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TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

  • 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.

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China: Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council

China: Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council

  • 2021-04-26 02:33:36

On December 21, 2020, State Council in China announced the adoption of New Regulations on the Supervision and Administration of Medical Devices (Medical Devices Order. 739 of the State Council). Respectively on March 18, 2021, State Drug Administration officially issued the revised Regulations on the Supervision and Administration of Medical Devices, corresponding with a set of Draft Measures.

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QT ANALYSIS: New GDPMD Regulation in Taiwan

QT ANALYSIS: New GDPMD Regulation in Taiwan

  • 2020-12-24 11:05:44

TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.

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TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR"  – November, 2020

TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR" – November, 2020

  • 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

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