Sezvo kudiwa kwepasirese kwemhando yepamusoro-soro yemidziyo yekurapa inoraswa kuri kuramba kuchikura, masangano anodzora muEurope neUnited States ari kusimbisa zvinodikanwa zvekuteedzera-kunyanya majekiseni uye zvinhu zvekuunganidza ropa. Aya maturusi akakosha ekurapa ari pasi pekutariswa zvakanyanya nekuda kwekushandiswa kwakawanda mukuongorora, majekiseni, uye kutarisirwa kwevarwere.
Kune vagadziri, vanounza kunze kwenyika, uye vanogovanisa, kunzwisisa iyi miitiro iri kusimukira hakusi kwekungoita zvinodiwa nemutemo — chinhu chakakosha pakuona kuchengetedzwa kwechigadzirwa, kuvandudza kuwanikwa kwemusika, uye kuvaka kuvimbika kwenguva refu.
Yakasimba Yakatarisana Nekuchengetedza uye Kuteedzera
MuEuropean Union neUnited States, kuchengetedzeka kwemurwere ndiko kunotungamira kuseri kwekuchinja kutsva kwemitemo. Semuenzaniso, EU's Medical Device Regulation (MDR), iyo yakatsiva zvizere MDD yapfuura muna 2021, inosimbisa kuongororwa kwekiriniki kwakadzama, kuongororwa kwenjodzi, uye kuongororwa mushure memusika.
MuUS, iyo FDA's 21 CFR Chikamu 820 (Quality System Regulation) inoramba ichishanda sehwaro hwekugadzira zviyero. Nekudaro, zvigadziriso zviri kuuya zvakaenderana neISO 13485 zvichaisa yakanyanyisa kutarisa pakuteedzera uye zvinyorwa-kunyanya zveKirasi II zvishandiso senge sirinji nemachubhu ekuunganidza ropa.
Izvi zvinorevei kune vatengesi? Yese nhanho yeketani yekugovera — kubva pakusarudzwa kwezvinhu kusvika pakurongedzerwa — inofanira ikozvino kurondwa uye kutariswa.
Kusimbisa paBiocompatibility uye Sterility Assurance
Nekunetseka kuri kuwedzera pamusoro pemaitiro evarwere uye njodzi yekusvibiswa, biocompatibility bvunzo haichave sarudzo. European neUS regulator inoda kuyedzwa kwakadzama pasi peISO 10993 zviyero kuratidza kuti zvinhu zvinoshandiswa mumajekiseni, lancets, uye machubhu zvakachengeteka pakubata kwevanhu.
Pamusoro pezvo, maitiro ekuita sterilization (senge ethylene oxide kana gamma irradiation) anofanirwa kuzadzisa zvinodiwa zvekusimbisa zvakataurwa mu ISO 11135 kana ISO 11137, zvichiteerana. Kuvimbiswa sterility kunonyanya kukosha kune zvigadzirwa zvakafanozadzwa kana kushandiswa mukuunganidza ropa zvakananga.
Kune vatengi vezvokurapa nevanotenga kunze kwenyika, izvi zvinoreva kusarudza vatengesi vanogona kupa zvakanyorwa zvinyorwa zve sterility uye maitiro akasimbiswa kwakakosha kupfuura kare.
Eco-Conscious Zvishandiso uye Sustainable Packaging Zvinodiwa
Mumakore achangopfuura, kusimba kwakatama kubva pakushambadzira meseji kuenda kune tarisiro yekutonga. EU iri kushingaira kukurudzira kudzikiswa kwemapurasitiki anoshandiswa kamwe chete uye zvinhu zvinokuvadza zvakatipoteredza. Kunyangwe zvigadzirwa zvekurapa kazhinji zvisingarambidzwe, kune kudzvanywa kuri kukura kwekushandisa zvinogoneka kana bio-based zvinhu pese pazvinogoneka.
Saizvozvo, musika weUS - kunyanya pakati pematanho makuru ekutenga hutano - uri kuwedzera kuongorora zvigadzirwa zvichibva pane yavo yezvakatipoteredza tsoka. Packaging inoderedza tsvina, kana zvishandiso zvakagadzirwa kubva kuBPA-isina uye DEHP-yemahara zvinhu, zviri kuita zvakajairika zvinodiwa.
Kune vagadziri vezvekushandisa zvekuunganidza ropa uye majekiseni, kuchinjika kune izvi zvinotarisirwa hakungozadzise kuteedzera-asi zvakare kunowedzera kukwikwidza.
Iko Kukosha Kwekunyora Kwazvo uye UDI Kutevedzera
Masangano anodzora ari kukanganisa kurongeka kwemazita. EU MDR neUS FDA zvese zvinoda kuti zvigadzirwa zvinge zvakadhindwa zvakajeka Unique Device Identifiers (UDI), mazuva ekupera kwenguva, nhamba dzebatch, uye mitauro yemuno pamisika yavanotengeswa.
Kutadza kuzadzisa zviyero izvi zvinogona kukonzera kunonoka kutsika, kuyeuka, kana kurasikirwa kwemusika. Kusarudza yekurongedza uye yekuisa manyorero inotsigira zvinodikanwa zvekunyora mazita inhanho yakakosha mukuona kutsetseka kwekupinda / kutumira kunze mashandiro.
Kufambisa Mitemo neKuvimba
Kufamba nemamiriro ezvinhu akaomarara ekutonga muEurope neUS kunoda zvinopfuura kungoteedzera kwekutanga-zvinoda kugadzirira kwakasimba, kuenderera mberi kwechigadzirwa kusimbiswa, uye kunyatsotarisisa kune ari kubuda maitiro.
Kune vatengi, vanotenga kunze kwenyika, uye varapi vehutano zvakafanana, kugara uine ruzivo nezve yazvino mirairo mumajekiseni uye zvinhu zvekuunganidza ropa zvakakosha pakuita sarudzo dzakangwara.
Uri kutsvaga kuona kuti zvigadzirwa zvako zvekurapa zvinoraswa zvinosangana nepasirese regulatory zviyero? Svika kuSinomed nhasi uye uongorore kuti mhinduro dzedu dzinotsigira sei kutevedzera kwako uye zvinangwa zvemhando.
Nguva yekutumira: Jun-23-2025
