• 2026-09-21 03:51:16

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

• 2026-09-21 02:42:09

The Department of Health (DH) of Hong Kong issued a letter regarding the updated regulatory requirements for the use of injectable and infusible product in licensed Private Healthcare Facilities (PHFs) which cover pharmaceutical products, human organ/human tissue product, and medical device. For medical devices, the DH has announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the MDACS, effective 1 March 2027. This new requirement specifically includes injectable dermal fillers and injectable mucous membrane fillers.

• 2026-07-28 03:07:42

Japan is advancing its surgical robotics sector, driven by an aging population and healthcare workforce shortages. Robotic-assisted surgery is expanding across urology, general surgery, and orthopedics, supported by growing public insurance coverage and rising institutional investment. Backed by a fast-growing market, Japan presents strategic opportunities for global medical device companies targeting the Asia-Pacific region.

• 2026-07-27 03:54:16

HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.

• 2026-07-27 03:42:33

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

• 2026-06-26 06:43:53

Singapore's Healthier SG initiative is accelerating the national transition toward preventive and personalized healthcare. Driven by an aging population and rising chronic disease burden, the program is expected to increase demand for remote patient monitoring, diagnostic technologies, and digital health solutions. These developments present significant opportunities for medical device companies seeking to participate in Singapore's growing preventive care market.

• 2026-05-27 10:33:27

On 20 April 2026, Singapore's Health Sciences Authority (HSA) and Japan's Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation (MOC) in Tokyo to enhance bilateral regulatory collaboration. The press release (issued on 21 April 2026) notes that the MOC aims to promote reliance for health products, establish mutual reliance for Good Manufacturing Practice (GMP) inspections, and support information exchange on emerging technologies.

• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

• 2026-03-31 09:43:08

Qualtech's expansion into New Zealand, marked by the opening of our 15th office, highlights a market that combines accessible regulatory pathways with growing healthcare demand. With no pre-market approval required and a notification-based system, New Zealand offers an efficient entry route for medical devices. At the same time, increasing healthcare investment, aging population, and infrastructure development are driving demand for advanced medical technologies, positioning the market as a strategic opportunity within APAC.

• 2026-03-02 02:28:47

Singapore's Smart Health initiative leverages technology to transform healthcare, addressing an aging population and driving demand for innovative medical devices. As a regional hub with high healthcare spending and import dependency, Singapore offers significant opportunities for med-tech companies focusing on digital health, AI, and assistive technologies. This article will highlight the insights for medical device businesses to leverage Singapore's Smart Health vision.