Health Canada Regulatory Expert Needed - Red Light Therapy

We are looking for an experienced Canadian regulatory affairs consultant with expertise in Health Canada regulations for medical, wellness, and/or light therapy devices. We are a U.S.-focused red light therapy brand that manufactures and sells red and near-infrared light therapy products. Our products are marketed primarily for applications including sports recovery, pain management, wellness, and related uses. While the United States is our primary market, we currently sell and ship products to customers in Canada through both: * B2C: Direct-to-consumer ecommerce sales * B2B: Healthcare professionals, clinics, wellness centers, and other professional customers We need an expert to assess our current Canadian sales model and determine exactly what regulatory requirements apply to us under Health Canada regulations. Key Questions We Need Answered We are specifically looking for guidance on: * How Health Canada would classify our red light therapy products. * Whether our products would be considered medical devices in Canada, and if so, what device class would apply. * Whether a Medical Device Licence (MDL) is required for our individual products. * Whether a Medical Device Establishment Licence (MDEL) is required and which party would need to hold it. * What requirements apply to us as a foreign manufacturer selling directly from outside Canada. * Whether we need a Canadian importer, distributor, regulatory representative, or other local entity. * Whether the requirements differ when selling directly to consumers versus healthcare professionals/clinics. * What requirements apply when products are shipped directly from the U.S. to Canadian customers. * Whether our current product labeling, packaging, instructions, website claims, and marketing materials require changes for the Canadian market. * Any applicable requirements regarding English/French labeling. * Whether there are restrictions on the types of therapeutic or health claims we can make in Canada. * What registrations, licences, quality-system requirements, documentation, or other compliance measures we need to complete before continuing or expanding sales in Canada. * Any other Health Canada requirements or regulatory risks that we should be aware of. Deliverable We are not simply looking for general regulatory information. We would like the consultant to review our specific situation and provide us with a clear, practical compliance roadmap explaining: 1. How our products are likely to be classified in Canada. 2. Which licences, registrations, or approvals are required. 3. Which entity needs to obtain each licence or registration. 4. What documentation and quality-system requirements apply. 5. What changes, if any, are required to our packaging, labeling, website, and marketing claims. 6. The steps required to become fully compliant. 7. Expected timelines and approximate government/regulatory costs. 8. Whether we can continue selling into Canada while any required applications are being completed. Ideal Candidate We are specifically looking for someone with direct experience in: * Health Canada medical device regulations * Medical Devices Regulations (SOR/98-282) * Medical Device Licences (MDL) * Medical Device Establishment Licences (MDEL) * Class I and Class II medical devices * Foreign manufacturers selling into Canada * Medical/wellness devices * Red light therapy, photobiomodulation, laser/light therapy, rehabilitation, physiotherapy, or similar devices would be a major advantage * Canadian labeling and advertising/health-claim requirements Please do not apply if your experience is primarily with U.S. FDA regulations. We specifically need someone with hands-on Canadian/Health Canada regulatory experience. When Applying Please briefly describe: * Your experience working with Health Canada medical device regulations. * Examples of similar products or companies you have advised. * Your experience with Class I/Class II device classification and MDL/MDEL requirements. * Whether you have experience representing or advising foreign manufacturers entering the Canadian market. * Your proposed approach to this project. * Your estimated timeframe for completing the initial regulatory assessment. We are looking to begin as soon as possible.