Each premise where medical devices are stored or trade activities for medical devices are conducted, with the exception of those companies who solely supply non-sterile, non-measuring Class A device which have been deemed exempt.
The type of license that you will need will depend on the activities that you are performing. If you are doing any packaging, labelling, servicing or refurbishment of medical devices at the establishment, you will be required to apply for a Manufacturer’s license. If you are doing any distribution activities, such as importation or exportation of medical devices to and from the premise, you will be required to apply for a Distributor’s license. If you are doing any wholesaling activities, such as sale, storage, transportation and/or the onward dispatch of medical devices from the premise, you will be required to apply for a Wholesaler’s license.
