Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process has two purposes, the first is to verify that the MDL will remain active and will continue to be sold in Canada. The second reason is to collect and analyze the appropriate information before invoicing
... Read more5 reasons why Drug Identification Numbers are Important
Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product is marketed in Canada. A DIN is a unique, computer-generated, eight-digit number issued to the manufacturer and printed on the front of package labels. A DIN identifies the following product characteristics: manufacturer; product name; active
... Read more5 Reasons Why Food Labelling Is Important for Your Business
Have you ever looked at a food label and wondered why all that information is there? Labels do more than just list ingredients. They play a critical role in ensuring compliance with Health Canada and FDA regulations, preventing legal issues, and keeping products on the market. They also help identify allergens, verify nutrition claims, and
... Read moreHealth Canada’s Annual Adjustment of Fees for Drugs & Medical Devices
On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices in the Canada Gazette, Part I. Each year Health Canada’s fees for drugs and medical devices are subject to an annual fee adjustment. The fee adjustment is a cost-recovery practice by the federal government. Cost recovery
... Read moreWhat You Need to Know – Software as a Medical Device (SaMD)
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes more available, there appears to be a shift with regard to how work is carried out across several industries. Within the last decade, the healthcare field has seen an increased amount of software being utilized
... Read moreImportant Notice Regarding the Transition of COVID-19 Site Licenses
In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product
... Read moreConsultation Period Extension: Proposal to Improve Natural Health Product Labelling
On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada held extensive pre-consultation with a wide array of stakeholders in the development of the policy and prior to publication in Canada Gazette, Part I. The Canada Gazette, Part I consultation period process allows all stakeholders
... Read moreProposal to Improve Natural Health Product Labelling
On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. The proposed changes would directly affect natural health product (NHP) labelling requirements. What are Natural Health Products? As defined by Health Canada, natural health products are naturally occurring substances that are used to restore or
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