News & Analysis as of

Medical Devices Amended Regulation

Smart & Biggar

Permanent regulatory framework for COVID-19 medical devices now in force

Smart & Biggar on

On February 22, 2023, amendments to the Medical Devices Regulations (Regulations) came into force that create a permanent regulatory framework for COVID-19 medical devices...more

Latham & Watkins LLP

EU MDR Transitional Provisions Officially Extended

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The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more

Smart & Biggar

New guidance documents and regulatory amendments regarding therapeutic product shortages

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As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more

Smart & Biggar

Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for...

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On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more

Smart & Biggar

Regulatory amendments provide permanent measures to address therapeutic product shortages

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On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Baker Donelson

Medicare Spreads Sunshine Act Coverage to New Categories of Payments, Recipients

Baker Donelson on

On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Smart & Biggar

Final regulations addressing the public release of clinical information now in force

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On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)...more

Mintz - Health Care Viewpoints

How to Safely and Productively Promote an FDA-Regulated Medical Product

As any medical product business knows, compliance with the AdvaMed Code of Ethics (the “Code”) is essential. While the Code is voluntary, many states require medical product manufacturers and companies to adopt compliance...more

Smart & Biggar

Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

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