Takaddun shaida na CE na na'urar likita -MDR
Tarayyar Turai ta aiwatar da sabuwar dokar na'urorin likitanci ta MDR (EU 2017/745) a ranar 26 ga Mayu 2021.
A bisa sabbin ƙa'idojin na'urorin likitanci na EU "Dokar Na'urorin Lafiya" (2017/745, MDR) da "Dokar Na'urar Bincike ta Vitro" (2017/746, IVDR), Tarayyar Turai ta raba na'urorin likitanci zuwa rukuni biyu: na'urar likitanci MD da na'urar bincike ta in vitro IVD. Za a aiwatar da ƙa'idodin MDR a ranar 26 ga Mayu, 2021, kuma za a aiwatar da ƙa'idodin IVDR a ranar 26 ga Mayu, 2022.
An raba MD na na'urorin likitanci masu kutse zuwa rukuni na I, IIa, IIb, da III bisa ga matakin haɗari. An raba Ivds na na'urorin bincike marasa kutse a cikin vitro zuwa rukuni huɗu: A, B, C, da D bisa ga matakin haɗari daga ƙasa zuwa sama.
Sabbin ƙa'idojin MDR na EU za su kawo matsaloli kamar ƙarin farashi, tsawon lokacin da za a ɗauka wajen ba da takardar shaida da kuma ƙarin haɗarin bin ƙa'ida ga masu fitar da kayayyaki na China. Ana ba da shawarar cewa kamfanoni masu dacewa su yi shirye-shiryen da suka dace.
Da farko, ƙara wa sabbin ƙa'idojin MDR hankali kuma a yi aiki mai kyau wajen sabunta takardar shaidar CE. Takaddun shaida na CE da aka bayar kafin lokacin sauyawa suna aiki ba fiye da shekaru 5 ba kuma suna ƙarewa a ranar 27 ga Mayu, 2024. Dole ne a aiwatar da aikace-aikacen takaddun shaida na CE bayan 26 ga Mayu, 2021 bisa ga ƙa'idodin MDR kuma NB mai izini ya bayar;
Na biyu, a kafa wayar da kan jama'a game da inganci da kuma wayar da kan jama'a game da alhakin da ke kansu, a bi ka'idojin MDR, da kuma tabbatar da cewa kayayyaki da ka'idoji sun dace; Na uku, a karfafa sadarwa da abokan ciniki na ƙasashen waje, a fayyace ƙa'idodin samarwa da kuma buƙatun takaddun shaida don guje wa takaddama kan takaddun shaida da farashi daga baya.
Rarraba takardar shaidar MDR:
1. Aji na 1 wani kuma
2. Aji na 1 ba shi da tsafta
3. Aikin aunawa na aji na I
4. Aji na IIa
5. Aji na IIb
6. Aji na III da Aji na III tare da magani
Tsarin takardar shaidar MDR:
1. Karɓi fom ɗin neman aiki
2. Sanya hannu kan kwangila
3. Tsarin binciken masana'anta
4. Aiwatar da binciken masana'anta
5. Bayar da takardar shaidar/sake duba/jira abubuwan da ba su dace da NC ba
Fayil ɗin fasaha na takardar shaidar MDR ya ƙunshi abubuwa masu zuwa:
1. Bayani game da masana'anta (Suna da adireshin masana'anta, wurin da adireshin masana'anta da ƙira)
2. Bayyana daidaito
3. Wakilin Turai
4. Bayani game da samfurin
5. Bayanin samfur, idan ya dace, bayyanannen ma'anar samfuran da kayan haɗinsa
6. Amfani da samfurin da aka yi niyya
7. Lakabin samfur
8. Rarraba samfurin
9. Jerin ƙa'idodi da aka yi amfani da su
10. Bukatu mai mahimmanci
11. Binciken Hadari
12. Tsawon lokacin samfurin
13. Bayanan fasaha na samfurin
14. Jerin abubuwan da aka haɗa, takamaiman kayan da aka yi amfani da su, gami da takaddun shaida na daidaito, takaddun bayanai, rahotannin gwaji, bayanai game da masu samar da kayayyaki masu mahimmanci.
15. Zane na fasaha
16. Bayanin ƙera samfura, tsari na musamman, jadawalin kwarara, bayanan da aka yi amfani da su da sauransu.
17. Bayanan tabbatar da tsaftace jiki, ƙayyadaddun bayanai game da marufi
18. Bayanan daidaiton Biocompatibility
119. Rahotannin gwajin samfura
20. Tabbatar da manhaja
21. Bayanan asibiti
Likitancin Quanding ta gabatar da kayan aikin duba masana'antu da duba SGS tun farkon shekarar 2022, kuma dukkan kayayyakin kiwon lafiya na Aji II za su shiga sabuwar gwajin takardar shaidar MDR. A watan Satumba na wannan shekarar, SGS ta gudanar da gwaje-gwajen gwaji na ɗan adam akan faranti marasa inganci da za a iya zubarwa don amfani da su a fannin likitanci, kuma gwaje-gwajen sun ci nasara. Bayan za a bayar da takardar shaidar likita ta Aji II ta kasar Sin a karshen wannan shekarar, ana sa ran takardar shaidar MDR ta Tsuen Ding Medical za ta ci dukkan gwaje-gwajen da gwaje-gwajen gwaji a tsakiyar shekarar 23, kuma ta sami takardar shaidar. Sabuwar tsarin takardar shaidar da aka amince da ita tana ɗaukar lokaci mai tsawo, tsada kuma tana cinye kuzari. Quanding Medical za ta cika burinta kuma ta yi ƙoƙari don samar da kayayyakin kiwon lafiya mafi aminci da aminci kuma ta yi wa abokan cinikinmu hidima yadda ya kamata.
Lokacin Saƙo: Oktoba-27-2022
