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{
    "id": 1492388,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1492388/?format=api",
    "text_counter": 247,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": " Hon. Temporary Chairman, I beg to move: THAT, Clause 58 of the Bill be amended— (a) in sub-clause (2) by inserting the phrase “in accordance with the most recent World Health Organisation’s prescribed guidelines on good manufacturing practice” immediately after the word “Authority”; (b) by inserting the following new sub-clauses immediately after sub- clause (2)— “(3) The Authority shall receive from the Kenya Nuclear Regulatory Authority established under the Nuclear Regulatory Act, 2019 documented evidence of radiation required to enable a medical device perform its therapeutic and diagnostic functions and the intended purpose of the device, for issuance of a registration certificate for a medical device. (4) An importer, distributor or dealer shall establish and implement documented procedures for the maintenance of importation or distribution records and shall maintain an importation or distribution record of each medical device to be submitted to the Authority.” Hon. Temporary Chairman, on Clause 58 we have amendments in (a) and (b). I do not know whether I can prosecute all of them together or?"
}