Borderline Products & Switches
Borderline products are products whose status is not well defined because of their presentation, their function, or even their mode of action.
A switch is a change of a product’s status, either following a requalification by the Competent Authorities, or following the decision of the operator. Therefore, a medical device can be re-qualified in to a medicinal product if there is a pharmacological, immunological, or metabolic primary mode of action and a cosmetic product or a food supplement can become a medical device as soon as the applicant proves the legitimacy of a medical indication and that the mode of action of the product is not that of a medicinal product.
WHITE-TILLET advises and assists you to:
- Determine the status of your borderline product
- When it being a switch product :
- Develop the product development plan;
- Prepare the technical file;
- Follow the procedure and assists you with the authorities.
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