by Srishti Chaudhari | Nov 30, 2023 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices
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...
by Srishti Chaudhari | Nov 30, 2023 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices
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...
by Srishti Chaudhari | Aug 2, 2023 | Canadian Quality Assurance, Canadian Regulatory, Cosmetics
The ban on animal testing for cosmetics has introduced several important requirements for manufacturers and brand owners. While most cosmetics do not necessitate the submission of safety evidence, it is the responsibility of the manufacturer or brand owner to ensure...
by Srishti Chaudhari | Aug 1, 2023 | Canadian Quality Assurance, Canadian Regulatory, Environment and Climate Change Canada
A recently published mandatory survey under CEPA paragraph 71(1)(b) requires that industry report certain information related to substances listed in the notice no later than January 17, 2024. The stated purpose is to support the government’s prioritization...
by Sagarika Sharma | Jun 27, 2023 | Canadian Quality Assurance, Canadian Regulatory, Importation of NHPs, Natural Health Products
Currently in Canada, there are no Health Canada fees charged in relation to Natural Health Products (NHPs). In May 2023, Health Canada proposed implementing cost recovery fees to enhance regulatory oversight and streamline the approval processes for NHPs. The proposed...
by Delsie Braganza | Jun 21, 2023 | Canadian Quality Assurance, Canadian Regulatory, Environment and Climate Change Canada
Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), the legislation amending the Canadian Environmental Protection Act (CEPA) has been recently passed by the Senate. This bill was first introduced last year to modernize CEPA since its...
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