Newsletter

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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Evaluation Principles of Medical Devices for Home Medical Care in Japan

Evaluation Principles of Medical Devices for Home Medical Care in Japan

  • 2021-10-27 07:52:46

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

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QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

  • 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

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