Nekuwedzera kuri kusimbaradzwa kwemutemo wepasi rose wemidziyo yekurapa, makambani ekunze anopinda mumisika yeEurope neAmerica haafanire kusangana kwete chete nezvinodiwa zvekubvumidzwa kwekutanga kwemusika, asiwo kubata nekuomesera kweFlying Inspection (No Notice Inspection) uye Post-Market Surveillance (PMS). Pane misiyano yakakura mukutonga logic, nzira dzekuongorora uye zvirango pakati peUS FDA neEU MDR/IVDR.
Chii chinonzi FDA (US Food and Drug Administration) ?
Iyo FDA inoronga kuchengetedza uye kushanda kwemidziyo yekurapa muUnited States. Pamichina mizhinji, vagadziri vanofanirwa kuendesa 510 (k) kuratidza kuti chigadzirwa chavo chakachengeteka, chinoshanda, uye chakaenzana nechinhu chiripo chakabvumidzwa.
Chii chinonzi MDR (Medical Device Regulation) ?
MDR mutemo weEuropean Union wemidziyo yekurapa, kutsiva yaimbova MDD (Medical Device Directive). Iine zvakaomesesa zvinodiwa pakuongororwa kwekiriniki, kutariswa kwemashure kwemusika, uye zvinyorwa zvehunyanzvi kuti ive nechokwadi chekuchengetedzwa kwevarwere uye pachena.
Kufamba zvese zviri zviviri FDA neMDR kwakaoma-asi kwakaoma. PaJoytech, takavaka hurongwa hwakasimba hwekutevedzera pasi rose kubatsira vatinodyidzana navo mubhizinesi kuzadzisa izvi zvinodiwa neruvimbo. Kunyangwe iwe uri kukura kuenda kuUS kana kupinda muEU pasi peMDR, zvigadzirwa zvedu zvakasimbiswa, zvinyorwa zvehunyanzvi, uye hunyanzvi hwekutonga zviri pano kukutsigira.
Zvatichaita ?
PaJoytech, takagadzira hwaro hwakasimba hwekutonga kuti tipe simba vatinoshanda navo pasi rese. Joytech yakagadzira yakazara uye inotarisisa kuteedzera dhizaini inosangana nezvinodiwa zvepasirese zvinodiwa pamisika mikuru yezvokurapa.
FDA 510(k) Clearance
Joytech yagara yakasimbisa huvepo hwakasimba mumusika weUS, iine ese emisimboti wechigadzirwa mitsara yatove FDA yakacheneswa uye nekushingairira kupihwa kune vepasi rose. Kuvaka pahwaro uhwu hwakasimbiswa, tinoramba tichidyara mari mukuvandudza chigadzirwa uye kuvandudzwa kwemitemo kuti tisangane nezviri kubuda zvinodikanwa zvekiriniki uye zvinodiwa nepurojekiti inodiwa.
Muna 2025, isu takawedzera yedu FDA portfolio nezviti wandei zvitsva zvitupa:
Tubeless yekumusoro ruoko yeropa BP monitors - inopa inosimudzira kutakura uye ruzivo rwemushandisi.
Huru-ruoko dhijitari BP monitors (DBP-6186 / 6286B) - yakagadzirirwa saizi yemaoko akawedzerwa (40-56 cm), ine maBluetooth sarudzo.
Compressor nebulizers (NB-1100 kusvika NB-1103) - FDA-yakacheneswa pasi peChigadzirwa Code CAF, inotsigira kurapa kwakavimbika kwekufema kumba kana mumakiriniki.
EU MDR Certification
Joytech iri pakati pevagadziri vekutanga veChinese kuwana EU MDR certification pasi pemutemo mutsva. Muna Kubvumbi 2022 , takagamuchira chitupa chedu chekutanga cheMDR kubva kuTÜV SÜD, chinovhara zvigadzirwa zvakaita sedhijitari thermometers, infrared thermometers (nzeve & pahuma), pombi yemazamu, uye asingapindire eropa mamonitor-kumaka kubvumidzwa kweMDR kwekutanga kuChina kune akati wandei zvinosanganisira mathermometer emagetsi nemapombi emazamu.
Kubva ipapo, takaenderera mberi nekuwedzera yedu MDR-yakasimbiswa portfolio gore negore. Pakazosvika Gumiguru 2023 , ese echizvarwa chitsva cheBP uye mathermometers akanga agamuchira CE (MDR) mvumo. Kubva muna Kukadzi 2025 , batch yedu yechina yezvigadzirwa zvakasimbiswa inosanganisira:
Uku kuwedzera kuri kuenderera mberi kunoratidza kuzvipira kwakadzama kwaJoytech mukutevedzera, kugadzirwa kwechigadzirwa, uye kugona kwekutonga. Hupenyu hwedu huzere hwechigadzirwa - dhizaini, kuyedza, kugadzira, zvinyorwa, uye mushure memusika kuongororwa - inosangana neyakaomesesa zviyero zveEurope, kupa simba vatinoshanda navo neyakasimbiswa, yakagadzirira-kumusika mhinduro muEU yose.
Mimwe Mitemo Yemitemo
Maitiro edu ekugadzira anosimbiswa pasi peISO 13485 uye MDSAP , achizadzisa zvinodiwa zveUS, Canada, Australia, Japan, neBrazil.
Zvakare, zvigadzirwa zveJoytech zvinoenderanawo neNMPA (China), RoHS, uye REACH mirairo, kuchengetedzwa kwemisangano, kwezvakatipoteredza, uye zvinyorwa zvinyorwa muAsia neEU.
Zvazvinoreva kune Vatinoshanda navo？
Kushanda neJoytech kunoreva zvinopfuura kungotsvaga chigadzirwa-zvinoreva kuwana mudiwa wehutano anonzwisisa kuoma kwekuteerera kwenyika.
v Njodzi dzekudzora dzakaderera uye mitengo - Yedu yakagadzirira-kuenda-kuenda zvitupa uye ruzivo nekuongorora kwepasirese kunoderedza mutoro pane yako yenzvimbo yekunyoresa maitiro.
v Kukurumidza kuwana musika - Nezvishandiso zvakafanosimbiswa, unogona kuvhura munzvimbo dzako dzaunotariswa nekukurumidza uye kunonoka kudiki.
v Yakagadziridzwa tekinoroji uye rutsigiro rwekiriniki - Kubva kumagwaro ehunyanzvi kusvika kudhata rekiriniki, timu yedu yemukati-yekutonga inopa rutsigiro rwakarongedzerwa kusangana nenyika yako-zvaunoda.
v Hunhu hwakapupurirwa uye kugadzirira kwekuongorora - Yedu yemhando sisitimu yakapfuura akawanda echitatu-bato maodhisheni, uye zvinyorwa zvedu zvinogara zvakachengetwa zvakagadziriswa-zvakagadzirirwa, kuve nechokwadi chekujeka uye kushanda nesimba.
Mhedziso:
Sezvo mitemo inoshanduka, isu tichadarowo. Joytech yakazvipira kuramba ichiwedzera nzira yayo yepasirese yekutevedza nezvitupa zvakaita seFDA neMDR - kuve nechokwadi chekuti vatinoshanda navo vawana mukana usingakanganisike kune zvakasimbiswa, zvemhando yepamusoro michina yekurapa mumisika ine hurongwa.
Isu takatobata zvitupa munzvimbo dzakakura dzepasirese, kusanganisira North America, EU, Asia, uye mhiri.
Unoda kuziva kana isu takapihwa zvitupa pamusika wako?
Kutsvaga mhinduro-yakagadzirira OEM / ODM mhinduro?
Bata nechikwata chedu nhasi kuti uongorore ruzivo rwechigadzirwa certification, zvinyorwa zvehunyanzvi, uye mhinduro dzakagadzirirwa purojekiti yako. NaJoytech, kutevedzera kunova mukana wako wemakwikwi.
