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MoCRA REMINDER!

MoCRA REMINDER!

As 2024 has kicked off, the FDA has geared up to enforce its MoCRA requirements for cosmetics. The extended deadline for facilities to submit cosmetic facility registrations and product listings on the FDA Cosmetics Direct portal continues to be July 01, 2024. If your...

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The DEL and MDEL renewal season is here! 

The DEL and MDEL renewal season is here! 

All DEL and MDEL holders, please be reminded that the deadline to submit your renewal applications this year is Mar. 31, 2024, in order to ensure compliance with regulatory requirements and continue with licensable activities. This process involves an annual fee...

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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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