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Uqeqesho lwe-Hitec Medical MDR – kwezobuGcisaDintshukumoRizixhobo eziphantsi kwe-MDR(Icandelo 2)

Iimfuno zovavanyo lweklinikhi phantsi kwe-MDR

Uvavanyo lonyango: Uvavanyo lweklinikhi kukuqokelela, ukuvavanywa, kunye nokuhlalutya kwedatha yeklinikhi ngokusebenzisa indlela eqhubekayo nesebenzayo, usebenzisa idatha yeklinikhi eyaneleyo ukumisela ukuthotyelwa kweemfuno ze-GSPR ezifanelekileyo.

Uphando lwezonyango: Ukuqhuba uphando olucwangcisiweyo lweesampuli zabantu ukuvavanya ukusebenza kunye nokhuseleko lwezixhobo zonyango.

I-PMS: Uphononongo lwentengiso yeposi:Ibhekisa kuyo yonke imisebenzi eyenziwa ngabavelisi kunye nabanye abaqhubi bezoqoqosho ngentsebenziswano, ngenjongo yokuseka nokugcina iinkqubo ezicwangcisiweyo zamva nje zokuqokelela ngokuqhubekayo kunye nokushwankathela amava afunyenwe kwizixhobo eziye zaqaliswa kwaye zikhoyo okanye zisetyenziswa kwintengiso, kunye nokuqinisekisa ukuba amanyathelo ayimfuneko okulungisa kunye nokuthintela kufuneka aqondwe.

I-PMCF: Ulandelelwano lwezonyango lwasemva kwemarike:Indlela kunye nenkqubo yokuqokelela kunye nokuvavanya idatha yeklinikhi ekusebenzeni kwesixhobo kunye nokhuseleko.Njengenxalenye yamaxwebhu obugcisa, i-PMCF iqhagamshelwe kwaye isetyenziselwa ukuhlaziya isicwangciso se-PMS kunye ne-CER.Isenokusetyenziswa njengethempleyithi yeengxelo ze-PMCF.

Inqaku le-MDR le-10:Abavelisi baya kuqhuba uvavanyo lweklinikhi ngokuhambelana neemfuno zeSiqendu 61 kunye neSihlomelo XIV, kubandakanywa nokulandelela i-PMCF ye-post market clinical.

Inqaku le-MDR le-61: Ukuqinisekiswa kokuthotyelwa kokhuseleko olusisiseko kunye neemfuno zokusebenza kufuneka zisekelwe kwidatha yeklinikhi, kunye nedatha evela kwi-PMS yokuhlola i-post market.Abavelisi kufuneka baqhube uvavanyo lwezonyango ngokwesicwangciso kwaye benze amaxwebhu abhaliweyo.

Inqaku le-MDR 54:Kwizixhobo ezithile zeKlasi III kunye ne-IIb, ibhodi eyazisiweyo iya kuphumeza inkqubo yokubonisana novavanyo lweklinikhi:

Izixhobo ezifakelwayo zeClass III

Izixhobo ezisebenzayo ze-IIb ezithi zisuswe emzimbeni womntu okanye zilawulwe kumzimba womntu ngendlela enokuba yingozi.

Ezi meko zilandelayo azifuni inkqubo yovavanyo lonyango:

1. Ukuhlaziya izatifikethi ngokwemigaqo ye-MDR;
2. Ukuguqulwa kweemveliso esele zithengisiwe ngumenzi ofanayo.Olu hlengahlengiso aluchaphazeli umngcipheko wenzuzo yesixhobo;
3. Kukho i-CS echaphazelekayo kwaye iqumrhu elaziswayo liqinisekisile ukuthotyelwa kwecandelo kuvavanyo lweklinikhi kwi-CS.