Authorised Representative:
"authorised representative" means any natural person, resident in the Republic of
South Africa, who has the written mandate to represent a manufacturer, importer,
distributor, wholesaler, retailer or service provider in the Republic and to act on his or her behalf for specified tasks with regard to the latter's obligations and who has submitted an application for the registration of a medical device or IVD and in whose name the manufacturer licence, wholesaler licence and or certificate of registration is issued. The authorised representative is responsible for all aspects of the medical device or IVD, including quality, safety and compliance with conditions of registration.
Holder of a Certificate of Registration (HCR): means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medical device or IVD, including quality and safety and compliance with conditions of registration.
Application: One who submits the registration application for medical device or IVD.
AR: Can only register products on behalf of Manufacturer, Distributor or Importer.
He can be the HCR and Applicant.
Scenario I: A is a domestic manufacturer and distributor. So in this case, A is the AR, HCR and Applicant.
Scenario II: A is the foreign manufacturer. B is the local AR. So the registration will be done by B. B is also HCR and Applicant.
Regards,
Sreenu