Mai Ianuali 1, 2022, pono e hoʻopaʻa inoa ʻia nā mea lapaʻau hou a pau e komo ana i nā ʻāina ʻo Eurasian Economic Union e like me Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, etc. A laila e ʻae i ka noi no ka palapala hoʻopaʻa inoa lāʻau lapaʻau i hoʻokahi ʻāina. Hiki ke hoʻohana ʻia nā mea lapaʻau i hoʻopaʻa inoa ʻia ma ka Russian Federation, a i ʻole hiki ke hoʻololi ʻia ka palapala hōʻoia a hiki i 2027.
EAC MDR Hoʻohālikelike Huahana
Wahi a nā pae pilikia like ʻole, hiki ke hoʻokaʻawale ʻia ka EAC MDR i ka Papa I, Class IIa, Class IIb, Class III, nona ka Class III ka pae kiʻekiʻe loa, e like me ka European Union. ʻO ke kiʻekiʻe o ka pae pilikia, ʻoi aku ka kiʻekiʻe o nā kaʻina hana a me nā koi.
Ke Kaʻina Hana Hōʻoia EAC MDR
1. Ka ho'oholo 'ana i ka pae pilikia a me ke 'ano o ka nomenclature e ho'ohana 'ia 2. Ka ho'oholo 'ana i ka papa helu helu palapala 3. Ohi 'ana i nā hō'ike o ka palekana a me ka pono 4. Ke koho 'ana i ke kūlana kuhikuhi a me ke kūlana 'ike.
5. E uku i na dute
6. Hoʻouna i nā palapala
7. Ka nānā 'ana i nā mea lapa'au, etc.
8. Ke Kaʻina Aʻo
9. Hoʻopaʻa inoa mea lapaʻau
EAC MDR palapala hōʻoia
ʻO ka papa inoa ʻike ma lalo nei he koho, ma muli o ka pae pilikia o ka huahana e hōʻoia inā pono e hāʻawi ʻia.
1. E noi ma ke ʻano i kuhikuhi ʻia ma ka Appendix
2 a me 3 o ka "Registration and Professional Rules for the Safety, Quality and Efficiency of Medical Devices"
3. ʻO ka palapala ʻae e hōʻike ana i nā pono o ka mea hana i ke kau inoa ʻana
4. He kope o ka palapala hōʻoia ʻōnaehana hoʻokele maikaʻi o ka mea hana lāʻau lapaʻau (ISO 13485 a i ʻole nā kūlana kūloko a i ʻole ke aupuni o nā mokuʻāina lālā)
5. ʻO ka ʻōlelo hoʻohālikelike o ka palekana a me ka pono o ka lāʻau lapaʻau a i ʻole ka palapala like
6. ʻO ka palapala hoʻopaʻa inoa i hāʻawi ʻia e ka ʻāina o ka hana ʻana ( Kope o ka palapala hōʻoia o ke kūʻai kūʻokoʻa, palapala hoʻokuʻu aku (koe naʻe nā mea lapaʻau i hana mua ʻia ma ka ʻāina o ka Moku'āina Member)) a unuhi ʻia i ka ʻōlelo Lūkini
7. Kope o nā palapala e hōʻoia ana i ke kākau inoa ʻana ma nā ʻāina ʻē
8. Palapala hōʻike lāʻau lapaʻau e hōʻike ana i ka lāʻau lapaʻau Ka laulā, ka hoʻohana ʻana, nā hiʻohiʻona pōkole, nā mana a me nā lako (nā palapala)
9. Ka hōʻailona ʻana a me ka hōʻike ʻana i ka ʻikepili (ka waihoʻoluʻu piha o ka ʻeke a me nā lepili, nā kikokikona i kaha ʻia ma ka ʻōlelo Lūkini a me nā ʻōlelo kūhelu o nā mokuʻāina lālā)
10. Hoʻomohala a me ka ʻike hana: nā kiʻi kaʻina hana hana, nā ʻanuʻu hana nui, hoʻopili, hoʻāʻo a me nā kaʻina hana hoʻokuʻu huahana hope
11. ʻIke e pili ana i ka mea hana: inoa, ʻano hana, ʻōlelo kū kānāwai, ke ʻano o ke kuleana, ka hoʻonohonoho ʻana o ka hoʻokele, ka papa inoa o nā keʻena a me nā lālā, a me ka wehewehe ʻana i ko lākou kūlana a me nā mana.
12. Nā hanana a me ka hoʻomanaʻo hōʻike (ʻaʻole hāʻawi i ka ʻike e pili ana i nā mea lapaʻau hou i kūkulu ʻia a hoʻolālā ʻia): he papa inoa o nā hanana ʻino a i ʻole nā hanana e pili ana i ka hoʻohana ʻana i ka hāmeʻa, a me kahi hōʻailona o ka manawa i hana ʻia ai kēia mau hanana, inā aia. he nui loa nā hanana pōʻino, pono paha nā ʻano o nā hanana e hāʻawi i kahi ʻike pōkole a hōʻike i ka huina o nā hanana i hōʻike ʻia no kēlā me kēia ʻano He papa inoa o nā manaʻo a / a i ʻole nā wehewehe wehewehe no ka mākeke mea lapaʻau a me ka wehewehe ʻana i nā hanana, nā ala e hoʻoponopono ai iā lākou a me ka mea hana i kēlā me kēia hihia.
14. Nā koi maʻamau, nā koina lepili a me nā ʻike e koi ʻia e nā palapala hana (i ʻōlelo ʻia ma hope nei - nā koi maʻamau)
15. Nā palapala e hoʻokumu ana i nā koi no nā ʻano loea o nā mea lapaʻau.
17. Nā protocols no nā haʻawina (nā hoʻāʻo) e loiloi i nā hopena olaola o nā mea lapaʻau.
18. Hōʻike nā hōʻike hōʻike lapaʻau e pili ana i ka pono a me ka palekana o nā mea lapaʻau
19. Nā hōʻike loiloi pilikia
20. ʻIke lāʻau lapaʻau i loko o nā mea hana lāʻau lapaʻau (ka hoʻohui ʻana i ka lāʻau, ka nui, ka lāʻau lapaʻau a me ka ʻikepili pili i ka lāʻau lapaʻau, Ka hoʻopaʻa inoa ʻana o ka huahana lāʻau ma ka ʻāina i hana ʻia)
21. ʻIkepili biosafety
22. Ka ʻikepili kaʻina hana sterilization, me ka hōʻoia ʻana o ke kaʻina hana, nā hopena hōʻike microbiological (level of bioburden), pyrogenicity, sterility (inā pono), a me nā ʻōlelo aʻoaʻo a me ka hoʻopili ʻana i ka ʻike e pili ana i ka ʻikepili hōʻoia (nā huahana sterile)
23. ʻIke lako polokalamu kikoʻī (inā loaʻa): Ka ʻike a ka mea hana e pili ana i ka hōʻoia polokalamu
24. Hōʻike haʻawina kūpaʻa - me ka unuhi Lūkini ʻoiaʻiʻo o nā hopena hoʻāʻo a me nā hopena no nā huahana me ke ola paʻa.
25. Hoʻohana ma nā ʻāina i ʻike ʻia Nā palapala hana a i ʻole nā ʻōlelo aʻoaʻo no ka hoʻohana ʻana i ka lāʻau lapaʻau ma ka ʻōlelo aupuni (inā pono) a ma ka ʻōlelo Lūkini.
26. Nā manual lawelawe (i ka hihia o nā ʻāpana o nā mea lapaʻau) - i ka nele o ka ʻikepili i ka palapala hana.
27. Nā hōʻike no ka nānā ʻana i nā huahana 28. Nā hoʻolālā no ka hōʻiliʻili a me ka nānā ʻana i nā ʻikepili e pili ana i ka palekana a me ka pono o nā mea lapaʻau i ka wā post-marketing.