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AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

  • 2021-06-25 10:40:40

Medical devices cannot generally be imported, supplied in, or exported from Australia unless they are included in the ARTG (Australian Register of Therapeutic Goods. Only an Australian sponsor can apply to include an IVD (In Vitro Diagnostics) in the ARTG. TGA has now issued requirements to be fulfilled in order to include an IVD in the ARTG.

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QT ACTIVITY: Post-Brexit medical device regulatory landscape

QT ACTIVITY: Post-Brexit medical device regulatory landscape

  • 2021-06-04 09:34:53

In this webinar, you will learn more about Brexit and how Geopolitics affects medical device regulations. Our expert will introduce you to UKCA. Moreover, Ms. Fatehi will discuss the transitioning out period and will outline how the future for the U.K. market will look like.

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China: Notice on Registration of Medical Device Technical Dossier–May, 2021

China: Notice on Registration of Medical Device Technical Dossier–May, 2021

  • 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

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MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

  • 2021-05-22 05:17:57

In April 2021, Medical Device Authority (MDA) published new guidelines for the implementation of a medical device regulator system which is listed the requirements for application for medical device advertisement approval. The guidelines are to helps the establishment to comply with the regulations Act 737. These guidelines shall be read together with Guidance Documents of Code of Advertisement (COA).

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 AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

  • 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

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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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