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

TGA Emphasizes Medical Device Distribution Record-Keeping

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

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Hong Kong Increases Prioritization of Registered Medical Devices

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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).

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Key Takeaways from VietNam’s CSDT Conference

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

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Singapore’s HSA Increases Medical Device Registration Fees

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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.

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Software as a Medical Device in Thailand

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

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TGA Updates Rules for Medical Device Manufacturers

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

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Hong Kong Prepares Office for Mandatory Medical Device Regulations

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

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Thai FDA Regulatory Documentation Exemptions

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March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation.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.

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Australia Issues New Guidance on AIMD and MLMD

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

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India Extends Deadline for Class C and D Import Licenses

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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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