Asia-Pacific Roundup: HSA partners with trade group to support Singapore’s medtech industry

The Health Sciences Authority (HSA) has partnered with a trade group to provide early regulatory consultations and other support to Singapore’s medtech industry.

HSA is working with the Singapore Manufacturing Federation Medical Technology Industry Group (SMF MTIG) on the project. The alliance combines the technical regulatory expertise of the Health Products Regulation Group (HPRG) Innovation Office at HSA with the services provided by an SMF team that helps small- and medium-sized enterprises (SMEs).

“This dual-pronged approach transforms the regulatory journey from reactive compliance to proactive guidance, offering early consultations during product development or registration,” HSA said. “It also promotes awareness to HSA’s agile frameworks and new initiatives such as the mutual reliance pilot between [the] Medical Device Authority of Malaysia and HSA.”

HSA has established reliance programs with Australia, Hong Kong, Philippines, Thailand, and Sri Lanka. As of September 2025, more than 500 medical device applications have been processed through Thailand and Australia’s reliance on HSA’s approvals, the Singapore regulator said.

The agency added that the new program is intended to help medical device companies “to capitalize on Singapore's growing international regulatory influence while receiving the guidance needed to navigate these accelerated approval processes effectively.” HSA and SMF MTIG want to provide those benefits by aligning regulatory expertise and industry support infrastructure.

HSA CEO Raymond Chua said the close partnership between the agency and industry group will enable the co-creation of “forward-looking regulatory frameworks that accelerate breakthrough technologies to market whilst upholding our unwavering commitment to patient safety.” The SME team at SMF will offer guidance on available programs and facilitate connections between HSA and other organizations.

The creation of the HPRG Innovation Office at HSA has brought together all the agency’s agile regulatory frameworks and sandbox initiatives. HSA cited its work on change management for software as a medical device, the regulatory e-system and a cybersecurity labeling scheme as examples of agile frameworks that it has set up for the medtech industry.

Press Release

Japan’s PMDA outlines position on animal testing alternatives for quasi-drugs

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) signaled its intention to support new alternatives to animal testing for non-clinical studies required for the application of quasi-drugs.

The term quasi-drugs covers products such as medicated cosmetics and hair growth products that have milder effects on the human body than pharmaceuticals but are too strong to fall into one of the other regulatory categories. PMDA wants to change how companies gather non-clinical evidence to support regulatory filings for quasi-drugs.

“There are some test methods for which non-animal evaluations have not yet been established, and it is urgent to establish further alternatives to animal testing and construct new evaluation systems that combine multiple evaluation methods from industries related to quasi-drug,” PMDA said.

To further that goal, PMDA intends to assess alternatives to animal testing and publish guidance on individual techniques in cooperation with stakeholders. The agency plans to collect data on studies run using alternatives to animal testing in Japan and overseas. PMDA named microphysiological systems as a method that it could consider as it assesses alternatives to animal testing.

The activities are intended to identify points to consider for the development and use of alternatives and to inform the creation of a new scientific advice framework for using non-animal testing methods to file for regulatory approval.

As well as reducing the use of animals in product development, switching to alternative tests could solve problems such as species-level differences in reactivity. PMDA framed its pursuit of those benefits in the context of a global push to reduce animal testing. The efforts have seen PMDA establish 13 guidance documents on alternatives, but Japan still relies on animals for some test methods.

PMDA Paper

TGA warns against importing unregistered GLP-1 medicines into Australia

The Therapeutic Goods Administration (TGA) has published a safety advisory about the importation of unregistered GLP-1 products into Australia.

TGA said the products are being promoted online for weight loss. Often marketed as GLP-1 peptide oral drops or liquids, the agency said the products “may be falsely labeled as approved by international regulators or advertised with misleading quality marks or claims with the aim of deliberately deceiving consumers.” TGA has received reports of ads using fake health professional and celebrity endorsements.

The agency shared the safety advisory on the same day that it publicized actions it has taken against Midnight Health. TGA issued 10 infringement notices, totaling AU$198,000 ($131,000), to the company for alleged unlawful advertising of prescription-only weight-loss medicines.

Midnight Health ran telehealth platforms such as Youly, Stagger, and hub.health. TGA said the company used the platforms to advertise prescription-only weight-loss medicines to the public between June 2024 and January 2025. The websites allegedly promoted the use and supply of tirzepatide and semaglutide, the active pharmaceutical ingredients in Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy.

The company has paid the infringement notices. TGA accepted a court enforceable undertaking from Midnight Health, which acknowledged that the websites likely contravened relevant advertising rules. The one-year undertaking requires the company to engage a compliance and legal consultant and take other actions. Midnight Health could face financial penalties if it breaches the undertaking.

TGA Notice, More

HSA launches eCTD portal, marking start of 6-month test submission phase

Singapore’s HSA has launched an electronic common technical document (eCTD) portal and begun accepting test submissions ahead of the use of the platform.

HSA launched the portal on 30 September. The agency is encouraging companies to file test submissions to familiarize themselves with the new system. Companies should use dummy application numbers and not make actual submissions. None of the test submissions will be processed for regulatory review. HSA will remove the submissions from the system when the six-month test period ends on 27 March.

Companies will need to obtain eCTD identification to send submissions. HSA has prepared resources such as a training presentation, question and answer document, and a portal user manual to help people navigate the new system.

The agency will start accepting actual submissions in the eCTD format on 1 April.

Press Release

India’s CDSCO clarifies regulatory pathway for lyophilized dry powder combipacks

India’s Central Drugs Standard Control Organization (CDSCO) has clarified the pathway for approval of combipack products that contain lyophilized dry powder and diluents for reconstitution.

The notice covers products that include dry powder for injection or infusion and diluents such as sterile water for reconstitution. CDSCO has received requests for clarification of the regulatory pathway for such products, leading the agency to publish a notice last week.

Officials said products that have been approved by CDSCO for more than four years and are being used in line with their prescribing information are not considered new drugs. State authorities may license those products. CDSCO has classified combipacks that contain different drugs or diluents as new drugs. Those products require CDSCO permission before state authorities can grant licenses.

CDSCO Notice

Other News:

Australia has updated therapeutic goods legislation that covers procedures for examination, testing, and analysis. TGA identified problems with the legislation last year, leading to a consultation and reforms intended to improve the clarity and functionality of the rules. The amended legislation took effect on 1 October. TGA Notice

Asia-Pacific Roundup: HSA partners with trade group to support Singapore’s medtech industry

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