Uqeqesho lwe-Hitec Medical MDR – Inkcazo yeMigaqo ye-MDR

Isixhobo sezonyango

Ibhekisa kuso nasiphi na isixhobo, isixhobo, isixhobo, isoftwe, implanti, into esetyenziswayo, imathiriyeli, okanye enye into esetyenziswa kuphela okanye idityaniswe ngumvelisi ngeenjongo zonyango ezikhethekileyo kumzimba womntu:

• Ukuxilongwa, ukuthintela, ukubeka iliso, ukuxela kwangaphambili, ukuxilongwa, unyango okanye ukuxolelwa kwezifo;
• Ukuxilongwa, ukubeka iliso, unyango, uncedo, kunye nembuyekezo yokulimala okanye ukukhubazeka;
• Uphononongo, ukutshintshwa, kunye nolawulo lweenkqubo ze-anatomical, physiological, okanye pathological or states;
• Ukubonelela ngolwazi ngovavanyo lwe-in vitro lweesampulu ezivela emzimbeni womntu, kubandakanya amalungu, igazi, kunye nezicubu ezinikezelweyo;
• Ukusetyenziswa kwayo kufumaneka ikakhulu ngokusebenza ngokomzimba kunye nezinye iindlela, kungekhona nge-pharmacology, i-immunology, okanye i-metabolism, okanye nangona ezi ndlela zibandakanyeka, zidlala indima yokuncedisa kuphela;
• Izixhobo ezineenjongo zolawulo okanye inkxaso
• Ngokukhethekileyo isetyenziselwa ukucoca, ukubulala iintsholongwane, okanye izixhobo zokubulala iintsholongwane.

Isixhobo esisebenzayo

Nasiphi na isixhobo esisebenza njengomthombo wamandla ngaphandle kokuxhomekeka kumzimba womntu okanye umxhuzulane, kwaye sisebenza ngokutshintsha ukuxinana kwamandla okanye ukuguqula amandla.Izixhobo ezisetyenziselwa ukuhambisa amandla, izinto, okanye ezinye izinto phakathi kwezixhobo ezisebenzayo kunye nezigulane ngaphandle kotshintsho olubalulekileyo aziyi kuqwalaselwa njengezixhobo ezisebenzayo.

Isixhobo esihlaselayo

Nasiphi na isixhobo esingena emzimbeni womntu ngemijelo yendalo okanye umphezulu.

Ipakethi yenkqubo

Indibaniselwano yeemveliso ezipakishwe kunye kwaye zithengiswe ngeenjongo ezithile zonyango.

Umenzi

Umntu wendalo okanye osemthethweni owenza okanye ohlaziya ngokupheleleyo isixhobo okanye isixhobo esiyilwe, esenziwe, okanye esihlaziywe ngokupheleleyo kwaye athengise isixhobo phantsi kwegama laso okanye uphawu lwaso.

Ukuhlaziya ngokupheleleyo

Ngokusekwe kwingcaciso yomenzi, ibhekisa kuhlaziyo olupheleleyo lwezixhobo ezithe zafakwa kwimarike okanye zasetyenziswa, okanye ukusetyenziswa kwezixhobo ezisetyenzisiweyo ukwenza izixhobo ezitsha ezithobela lo mmiselo kwaye zinike izixhobo ezihlaziyiweyo ubomi obutsha. 

Ummeli ogunyazisiweyo

Nawuphi na umntu wendalo okanye osemthethweni ochongiweyo ngaphakathi kwe-EU ofumana kwaye amkele isigunyaziso esibhaliweyo kumenzi ongaphandle kwe-EU ukuba athathe onke amanyathelo egameni lomvelisi ngokuhambelana nezibophelelo ezibekwe ngulo Mmiselo kumenzi.

Umrhwebi

Nawuphi na umntu wendalo okanye osemthethweni ochongiweyo kwi-European Union obeka izixhobo ezisuka kumazwe esithathu kwimarike ye-EU.

Abasasazi

Nawuphi na umntu wendalo okanye osemthethweni kumboneleli, ngaphandle komvelisi okanye ongenisa impahla ngaphandle, angasibeka esi sixhobo emarikeni de sisetyenziswe.

Ukuchongwa kwesixhobo esisodwa (UDI)

Uthotho lweempawu zamanani okanye zealphanumeric ezenziwe ngokuchongwa kwesixhobo esivunyiweyo kwihlabathi kunye nemigangatho yekhowudi, evumela ukuchongwa okucacileyo kwezixhobo ezithile kwimarike.