency has started proceedings in the Federal Court of Australia.

TGA Notice

Other news:

India aims to upgrade all drug and medical device manufacturing plants to “world-class standards” over the next three years. The recently appointed Union Minister for Chemicals & Fertilizers, Shri Jagat Prakash Nadda, made the commitment and said quality should receive “renewed focus” at a meeting of the Department of Pharmaceuticals. Press Release

The Pharmacy and Poisons Board of Hong Kong has endorsed the regulation of medical gases as pharmaceutical products from 14 June 2026. The board agreed to the change in September, and the Department of Health held a public consultation in November. With most respondents supporting the change, the board has enacted the policy and given the industry two years to transition. Press Release

Asia-Pacific Roundup: TGA updates regulations on software-based medical devices, other medtech products

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