Your Cosmetic Notification MAY get Qualified for processing in 24 hours!
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, of skin, hair or teeth, and includes deodorants or perfumes.” This is different than drug and natural
... Read moreNatural Health Products Quality Characterization Guide for 2022
Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality of your NHPs. Introduction The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health Products Regulations (NHPR) and meet the quality requirements. Product license holders are
... Read moreTop 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), have come together to identify 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). The goal of GMLP is to help promote safe, effective,
... 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 moreFDA Qualified Health Claim for Magnesium 2022
The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or object to some qualified health claims regarding magnesium and the reduced risk of high blood pressure (hypertension), so long that the claims are worded properly to avoid misleading the consumer. The claims are essentially accompanied
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