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AUSTRALIA: Essential Principles - Consent for Noncompliance – January, 2022

AUSTRALIA: Essential Principles - Consent for Noncompliance – January, 2022

  • 2022-01-26 04:00:20

Despite it being a criminal offense to import, supply or export medical devices that do not meet the EPSP, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. TGA Australia grants exemption in certain situations. Here we gather some FAQs related to the application of the consent for non-compliance of the medical devices and summarize this article in order to help you understand what you need to know for the condition and application.

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QT WEBINAR: New CER Requirements in China

QT WEBINAR: New CER Requirements in China

  • 2021-12-27 06:33:04

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "New CER Requirements in China". Our event is scheduled to be held on January 21st (Friday), 2022.

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MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

  • 2021-12-27 06:04:00

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

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AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

  • 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

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AUSTRALIA: Custom-Made Medical Devices – November, 2021

AUSTRALIA: Custom-Made Medical Devices – November, 2021

  • 2021-12-27 01:30:53

TGA has introduced a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG) if they are being supplied in volumes of more than five per financial year.

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