The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.
Canada’s food regulations ensure they have one of the safest food supplies in the world. They are always looking forward to understanding and acting according to the changes or emerging trends in the food sector that may affect how or what they regulate. Currently, Health Canada (HC) is planning to consult with Canadians on modernizing the food regulations. The agenda is to keep the food regulations in pace with the changes driven by:
Labeling is a vital aspect when it comes to marketing the cosmetic products as it helps consumers understand accurate details of the product. In Canada, cosmetics and personal care products are regulated by Health Canada (HC). Cosmetic labeling is regulated by the Food and Drugs Act, the Cosmetic Regulations, and the Consumer Packaging and Labeling Act and Regulations.
It is mandatory to display the following details on a cosmetic label in Canada:
The ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising or promotional material before its dissemination in Canada. The Pharmaceutical Advertising Advisory Board (PAAB) is an organization whose advertising pre-clearance service for healthcare professionals is recognized by Health Canada.
Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibility of generic products.
On December 14, 2016, Health Canada published revisions to nutrition labeling, food color requirements, and the list of ingredients of the Food and Drug Regulations. The revisions intended to help Canadians easily understand the nutritional facts and list of ingredients to make informed choices. The major revisions include the following:
A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.
Mexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America. The Medical devices marketed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), and the regulations are both stringent and complex.
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.