TGA Emphasizes Medical Device Distribution Record-Keeping
On May 23rd, 2024, the Therapeutic Goods Administration (TGA) updated its distribution records page for medical devices.
A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
On May 23rd, 2024, the Therapeutic Goods Administration (TGA) updated its distribution records page for 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).
On June 28, 2024, The Vietnam Ministry of Health hosted a training session on how to prepare an ASEAN MDD Common Standard Technical Document.
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.
On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand.
On June 14th, 2024, the TGA made some amendments (2024 Measures No.2) to Australia’s 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).
March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation.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.
On May 9th, 2024, Australia’s Therapeutic Goods Administration (TGA) updated its guidance for AI Medical Devices and Machine Learning Medical Devices.
On May 16th, 2024 India’s CDSCO extended allowances for the importation of Class C and D Medical Devices currently under review.
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