• 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.

• 2021-05-22 04:28:32

On April 20, 2021, Malaysia Medical Device Authority (MDA) published a revision list of Medical Device-Drug-Cosmetic Interphase (MDDCI) products. MDA has classified they regulated medical device and combination products that primary intended use of the device and the primary mode of action is to be used as a medical device.

• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.