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Summary Reports and Issue-related Analysis Reports

Summary Reports and Issue-related Analysis Reports

A Periodic Summary Reports is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. Summary Reports are required by Health Canada for all medical devices. The reporting timeline for medical device...

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Medical Device Incident reporting

Medical Device Incident reporting

Health Canada requires the manufacturer and importer to submit both a preliminary and a final mandatory report constituting the details of any incident relating to the failure of a medical device or any inadequacy in its labelling or in its directions for use...

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Foreign Risk Notification (FRN)

Foreign Risk Notification (FRN)

Health Canada intends to improve the collection and assessment of new information relevant to the safety of a medical device in certain foreign jurisdictions to help determine an appropriate response in Canada to any risks reported. Per the Foreign Risk Notification...

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Health Canada Monograph Revisions Coming Soon!

Health Canada Monograph Revisions Coming Soon!

The Natural Non-Prescription Health Products Directorate (NNHPD) has an important update - they will begin revising all NHP monographs. The primary objective of the monograph revision initiative is to modernize the NHP monographs, ensuring they meet the new NHP...

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California Expands Cosmetic Safety Regulations with AB 496

California Expands Cosmetic Safety Regulations with AB 496

In a move to bolster consumer safety, California is enhancing its regulations governing cosmetics with the introduction of Assembly Bill 496 (AB 496). This law updates the state’s 2020 Toxic-Free Cosmetics Act, which initially banned 24 chemicals from use in personal...

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MoCRA Updates

MoCRA Updates

On Friday, Sep. 15, 2023, the FDA posted draft screenshots of the electronic submission portal – Cosmetics Direct – that will enable companies to organize and compile information needed to file facility registration and product listing submissions come Oct. 2023....

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MoCRA Updates

MoCRA Updates

To facilitate cosmetic product facility registration and product listing submissions as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA intends to make a new electronic submission portal available in October 2023. Although, FDA...

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Getting prepared for MoCRA by Dec. 29, 2023

Getting prepared for MoCRA by Dec. 29, 2023

With the upcoming deadline for complying with MoCRA requirements quickly approaching, it is important for beauty brands to undertake certain actions in order to be prepared. A few changes that MoCRA necessitates include mandatory registration of cosmetic facilities...

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Proposed Cosmetic Ingredient Updates

Proposed Cosmetic Ingredient Updates

Health Canada has proposed updates to the Cosmetic Ingredient Hotlist and the consultation has now been posted for comments until 11 October 2023.  The proposed updates include additions to the Hotlist as well as revisions to some existing entries including...

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