General medical devices
We review classification based on intended use and risk, then advise on submission routes and documents for the target country.
Services
Medical devices, food and cosmetics
US & Canadian regulatory support
From product classification to regulatory compliance, we support you at every step of the US and Canadian regulatory process.
Even if you are unsure of your product's classification, our consultation helps you find the most suitable regulatory pathway.
MEDICAL DEVICES
Medical devices, diagnostics & beauty devices
Requirements vary by country and device classification. We first assess whether your product is a medical device and its classification, then identify the submission route and supporting documents.
In vitro diagnostics (IVD)
We assess test purpose, specimens and use settings, and define the scope of performance-data and labeling review.
Digital medical devices
We assess software functionality and intended medical use, and review classification and required technical documentation.
Beauty devices
Based on how the product works and its labeling and advertising claims, we assess whether it is regulated as a medical device and which requirements apply.
Radiation-emitting electronic products
We identify applicable standards and reporting requirements based on emission characteristics and intended use, and help prepare documentation.
Applicable requirements and the scope of support are confirmed after an initial review.
FOOD & INGREDIENTS
Food, ingredients & packaging
For each product, we check whether ingredients are permitted, whether labeling complies and whether facility or process registration is required.
General food & beverages
We review product type, manufacturing and import arrangements, ingredients, labeling and registration requirements.
Specialized adult nutrition products
We assess the intended users and purpose, then define the scope of classification and labeling or advertising review.
Novel foods & ingredients
We assess use history and manufacturing characteristics to determine whether additional safety review or pre-market steps are needed.
Food additives & colors
We check permitted uses and conditions based on the ingredient's purpose and level of use.
Supplemented foods
We review added ingredients and their levels, product classification and labeling requirements.
Acidified & low-acid canned foods
We assess product and process characteristics and review applicable registration and process-filing requirements.
Food-contact materials & packaging
We assess materials and conditions of use, documentation supporting food-contact suitability and applicable procedures.
Authorities and procedures differ by country and product. Not every product requires pre-market approval.
Applicable requirements and the scope of support are confirmed after an initial review.
COSMETICS & HEALTH PRODUCTS
Cosmetics, OTC & health products
Ingredients and claims can change a product's classification as a cosmetic, OTC drug or natural health product (NHP). We confirm classification first, then determine the appropriate registration, notification or authorization route.
General cosmetics
We review ingredients and English labels and support applicable processes, including US MoCRA facility registration and product listing, and Canadian CNF notification.
Work is performed within the agreed scope, from classification and applicability checks to documentation, registration, notification and follow-up responses.
Clients provide French labeling for Canada. French translation and review are not included.
Nonprescription drugs (OTC)
We classify products based on ingredients and claims and review applicable standards, including OTC monographs, and country-specific procedures.
We check whether the product is a nonprescription drug or NHP and identify documentation and labeling requirements.
Dietary supplements & natural health products
We assess ingredients and intended use, country-specific classifications such as dietary supplements and NHPs, and ingredient and labeling requirements.
We identify applicable notification or authorization procedures and establishment requirements and help prepare documents within the agreed scope.
Classification and procedures vary by country. Registration or notification does not mean product approval.