VETERINARY USE

the situation of veterinary medical devices in France

 

“there is no category of medical devices in animal health. These products fall within the regulatory framework of the veterinary medicinal product only when they meet the definition of a veterinary medicinal product. Otherwise, to the best of our knowledge, there are no regulations applicable to these "non-VMP medical device" products. Consequently, if these products are not considered as veterinary medicinal products, its do not require a marketing authorization or specific import certificate.

According to the following information (provided as an example):

 

Examples of animal care products in the following table do not meet the definition of a VMP, and the listed claims are not therapeutic.

 

Animal Care Products

Intended Uses

Wound moistening and barrier gel

Create a physical barrier from external contamination while maintaining a moist environment on wound surfaces.

Ocular irrigation solution

Mechanically irrigate eyes to remove debris and contaminants that cause eye irritations and discomfort.

Otic irrigation solution

Flush the ear canal to remove deposits that cause ear irritations and discomfort.

Wound irrigation solution

Clean wounds by mechanically flushing out contaminants on wound surfaces.  May contain ancillary antimicrobial function to reduce the possibility of irrigation solution contamination.

 

Consequently, according to these elements, there would be no specific procedure for importing these products in France.

 

 

these veterinary products do not meet the definition of a VMP per presentation. Indeed, the claims are not therapeutic. Consequently, according to these elements, there would be no specific procedure for importing these products in France.”

 

From:

Département Inspection et Surveillance du Marché

Agence Nationale du Médicament Vétérinaire (ANMV) / Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (Anses)

8 rue Claude Bourgelat - Parc d'activités de la Grande Marche - Javené –CS 70611

35306 Fougères – France