MDSAP: What Is It and How Does It Apply to my Medical Device?
Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These
... 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
... Read moreBenefits of Using a Third-Party Auditor for Your Canna Facility
In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or regulatory framework requirements. While audits have received negative stigma and are commonly dreaded, if performed properly and regularly, audits are useful tools to make sure that compliance is consistently and effectively implemented throughout all canna
... Read moreHealth Canada Consultation on New Feeds Regulations
On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize the Feeds Regulations, 1983. The consultation to obtain feedback from the public will close on September 10, 2021. The pre-published proposed regulations are currently posted in the Canada Gazette, Part I for individuals to read
... Read moreAnimal Supplements in the USA
Animal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) confirms that the DHSEA does not apply to animal
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