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Hitec MedicalFDAmaphunziro - FDA'sDtanthauzo laMedicalDezoipa

FDA ndiDtanthauzo laMedicalDezoipa

Zipangizo zachipatala zimanena za zida, zida, makina, zida, machubu oyika, zopangira zinthu m'thupi, kapena zinthu zina zogwirizana ndi izi, kuphatikiza zigawo, zigawo, kapena zowonjezera: zomwe zalembedwa mchitoliro chovomerezeka cha National Formulary national kapena United States Pharmacopeia kapena zomata ku ziwiri zomwe tatchulazi;Amagwiritsidwa ntchito pozindikira matenda a nyama kapena anthu kapena matenda ena amthupi;Kapena amagwiritsidwa ntchito pochiza, kuchepetsa, kapena kuchiza matenda;Amafuna kukhudza magwiridwe antchito kapena kapangidwe ka nyama kapena thupi la munthu, koma osadalira momwe amachitira nyama kapena thupi la munthu kapena thupi kuti akwaniritse cholinga chake chachikulu, komanso osadalira kagayidwe kuti akwaniritse cholinga chake choyambirira.

Gulu la FDA la zida zamankhwala

Class I General Control

Class II general control + special control

Chidziwitso cha Premarket (PMN), 510 (K)

Class III General Control + Pre Msika Kuvomerezeka

Chilolezo Chogulitsira Patsogolo (PMA)

Mfundo yake ndi kugawa zinthu malinga ndi kuchuluka kwa chiwopsezo chawo.

FDA pakadali pano ili ndi zida zopitilira 1700, zogawidwa m'malo 16 apadera ogwiritsira ntchito.