• 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 03:03:43

The Medical Device Authority (MDA) of Malaysia has announced a commencement of the second phase of The Malaysia–China Joint Evaluation Pilot Programme upon successfulness of Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I) in 2025. Pilot phase 2 will run from 1 July 2026 to 30 September. The programme enables the MDA and China's National Medical Products Administration (NMPA) to conduct a collaborative joint evaluation of eligible medical device registration applications under the GHWP Common Evaluation Reliance Practice (CERP).

• 2025-10-27 06:53:05

The Asia Pacific aesthetic devices market will grow from USD 5.0 billion in 2024 to USD 11.5 billion by 2032, driven by minimally invasive treatments, innovation, and medical tourism. Emerging trends in preventive care, home-use devices, and male aesthetics create diverse opportunities across China, Japan, South Korea, Thailand, and Vietnam. Manufacturers that adapt to local demand and regulations will capture this expanding market.

• 2023-07-21 03:49:06

The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.

• 2023-02-23 01:45:57

A pilot run for new requirements on the procurement of medical devices by the Department of Health (DH) will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by Department of Health should preferably be listed under MDACS.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

• 2022-12-27 07:25:52

On October 17th, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Japanese Standard for Sterilization Validation.

• 2022-11-29 02:56:30

Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.

• 2022-09-27 08:23:11

A pilot run for the new requirement on the procurement of medical devices by the Department of Health will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by the Department of Health should preferably be listed under MDACS.

• 2022-08-30 03:36:34

The Malaysian Medical Device Authority (MDA) issued the Fifth Edition Guidance for Labeling on Registered Medical Devices. The document's goal is to provide manufacturers and authorized representatives with a guidance on the content of medical device labelling.