Pa 28th .Epulo 2022, Joytech adalandira koyamba ku EU MDR kwa oyang'anira athu osasokoneza kuthamanga kwa magazi, mutha kudziwa zambiri Pano.
Mu 2023, ma thermometers olumikizana ndi Joytech, ma thermometer osalumikizana ndi zowunikira zatsopano za kuthamanga kwa magazi zonse ndizovomerezedwa ndi EU MDR.
CE (MDR) ndi chiyani?
Zikafika pa satifiketi ya CE, aliyense amadziwa.Pafupifupi makampani onse ali ndi certification ya CE.MDR ndiye chidule cha European Medical Device Regulation, yomwe ndikusintha kwa CE (MDD) ndipo imayika zofunika kwambiri pachitetezo ndi magwiridwe antchito a zida zamankhwala.Timachitchanso CE (MDR).
Kodi pali kusiyana kotani pakati pa CE (MDD) ndi CE (MDR)?
MDR ndi lamulo ndipo MDD ndi chitsogozo.Chifukwa ndikukweza, kuchokera ku malangizo kupita ku malamulo, mayiko omwe ali m'bungwe la EU azikhala ndi ulamuliro wokhwima pamayendedwe ndi zotsatira zake.
Zikuwonekera kwambiri m'mbali zotsatirazi:
1) Kulimbitsa maudindo a wopanga.
a) Wopanga akuyenera kukhala ndi woyang'anira wosachepera m'modzi yemwe ali ndi luso pazida zamankhwala (palibe chofunikira mu malangizo a MDD);
b) Wopangayo azikhazikitsa ndikusintha mosalekeza zolembedwa zaukadaulo ndikuwonetsetsa kuti zikupezeka ngati afunsidwa ndi akuluakulu adziko.
c) Opanga akuyenera kuyankha pakuwunika kosadziwika ndi mabungwe odziwitsidwa nthawi iliyonse kuti awonetsetse kuti zikalata zaukadaulo ndi kukonza dongosolo;(Zogulitsa za Class II)
d) Pazinthu zomwe zili pachiwopsezo chachikulu chamakampani ogulitsa, zimakhala zovuta kufunsira CE.
2) Kuchulukitsidwa kwazinthu zowongolera komanso kuwunika kwa ziphaso zolimba.
a) Kuwonjezeka kwa malamulo a magulu: kuchokera ku 18 mu MDD mpaka 22 mu MDR;
b) Zofunikira zofunika pamndandanda wazowonjezera: kuchokera ku zinthu 13 mu MDD kupita ku zinthu 23 mu MDR;
c) Mapangidwe a zikalata zaukadaulo za CE asintha ndipo amagawidwa kukhala: zolemba zaukadaulo wazogulitsa ndi zikalata zotsatsa pambuyo pa malonda (MDD imangofunika zikalata zaukadaulo wazinthu);
d) Lipoti lachipatala.MDR imafuna makampani kuti apereke mtundu wachinayi wa malipoti owunika zachipatala, omwe ndi okhwima kuposa mtundu wachitatu;
3) Kuchulukitsa kwa ntchito
a) MDD imangoyang'ana zinthu zachipatala, pomwe MDR imaphatikizapo zida zina zomwe si zachipatala pazomwe zikugwiritsidwa ntchito, monga ma lens a masamba, zokongoletsa, ndi zina;
b) Mu MDD, zida zogwiritsidwanso ntchito zimayikidwa ngati gulu la zida zachipatala ndipo sizimafuna kulowererapo kwa bungwe lodziwitsidwa, pamene MDR imafuna bungwe lodziwitsidwa kuti liwonetsetse kugwirizanitsa kwa zipangizo zopangira opaleshoni;
4) MDR imafuna kuwonekera kwambiri komanso kufufuza
a) Tinayambitsa UDI yozindikiritsa zida zapadera kuti ziwonjezeke kutsatiridwa;
b) Zambiri zokhudzana ndi kampaniyo zidzasonkhanitsidwa ku European Medical Device Database (EUDAMED);
c) Kukhazikitsa njira yoyang'anira pambuyo pa msika (PMS);
d) Bungwe lodziwitsidwa lidzachita kuyendera mosadziwitsidwa.
Kodi kuwunika kwachipatala kwa MDR CE ndi chiyani?
Mchitidwe wachipatala womwe tikukamba nthawi zambiri umagawidwa m'mitundu iwiri:
a) Mayesero azachipatala amagwiritsidwa ntchito kwa anthu kuti apeze deta kuti atsimikizire chitetezo cha mankhwala.
b) Malipoti achipatala makamaka amatsimikizira chitetezo ndi mphamvu ya mankhwala pogwiritsa ntchito kuyerekezera zinthu (kuchokera m'mbali zitatu: deta yachipatala, zofunikira zaumisiri, ndi momwe chilengedwe chimagwirira ntchito), kusanthula deta, ndi kubwereza mabuku.
c) Lipoti lowunika zachipatala ndi gawo la chikalata chaukadaulo cha CE komanso ndichinthu chofunikira kwambiri (lipoti lowunika zachipatala ndi lipoti lofunikira mu chikalata chaukadaulo cha CE mukafunsira chiphaso cha CE).
d) Pakalipano, ndondomeko yachinayi ya lipoti lachipatala lachipatala likugwiritsidwa ntchito, lomwe ndi lipoti la kafukufuku wachipatala lomwe linapangidwa motsatira ndondomeko yowunika zachipatala MedDev 2.7.1.
Kudutsa chiphaso cha MDR kumatanthauza kuti Joytech blood pressure monitor ndi Digital thermometer yafika pamiyezo yokhazikika pamapangidwe, kupanga ndi kuwongolera bwino, ndipo imatha kupereka zida zamankhwala zotetezeka komanso zodalirika kwa ogwiritsa ntchito padziko lonse lapansi.
Joytech blood pressure monitor and digital thermometer alandira chitamando chimodzi kuchokera kwa ogwiritsa ntchito chifukwa cha zotsatira zolondola zoyezera, kapangidwe kake kosavuta kugwiritsa ntchito komanso magwiridwe antchito abwino kwambiri.Tsopano, adutsa chiphaso cha MDR, chomwe mosakayikira chidzakulitsa chidaliro ndi kukhutira kwa ogwiritsa ntchito pazinthu zathu.
Joytech Healthcare ipitiliza kudzipereka pakupereka zida zamankhwala zapamwamba komanso zomwe zimathandizira ku thanzi la ogwiritsa ntchito padziko lonse lapansi.Tikukhulupirira kuti chifukwa cha khama lathu, zinthu zathu zabwino zidzakuthandizani kukhala ndi moyo wathanzi pamsika wapadziko lonse lapansi.
Ngati muli ndi mafunso kapena zofunikira pazathu zowunikira kuthamanga kwa magazi ndi zida za thermometer, chonde omasuka kutilankhula.
