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{
"id": 1494125,
"url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494125/?format=api",
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"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "(ii) permanent or temporary changes to the labelling or instructions for use; (iii) software upgrades including those carried out by remote access; (iv) modification to the clinical management of patients to address a risk of serious injury or death related specifically to the characteristics of the device; (v) device exchange; (vi) device destruction; or, (vii) advice given by product owner regarding the use of the device. “health product” includes a medicine, medical product, medicinal substance, vaccine, diagnostic, medical device, blood or blood product, herbal medicine, therapeutic feed and nutritional formulation, cosmetic and related products; “health technology” means the application of organised knowledge and skills in the form of medicines, devices, vaccines, procedures, and systems developed to solve a health problem and improve the quality of lives, and includes radiation-emitting devices and related products; “herbal medicine or product” means a plant derived material or preparations with claimed therapeutic or other health benefits, which contain either raw or processed ingredients from one or more plants or material of inorganic or animal origin and includes herbs, herbal materials, herbal preparations, finished herbal products that contain active ingredients, parts of plants or other plant materials or combinations; “Inspector of Drugs” means a person who is competitively recruited by the Authority as a drug inspector under this Act; “lot” or “sub-lot” means a defined quantity of starting material, packaging material or product, processed in a single process or series of processes so that the quantity is expected to be homogeneous; and in the case of continuous manufacture, the lot corresponds to a defined fraction of the production characterized by its intended homogeneity; “lot release” means the process of the evaluation of an individual lot of a licensed biological product by the Authority before giving approval for its release onto the market; “marketing authorisation” means the certificate of registration issued by the competent health product regulatory authority in the country of origin for the purpose of marketing or free distribution of a health product after evaluation for safety, efficacy and quality; “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of— (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
}