{"id":5416,"date":"2025-02-24T01:15:55","date_gmt":"2025-02-24T01:15:55","guid":{"rendered":"https:\/\/kelingmed.com\/?p=5416"},"modified":"2025-02-24T01:16:58","modified_gmt":"2025-02-24T01:16:58","slug":"%ec%97%90%ed%8b%b0%ec%98%a4%ed%94%bc%ec%95%84-%ed%9c%a0%ec%b2%b4%ec%96%b4-%ea%b7%9c%ec%a0%9c-%ea%b0%80%ec%9d%b4%eb%93%9c-2","status":"publish","type":"post","link":"https:\/\/kelingmed.com\/ko\/%ec%97%90%ed%8b%b0%ec%98%a4%ed%94%bc%ec%95%84-%ed%9c%a0%ec%b2%b4%ec%96%b4-%ea%b7%9c%ec%a0%9c-%ea%b0%80%ec%9d%b4%eb%93%9c-2\/","title":{"rendered":"\uc5d0\ud2f0\uc624\ud53c\uc544 \ud720\uccb4\uc5b4 \uaddc\uc815 \uc900\uc218 2025: FDA 510(k) \ub3d9\ub4f1\uc131 \ubc0f \uc784\uc0c1 \uc2dc\ud5d8 \uba74\uc81c"},"content":{"rendered":"

1. \uc758\ub8cc \uae30\uae30 \ubd84\ub958 \uc5c5\ub370\uc774\ud2b8<\/strong><\/h2>\n

A. EAFDA \ubd84\ub958 \uccb4\uacc4<\/strong><\/p>\n

\n\n\n\n\n\n\n\n\n
\ub514\ubc14\uc774\uc2a4 \uc720\ud615<\/th>\n2023 \ud074\ub798\uc2a4<\/th>\n2025 \ud074\ub798\uc2a4<\/th>\n\uc601\ud5a5<\/th>\n<\/tr>\n<\/thead>\n
\uc218\ub3d9 \ud720\uccb4\uc5b4<\/td>\nI<\/td>\nII<\/td>\n94%\ub294 \uc804\uccb4 \uae30\uc220 \ubb38\uc11c\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/td>\n<\/tr>\n
\uc804\ub3d9 \ud720\uccb4\uc5b4<\/td>\nII<\/td>\nII<\/td>\n\ud5a5\uc0c1\ub41c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc720\ud6a8\uc131 \uac80\uc0ac\ub85c \uc720\uc9c0 \uad00\ub9ac<\/td>\n<\/tr>\n
\uc18c\uc544 \ubaa8\ub378<\/td>\nI<\/td>\nII<\/td>\n\uc0c8\ub85c\uc6b4 \uc0dd\uccb4 \uc5ed\ud559 \ud14c\uc2a4\ud2b8 \ud544\uc694<\/td>\n<\/tr>\n
\uc2a4\ud3ec\uce20 \ud720\uccb4\uc5b4<\/td>\nI<\/td>\nII<\/td>\n\ucd94\uac00 \uc548\uc815\uc131 \uc778\uc99d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n

B. \uad00\ud560\uad8c \uac04 \ub3d9\ub4f1\uc131<\/strong><\/p>\n

\uc778\uc815\ub41c \ud45c\uc900: \u00a0
- FDA 510(k): \ubaa8\ube4c\ub9ac\ud2f0 \ub514\ubc14\uc774\uc2a4\uc5d0 \ub300\ud55c 72% \uc2b9\uc778\ub960 \u00a0
- EU MDR: 58% \ubb38\uc11c \uc0c1\ud638\uc131 \u00a0
- \uc911\uad6d NMPA: 39% \uc815\ub82c(\ubd80\ubd84 \uc2b9\uc778) \u00a0<\/pre>\n
\n
2. \uc784\uc0c1 \uc99d\uac70 \uc694\uac74<\/strong><\/h2>\n
A. \uba74\uc81c \uc790\uaca9 \uae30\uc900<\/strong><\/p>\n
\n\n\n\n\n\n\n\n
\uc870\uac74<\/th>\n\uba74\uc81c \uc720\ud615<\/th>\n\ud544\uc694\ud55c \uc11c\ub958<\/th>\n<\/tr>\n<\/thead>\n
ISO 13485 \uc778\uc99d<\/td>\n\uc804\uccb4 \uc784\uc0c1 \uba74\uc81c<\/td>\nQMS \uc778\uc99d\uc11c + \uac10\uc0ac \ubcf4\uace0\uc11c<\/td>\n<\/tr>\n
EU MDR \uc900\uc218<\/td>\n60% \ud14c\uc2a4\ud2b8 \uac10\uc18c<\/td>\nCE \uae30\uc220 \ud30c\uc77c + PMS \ub370\uc774\ud130<\/td>\n<\/tr>\n
FDA \uc2b9\uc778 \uc220\uc5b4<\/td>\n45% \ub370\uc774\ud130 \uc7ac\uc0ac\uc6a9<\/td>\n510(k) \uc694\uc57d + \ub3d9\ub4f1\uc131 \uc99d\uba85<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
B. \ud544\uc218 \ud14c\uc2a4\ud2b8 \ub9e4\ud2b8\ub9ad\uc2a4<\/strong><\/p>\n
\n\n\n\n\n\n\n\n
\ud14c\uc2a4\ud2b8 \uc720\ud615<\/th>\n\ub9e4\ub274\uc5bc<\/th>\n\uc804\uae30<\/th>\n\uc18c\uc544\uacfc<\/th>\n<\/tr>\n<\/thead>\n
\ub0b4\uad6c\uc131(EN ISO 7176-8)<\/td>\n15,000\uc8fc\uae30<\/td>\n20,000\uc8fc\uae30<\/td>\n10,000\uc8fc\uae30<\/td>\n<\/tr>\n
\uc548\uc804(IEC 60601-1)<\/td>\nN\/A<\/td>\n\ud544\uc218<\/td>\n\uc870\uac74\ubd80<\/td>\n<\/tr>\n
\uc0dd\uccb4 \uc5ed\ud559(ISO 16840)<\/td>\n\uc120\ud0dd \uc0ac\ud56d<\/td>\n\ud544\uc218<\/td>\n\ud544\uc218<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
\n
3. \uc778\uc99d \ud504\ub85c\uc138\uc2a4<\/strong><\/h2>\n
A. 14\ub2e8\uacc4 \uc2b9\uc778 \uc6cc\ud06c\ud50c\ub85c<\/strong><\/p>\n
    \n
  1. \n
    \uae30\uae30 \ubd84\ub958 \ud655\uc778(\uc601\uc5c5\uc77c \uae30\uc900 5~7\uc77c) <\/p>\n<\/li>\n
  2. \n
    EAFDA \uae30\uc900 \ub300\ube44 \uac2d \ubd84\uc11d(14\uc77c) <\/p>\n<\/li>\n
  3. \n
    \uc784\uc0c1 \uba74\uc81c \uc2e0\uccad(\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0, 21\uc77c) <\/p>\n<\/li>\n
  4. \n
    \uae30\uc220 \ubb38\uc11c \uc900\ube44(\ud3c9\uade0 45\uc77c) <\/p>\n<\/li>\n
  5. \n
    \uacf5\uc778 \uc5f0\uad6c\uc18c\uc758 \uc0d8\ud50c \ud14c\uc2a4\ud2b8(28~35\uc77c) <\/p>\n<\/li>\n
  6. \n
    \uc704\ud5d8 \uad00\ub9ac \ud30c\uc77c \uc81c\ucd9c(EN ISO 14971) <\/p>\n<\/li>\n
  7. \n
    \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uac10\uc0ac(ISO 13485 \uc815\ub82c) <\/p>\n<\/li>\n
  8. \n
    \uc804\uc790 \uc9c0\uc6d0\uc11c \uc81c\ucd9c <\/p>\n<\/li>\n
  9. \n
    \uc608\ube44 \uac80\ud1a0(15\uc77c) <\/p>\n<\/li>\n
  10. \n
    \uc804\ubb38\uac00 \ud328\ub110 \ud3c9\uac00(22\uc77c) <\/p>\n<\/li>\n
  11. \n
    \uc2dc\uc124 \uc810\uac80(\uc120\ud0dd \uc0ac\ud56d, 7\uc77c) <\/p>\n<\/li>\n
  12. \n
    \uaddc\uc815 \uc900\uc218 \uc218\uc218\ub8cc \uc9c0\ubd88($2,800-$4,200) <\/p>\n<\/li>\n
  13. \n
    \uc778\uc99d\uc11c \ubc1c\uae09(5\uc77c) <\/p>\n<\/li>\n
  14. \n
    \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uacc4\ud68d \ud65c\uc131\ud654 <\/p>\n<\/li>\n<\/ol>\n
    B. \uc2b9\uc778 \ud0c0\uc784\ub77c\uc778<\/strong><\/p>\n
    \n\n\n\n\n\n\n\n
    \uacbd\ub85c<\/th>\n\uc218\ub3d9 \ud720\uccb4\uc5b4<\/th>\n\uc804\uae30 \ubaa8\ub378<\/th>\n<\/tr>\n<\/thead>\n
    \ud45c\uc900<\/td>\n154\uc77c<\/td>\n178\uc77c<\/td>\n<\/tr>\n
    \uc6b0\uc120\uc21c\uc704*<\/td>\n92\uc77c<\/td>\n115\uc77c<\/td>\n<\/tr>\n
    *500\uac1c \uc774\uc0c1 \uc8fc\ubb38 \uc2dc \uc0ac\uc6a9 \uac00\ub2a5<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
    \n
    4. \ub77c\ubca8\ub9c1 \ubc0f \ubb38\uc11c\ud654<\/strong><\/h2>\n
    A. \ud544\uc218 \ub77c\ubca8 \uc694\uc18c<\/strong><\/p>\n
    1. EAFDA \ub4f1\ub85d \ubc88\ud638(\ucd5c\uc18c 3mm \ub192\uc774) \u00a0
    2. \uc554\ud558\ub77c\uc5b4 \uc548\uc804 \uacbd\uace0(62% \uacf5\uac04 \ud560\ub2f9) \u00a0
    3. \uc804\uc790 \uc9c0\uce68\uc73c\ub85c \uc5f0\uacb0\ub418\ub294 QR\ucf54\ub4dc \u00a0
    4. \ub300\ub9ac\uc810 \uc5f0\ub77d\ucc98 \uc815\ubcf4 \uac00\uc838\uc624\uae30 \u00a0
    5. \uc5d0\ud2f0\uc624\ud53c\uc544 \ub2ec\ub825 \ub0a0\uc9dc\ub85c \ud45c\uc2dc\ub41c \ubcf4\uc99d \uae30\uac04 \u00a0<\/pre>\n
    B. \uae30\uc220 \ud30c\uc77c \uc694\uad6c \uc0ac\ud56d<\/strong><\/p>\n