A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Singapore’s HSA to Increase Fees in July 2022

Singapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.

TGA Emphasizes Medical Device Distribution Record-Keeping

On May 23rd, 2024, the Therapeutic Goods Administration (TGA) updated its distribution records page for medical devices.

Hong Kong Increases Prioritization of Registered Medical Devices

On July 4th, 2024, the Hong Kong Department of Health (DH) released an update on the upcoming enhancements to their procurement strategy concerning the registration of Applicable Medical Devices (AMDs).

Key Takeaways from VietNam’s CSDT Conference

On June 28, 2024, The Vietnam Ministry of Health hosted a training session on how to prepare an ASEAN MDD Common Standard Technical Document.

Singapore’s HSA Increases Medical Device Registration Fees

Starting July 1st, 2024, Singapore’s Health Science Authority (HSA) has announced that they will increase their review fees in Singapore for all registration routes.

Software as a Medical Device in Thailand

On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand.

TGA Updates Rules for Medical Device Manufacturers

On June 14th, 2024, the TGA made some amendments (2024 Measures No.2) to Australia’s medical device regulations.

Hong Kong Prepares Office for Mandatory Medical Device Regulations

On June 5th, Hong Kong’s Department of Health (DH) announced plans for the establishment of the Centre for Medical Products Regulation (CMPR).

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.

Australia Issues New Guidance on AIMD and MLMD

On May 9th, 2024, Australia’s Therapeutic Goods Administration (TGA) updated its guidance for AI Medical Devices and Machine Learning Medical Devices.