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{
    "id": 1494072,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494072/?format=api",
    "text_counter": 509,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": "Registration of 59A. (1) An application for registration of a medical devices medical devices establishment shall be submitted to the Authority in the prescribed establishment. format and shall be accompanied by the prescribed fees. (2) An importer, distributor or dealer will establish a system of notification of field safety corrective action and shall notify the Authority of such system. (3) Where the Authority is satisfied that the application under subsection (1) meets the prescribed requirements, the Director-General shall issue a registration certificate for the medical devices establishment in the prescribed format. (4) A medical devices establishment registration certificate issued under this section shall be valid for a period of one year, renewable annually upon application in accordance with the prescribed conditions. (5) The registration certificate for manufacturers shall be valid for five years following a successful reinspection. (6) The Authority may refuse to issue a medical devices establishment registration certificate where— (a) an applicant has made a false or misleading statement in the application; (b) the Authority has reasonable grounds to believe that issuing the medical devices establishment registration certificate will constitute a risk to the health or safety of patients, users or other persons; or (c) an applicant has failed to meet the prescribed conditions for medical devices establishment registration."
}