{"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":"etiopijas-ratinkreslu-regulejuma-rokasgramata-2025","status":"publish","type":"post","link":"https:\/\/kelingmed.com\/lv\/etiopijas-ratinkreslu-regulejuma-rokasgramata-2025\/","title":{"rendered":"Etiopija Inval\u012bdu rati\u0146kr\u0113slu atbilst\u012bba 2025. gadam: FDA 510(k) ekvivalenti un kl\u012bnisko testu atbr\u012bvojumi"},"content":{"rendered":"

1. Medic\u012bnisko ier\u012b\u010du klasifik\u0101cijas atjaunin\u0101jumi<\/strong><\/h2>\n

A. EAFDA klasifik\u0101cijas sist\u0113ma<\/strong><\/p>\n

\n\n\n\n\n\n\n\n\n
Ier\u012bces tips<\/th>\n2023. klase<\/th>\n2025. klase<\/th>\nIetekme<\/th>\n<\/tr>\n<\/thead>\n
Manu\u0101lie rati\u0146kr\u0113sli<\/td>\nI<\/td>\nII<\/td>\n94% nepiecie\u0161ama piln\u012bga tehnisk\u0101 dokument\u0101cija<\/td>\n<\/tr>\n
Elektriskie rati\u0146kr\u0113sli<\/td>\nII<\/td>\nII<\/td>\nUztur\u0113ts ar uzlabotu programmat\u016bras valid\u0101ciju<\/td>\n<\/tr>\n
Pediatrijas mode\u013ci<\/td>\nI<\/td>\nII<\/td>\nNepiecie\u0161amas jaunas biomeh\u0101nisk\u0101s p\u0101rbaudes<\/td>\n<\/tr>\n
Sporta rati\u0146kr\u0113sli<\/td>\nI<\/td>\nII<\/td>\nPapildu stabilit\u0101tes sertifik\u0101ti<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n

B. Jurisdikciju savstarp\u0113j\u0101 l\u012bdzv\u0113rt\u012bba<\/strong><\/p>\n

Atz\u012btie standarti: \u00a0
- FDA 510(k): 72% mobilit\u0101tes ier\u012b\u010du pie\u0146em\u0161anas l\u012bmenis \u00a0
- ES MDR: 58% dokument\u0101cijas savstarp\u012bgums \u00a0
- \u0136\u012bna NMPA: 39% piel\u012bdzin\u0101\u0161ana (da\u013c\u0113ja piekri\u0161ana) \u00a0<\/pre>\n
\n
2. Kl\u012bnisko pier\u0101d\u012bjumu pras\u012bbas<\/strong><\/h2>\n
A. Atbr\u012bvojuma atbilst\u012bbas krit\u0113riji<\/strong><\/p>\n
\n\n\n\n\n\n\n\n
St\u0101voklis<\/th>\nAtbr\u012bvojuma veids<\/th>\nNepiecie\u0161am\u0101 dokument\u0101cija<\/th>\n<\/tr>\n<\/thead>\n
ISO 13485 sertifik\u0101cija<\/td>\nPilns kl\u012bniskais atbr\u012bvojums<\/td>\nQMS sertifik\u0101ts + audita zi\u0146ojumi<\/td>\n<\/tr>\n
ES MDR atbilst\u012bba<\/td>\n60% testa samazin\u0101jums<\/td>\nCE tehnisk\u0101 datne + PMS dati<\/td>\n<\/tr>\n
FDA apstiprin\u0101ts predik\u0101ts<\/td>\n45% datu atk\u0101rtota izmanto\u0161ana<\/td>\n510(k) kopsavilkums + ekvivalences pier\u0101d\u012bjums<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
B. Nepiecie\u0161am\u0101 test\u0113\u0161anas matrica<\/strong><\/p>\n
\n\n\n\n\n\n\n\n
Testa veids<\/th>\nRokasgr\u0101mata<\/th>\nElektriskais<\/th>\nPediatrijas<\/th>\n<\/tr>\n<\/thead>\n
Iztur\u012bba (EN ISO 7176-8)<\/td>\n15 000 ciklu<\/td>\n20 000 ciklu<\/td>\n10 000 ciklu<\/td>\n<\/tr>\n
Dro\u0161\u012bba (IEC 60601-1)<\/td>\nNAV PIEM\u0112ROJAMS<\/td>\nOblig\u0101ti<\/td>\nNosac\u012bjuma<\/td>\n<\/tr>\n
Biomeh\u0101niskais (ISO 16840)<\/td>\nP\u0113c izv\u0113les<\/td>\nNepiecie\u0161ams<\/td>\nOblig\u0101ti<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
\n
3. Sertifik\u0101cijas process<\/strong><\/h2>\n
A. 14 posmu apstiprin\u0101\u0161anas darbpl\u016bsma<\/strong><\/p>\n
    \n
  1. \n
    Ier\u012bces klasifik\u0101cijas apstiprin\u0101jums (5-7 darba dienas) <\/p>\n<\/li>\n
  2. \n
    At\u0161\u0137ir\u012bbu anal\u012bze attiec\u012bb\u0101 pret EAFDA standartiem (14 dienas) <\/p>\n<\/li>\n
  3. \n
    Kl\u012bnisk\u0101 atbr\u012bvojuma pieteikums (ja piem\u0113rojams, 21 diena) <\/p>\n<\/li>\n
  4. \n
    Tehnisk\u0101s dokument\u0101cijas sagatavo\u0161ana (vid\u0113ji 45 dienas) <\/p>\n<\/li>\n
  5. \n
    Paraugu test\u0113\u0161ana akredit\u0113t\u0101s laboratorij\u0101s (28-35 dienas). <\/p>\n<\/li>\n
  6. \n
    Riska p\u0101rvald\u012bbas dokument\u0101cijas iesnieg\u0161ana (EN ISO 14971) <\/p>\n<\/li>\n
  7. \n
    Kvalit\u0101tes sist\u0113mas audits (ISO 13485 saska\u0146o\u0161ana) <\/p>\n<\/li>\n
  8. \n
    Pieteikumu iesnieg\u0161ana elektroniski <\/p>\n<\/li>\n
  9. \n
    S\u0101kotn\u0113j\u0101 p\u0101rskat\u012b\u0161ana (15 dienas) <\/p>\n<\/li>\n
  10. \n
    Ekspertu grupas nov\u0113rt\u0113jums (22 dienas) <\/p>\n<\/li>\n
  11. \n
    Objekta p\u0101rbaude (p\u0113c izv\u0113les, 7 dienas) <\/p>\n<\/li>\n
  12. \n
    Atbilst\u012bbas nodevas maks\u0101jums ($2,800-$4,200) <\/p>\n<\/li>\n
  13. \n
    Sertifik\u0101ta izsnieg\u0161ana (5 dienas) <\/p>\n<\/li>\n
  14. \n
    Uzraudz\u012bbas pl\u0101na aktiviz\u0113\u0161ana p\u0113c lai\u0161anas tirg\u016b <\/p>\n<\/li>\n<\/ol>\n
    B. Apstiprin\u0101\u0161anas termi\u0146i<\/strong><\/p>\n
    \n\n\n\n\n\n\n\n
    Ce\u013c\u0161<\/th>\nManu\u0101lie rati\u0146kr\u0113sli<\/th>\nElektriskie mode\u013ci<\/th>\n<\/tr>\n<\/thead>\n
    Standarta<\/td>\n154 dienas<\/td>\n178 dienas<\/td>\n<\/tr>\n
    Priorit\u0101te*<\/td>\n92 dienas<\/td>\n115 dienas<\/td>\n<\/tr>\n
    *Pieejams pas\u016bt\u012bjumiem, kas p\u0101rsniedz 500 vien\u012bbas<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
    \n
    4. Mar\u0137\u0113\u0161ana un dokument\u0101cija<\/strong><\/h2>\n
    A. Oblig\u0101tie eti\u0137etes elementi<\/strong><\/p>\n
    1. EAFDA re\u0123istr\u0101cijas numurs (vismaz 3 mm augstum\u0101) \u00a0
    2. Dro\u0161\u012bbas br\u012bdin\u0101jumi amh\u0101ru valod\u0101 (62% vietas sadal\u012bjums) \u00a0
    3. QR kods ar saiti uz elektroniskaj\u0101m instrukcij\u0101m \u00a0
    4. Importa izplat\u012bt\u0101ja kontaktinform\u0101cija \u00a0
    5. Garantijas termi\u0146i Etiopijas kalend\u0101ra datumos \u00a0<\/pre>\n
    B. Pras\u012bbas tehniskajai lietai<\/strong><\/p>\n