Marketing Authorisation for a Medicinal Product

Certificates of Free Sale for medical devices are issued by a European Competent Authority, upon request by a manufacturer or an authorised representative. These Certificates verify that a medical device may be legally marketed in Malta and in the European.

Legislation

Medicines Act

Information

Information on Marketing Authorisation for a Medicinal Product.

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Application

Application form for Marketing Authorisation for a Medicinal Product.

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Competent Authority

Medicines Authority

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last updated June 2026

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