Canada is a highly attractive and stable market for pharmaceutical and medical device manufacturers, with strong demand for innovative healthcare products and a rigorous yet transparent regulatory framework.
Health Canada, through its Health Products and Food Branch (HPFB), regulates drugs, medical devices, biologics, and natural health products. All products require pre-market authorization (e.g., NDS/NOC, ANDS, MDEL, Class II–IV device licences), with strict requirements for safety, efficacy, and quality. While a Canadian authorized representative is not mandatory for most registrations, the procedural complexities, detailed documentation, and Health Canada review timelines can be challenging for foreign manufacturers. MedWisdom LifeScience specializes in guiding global companies through these intricacies, providing expert product classification, regulatory strategy, dossier preparation, and comprehensive support to ensure full compliance with Health Canada guidelines and achieve efficient, confident market entry in Canada.
Get Canada Compliance Support
Preparation and submission of Clinical Trial Applications (CTA/CTA-A) to Health Canada, including IND-equivalent support, protocol review, and regulatory follow-up.
Implementation of PMS plans, mandatory problem reporting (MPR), recall management, trend analysis, and ongoing compliance with Health Canada post-market obligations for drugs and devices.
Support for obtaining import/export licences, establishment licences (MDEL for devices), batch release documentation, and compliance with Health Canada importation/exportation requirements.
Review and approval preparation of advertising, promotional claims, and materials to ensure compliance with Health Canada’s Food and Drugs Act, PAAB, and Ad Standards guidelines.
Preparation and facilitation of Health Canada meetings (Pre-Submission, Type A/B/C, scientific advice), query responses, and direct liaison with reviewers for efficient approvals.
Partner with Medwisdom for expert, streamlined, and fully compliant regulatory support in Canada — from Health Canada submissions and product classification to clinical trials, post-market surveillance, and long-term market success.
Contact Our Canada Regulatory Experts