閱�(y墨)鐧傚櫒姊板垎椤炲強鐩�(ji膩n)绠℃(bi膩o)婧�(zh菙n)姣旇純
鐧�(f膩)甯冩檪(sh铆)闁擄細2025-03-19
閱�(y墨)鐧傚櫒姊扮殑鍒嗛閫�?锛涱媱璋勬还L(f膿ng)闅�(xi菐n)绛夌礆(j铆)銆佷娇鐢ㄧ洰鐨勫拰鐩�(ji膩n)绠¤姹�銆備互涓嬫槸涓湅(gu贸)銆佺編鍦�(gu贸)鍜屾瓙鐩熺殑涓昏鍒嗛鏂瑰紡锛�
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涓湅(gu贸)鍦�(gu贸)瀹惰棩鍝佺洠(ji膩n)鐫ｇ鐞嗗眬锛�NMPA锛夊皣閱�(y墨)鐧傚櫒姊板垎鐐轰笁椤烇細
1. 绗竴椤烇細浣庨ⅷ(f膿ng)闅�(xi菐n)锛屽澶栫鍣ㄦ銆佺梾搴婄瓑銆�
2. 绗簩椤烇細涓ⅷ(f膿ng)闅�(xi菐n)锛屽琛�澹撹▓(j矛)銆侀珨婧▓(j矛)绛夈��
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缇庡湅(gu贸)椋熷搧钘ュ搧鐩�(ji膩n)鐫ｇ鐞嗗眬锛�FDA锛夊皣閱�(y墨)鐧傚櫒姊板垎鐐轰笁椤烇細
1. Class I锛氫綆棰�(f膿ng)闅�(xi菐n)锛屽閱�(y墨)鐢ㄦ墜濂�銆佺箖甯剁瓑锛岄�氬父鍙渶涓�鑸帶鍒�銆�
2. Class II锛氫腑棰�(f膿ng)闅�(xi菐n)锛屽杓告恫娉点��X鍏夋(j墨)绛�锛岄渶鐗规畩鎺у埗銆�
3. Class III锛氶珮棰�(f膿ng)闅�(xi菐n)锛屽蹇冭嚐鐡ｈ啘銆佹鍏ュ紡闄ら～鍣ㄧ瓑锛岄渶鍤�(y谩n)鏍煎鎵广��
姝愮洘锛�CE锛�
姝愮洘鏍规摎(j霉)閱�(y墨)鐧傚櫒姊版硶瑕�(gu墨)锛�MDR锛夊垎鐐哄洓椤烇細
1. Class I锛氫綆棰�(f膿ng)闅�(xi菐n)锛屽闈炵劇(w煤)鑿屽櫒姊�銆侀潪娓�(c猫)閲忓櫒姊扮瓑銆�
2. Class IIa锛氫腑浣庨ⅷ(f膿ng)闅�(xi菐n)锛屽鍔╄伣(t墨ng)鍣�銆佽几娑插櫒绛�銆�
3. Class IIb锛氫腑楂橀ⅷ(f膿ng)闅�(xi菐n)锛屽鍛煎惛姗�(j墨)銆侀�忔瀽瑷�(sh猫)鍌欑瓑銆�
4. Class III锛氶珮棰�(f膿ng)闅�(xi菐n)锛屽蹇冭绠℃敮鏋�銆佷汉宸ュ績鑷熺瓑銆�
鍒嗛渚濇摎(j霉)
鍒嗛閫氬父鍩轰簬浠ヤ笅鍥犵礌锛�
- 浣跨敤鏅�(sh铆)闁擄細鐭湡銆侀暦(zh菐ng)鏈熸垨姘镐箙銆�
- 渚靛叆鎬э細闈炰镜鍏ャ�佷镜鍏ユ垨妞嶅叆銆�
- 浣跨敤閮ㄤ綅锛氶珨琛�銆侀珨鑵旀垨琛�娑插惊鐠�(hu谩n)銆�
- 鑳介噺渚涙噳(y墨ng)锛氭槸鍚︿緷璩村閮ㄨ兘婧愩��
绺界祼(ji茅)
- 涓湅(gu贸)锛氫笁椤烇紙I銆�II銆�III锛�
- 缇庡湅(gu贸)锛氫笁椤烇紙Class I銆�II銆�III锛�
- 姝愮洘锛氬洓椤烇紙Class I銆�IIa銆�IIb銆�III锛�
涓嶅悓鍦板崁(q奴)鐨勫垎椤炴(bi膩o)婧�(zh菙n)鐩镐技锛屼絾鍏烽珨瑕佹眰鍜岀洠(ji膩n)绠℃祦绋嬫湁鎵�涓嶅悓銆�