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Medical Devices › Australia

Knobbe Martens

UK Proposes Approving Medical Devices Based on Approval in Other Countries

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Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Hogan Lovells

Consultation open: Review of the National Medicines Policy

Hogan Lovells on

The Department of Health (Department) has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee (Committee) is seeking feedback on a number of...more

Hogan Lovells

Failure to remove unlawful advertising attracts $12 million penalty

Hogan Lovells on

On 29 July 2021, the Federal Court of Australia (the “Court”) handed down its largest ever pecuniary penalty for serious, sustained and knowing contravention of the Therapeutic Goods Act 1989 (Cth) (“TG Act”). The decision...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Hogan Lovells

Reforms to software-based medical devices take effect this week

Hogan Lovells on

The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week,...more

Dechert LLP

Increased regulatory scrutiny of foreign direct investments in the healthcare sector

Dechert LLP on

Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus.  - Several countries have adapted their existing FDI rules, or...more

Knobbe Martens

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

Knobbe Martens on

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

Searcy Denney Scarola Barnhart & Shipley

Australia Concerned About Stryker Made LFIT Femoral Heads

Searcy Denney Scarola Barnhart & Shipley on

On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

K&L Gates LLP on

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

K&L Gates LLP

Global Food, Drug and Medical Device Newsletter

K&L Gates LLP on

In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

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