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Maphunziro a Hitec Medical MDR - Zolemba zaukadaulo pansi pa MDR (Gawo 2)

Zofunikira pakuwunika kwachipatala pansi pa MDR

Kuunika kwachipatala:

Kuunika kwachipatala ndiko kusonkhanitsa, kuyesa, ndi kusanthula deta yachipatala kudzera m'njira yosalekeza komanso yowonongeka, pogwiritsa ntchito deta yokwanira yachipatala.to kudziwa kutsatiridwa ndi zofunikira za GSPR.

Kafukufuku wachipatala:

Chitani kafukufuku mwatsatanetsatane wa zitsanzo za anthu kuti muwunikire magwiridwe antchito ndi chitetezo cha zida zamankhwala.

PMS (Post market surveillance):

Amatanthauza zochitika zonse zomwe opanga ndi ena ogwira nawo ntchito azachuma mogwirizana, ndi cholinga chokhazikitsa ndi kusunga njira zaposachedwa kwambiri zosonkhanitsira ndi kufotokoza mwachidule zomwe zachitika pazida zomwe zidakhazikitsidwa ndipo zikupezeka kapena kugwiritsidwa ntchito pamsika, ndikuwona ngati njira zowongolera ndi zodzitetezera ziyenera kumveka.

PMCF(Kutsata kwachipatala kwa post market):

Njira ndi njira yosonkhanitsira ndikuwunika mwachangu deta yazachipatala pakugwira ntchito ndi chitetezo cha chipangizocho.Monga gawo la zolemba zaukadaulo, PMCF imalumikizidwa ndikugwiritsa ntchito kukonza mapulani a PMS ndi CER.Itha kugwiritsidwanso ntchito ngati template ya malipoti a PMCF.

MDR Ndime 10:Opanga aziwunika zachipatala molingana ndi zofunikira za Article 61 ndi Zowonjezera XIV, kuphatikiza kutsatira kachipatala ka PMCF.

Ndime 61 ya MDR:Kutsimikizira kutsatiridwa ndi zofunikira zachitetezo ndi magwiridwe antchito kuyenera kuzikidwa pazachipatala, komanso deta yochokera ku PMS yowunika pambuyo pa msika.Opanga akuyenera kuwunika zachipatala molingana ndi mapulaniwo ndikupanga zikalata zolembedwa.

Ndime 54 ya MDR:Pazida zapadera za Gulu la III ndi IIb, bungwe lodziwitsidwa lidzagwiritsa ntchito njira yowunikira zowunikira:

Zida za Class III zoyika

IIb zida zogwira ntchito zomwe zimachotsedwa m'thupi la munthu kapena kuperekedwa ku thupi la munthu m'njira yowopsa.

Zinthu zotsatirazi sizifuna kuti munthu aziwunikidwa pachipatala:

Kukonzanso ziphaso molingana ndi malamulo a MDR;

Kusintha kwa zinthu zomwe zili kale pamsika ndi wopanga yemweyo.Kusintha uku sikukhudza chiwopsezo cha phindu la chipangizocho;

Pali ma CS oyenera ndipo bungwe lodziwitsidwa latsimikizira kuti likutsatiratiye gawo la kuwunika kwachipatala mu CS.