BioReg experts can review your product labeling and claims and inform you on registration requirements in the target market worldwide.
The first step for the manufacturers planning to register or market a product as a veterinary medical device would be to ensure that the product does not achieve its principal intended action by pharmacological, immunological or metabolic means.
Besides assessing the principal intended action (primary mode of action), a regulatory agency will usually evaluate other characteristics of the products to decide whether it is veterinary medicine or a medical device for animals. For example, if the product is labeled for prescription use and the indications for use include serious medical conditions, the regulators may be inclined to define such a product as a veterinary medicine.
Some regulatory agencies will define a medicinal product as any substance with a pharmacological effect on physiological function at the dosage used, irrespective of the presence or absence of claims in the product packaging or literature.
Once you have established that the product is indeed a medical device, and the regulatory agency concurs with your opinion, the road to the EU and other markets is almost straightforward, assuming the product is safe and properly labeled.
See our blog on veterinary products
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