Tag Archive for: regulatory updates

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March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation.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

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On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.

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Thai FDA QMS Updates to Affect GDP, GMP, and GCP

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Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.

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Thailand FDA to Decrease Registration Application Processing Times

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The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.

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CHINA: REGULATORY AND COMMERCIAL UPDATES

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The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

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