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SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA

Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada.

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Biden Administration Unveils Long-Awaited COVID-19 Rules For Large Employers and Healthcare Workers

Health Law RX

An employee is considered “fully vaccinated” two weeks after completing primary vaccination with a COVID-19 vaccine with, if applicable, at least the minimum interval between doses as recommended by the CDC, World Health Organization (“WHO”), or if administered as a part of a clinical trial. Positive Test Results. Notice to Employees.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic. The inspection resulted in a non-compliant rating.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

ISO/IEC 42001 , the world’s first AI management system standard, meets that need. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. More than ever, businesses today need a framework to guide them on their AI journey.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

Time frame for Accepting CE Marked Medical Devices in Great Britain Extended, 01 July 2023 The United Kingdom (UK) government has made regulations ( The Medical Devices (Amendment) (Great Britain) Regulations 2023 ) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.

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