EUA FDA Transition Plan for Medical Devices in 2022

In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations (EUA). This measure by the FDA was designed to mitigate the stress on the device supply chain and the associated scarcity of certain devices that are critical to the prevention and management of Covid-19. So
... Read moreYour Health Canada eMCE Update For 2022

Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification that their medical devices can be marketed in Canada and meet Canadian regulations. As a service to the Canadian medical industry, Health Canada through the Regulatory Operations and Enforcement Branch (ROEB) issues these certificates to
... Read moreHow Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS

In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be distributed in the Canadian market. Drugs include both prescription and non-prescription pharmaceuticals; biologically derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals. Natural health products,
... Read moreEnd of DEL transition period for Hand Sanitizers

In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested by the World Health Organization (WHO) to fight and stay safe from COVID-19. Adaptation of effective hand hygiene is vital, as advised by WHO to wash or sanitize your hands frequently with soap or >60%
... Read moreRegistering Products with the EPA – What You Need to Know

The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is a combination of scientific, legal, and administrative procedures through which the EPA examines the ingredients of the pesticide the site or crop where it is to be used the amount, frequency, and timing of its
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