Nekuwedzera kuri kuita kusimba kwemutemo wepasi rose wemidziyo yezvokurapa, 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 zvinodikanwa zvekuongororwa kwekiriniki, kutariswa kwemashure kwemusika, uye zvinyorwa zvehunyanzvi kuti ive nechokwadi chekuchengetedzwa kwevarwere uye pachena.
Kufamba zvese zviri zviviri FDA uye MDR kwakaoma-asi kwakaoma. PaJoytech, takavaka hurongwa hwakasimba hwekuteerera pasi rose kubatsira vatinodyidzana navo mubhizinesi kuzadzisa zviyero izvi zvinoda nechivimbo. 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 hwekupa simba vatinoshanda navo pasi rese. Joytech yakavaka hurongwa hwakakwana uye hwekutarisira-kumberi hunoenderana nezvinodiwa pasi rose pamisika mikuru yezvokurapa.
FDA 510(k) Clearance
Joytech yagara yakasimbisa huvepo hwakasimba mumusika weUS, iine ese emisimboti zvigadzirwa mitsara yatove FDA yakacheneswa uye nekushingairira kupihwa kune vepasi rose. Kuvaka pahwaro huno hwakasimbiswa, isu 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 hukuru hwemaoko akareba (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 muChina kune akati wandei zvinosanganisira mathermometer emagetsi nemapombi emazamu.
Kubva ipapo, takaenderera mberi nekuwedzera yedu MDR-yakasimbiswa portfolio gore negore. Pakazosvika Gumiguru 2023 , ese mazera matsva ekudzivirira kweropa uye mathermometers akanga agamuchira CE (MDR) mvumo. Kubva muna Kukadzi 2025 , batch yedu yechina yezvigadzirwa zvakasimbiswa inosanganisira:
Uku kuwedzera kuri kuitika kunoratidza kuzvipira kwakadzama kwaJoytech mukutevedzera, kugadzirwa kwechigadzirwa, uye kugona kwekutonga. Hupenyu hwedu hwakazara hwechigadzirwa - dhizaini, kuyedza, kugadzira, zvinyorwa, uye mushure memusika kuongorora - inosangana neyakaomesesa zviyero zveEurope, kupa simba vatinoshanda navo neyakasimbiswa, yakagadzirira-kumusika mhinduro muEU.
Mimwe Mitemo Yemitemo
Maitiro edu ekugadzira anosimbiswa pasi pe ISO 13485 uye MDSAP , achizadzisa zvinodiwa zveUS, Canada, Australia, Japan, neBrazil.
Zvakare, zvigadzirwa zveJoytech zvinoenderanawo neNMPA (China), RoHS, uye REACH mirairo, kuchengetedzwa kwemusangano, zvakatipoteredza, uye zvinyorwa zvinyorwa muAsia yose neEU.
Zvazvinoreva kune Vatinoshanda navo？
Kushanda neJoytech kunoreva zvinopfuura kungotsvaga chigadzirwa-zvinoreva kuwana mudiwa ane hunyanzvi anonzwisisa kuomarara 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 Kurumidza kuwana musika - Nezvishandiso zvakafanosimbiswa, unogona kuvhura munzvimbo dzako dzaunotariswa nekukurumidza uye kunonoka kudiki.
v Yakagadziridzwa tekinoroji uye rutsigiro rwekiriniki - Kubva kumagwaro ehunyanzvi kuenda kudhata rekiriniki, timu yedu yemukati-yekutonga inopa rutsigiro rwakarongedzerwa kusangana nenyika yako-zvaunoda.
v Hunhu hwakaratidzwa uye kugadzirira kwekuongorora - Yedu yemhando sisitimu yakapfuura akawanda echitatu-bato maodhisheni, uye zvinyorwa zvedu zvinogara zvakachengetwa zvakagadzirirwa-zvakagadzirirwa, kuve nechokwadi chekujeka uye kushanda nesimba.
Mhedziso:
Sezvo mitemo inoshanduka, isu tichadarowo. Joytech yakazvipira kuenderera mberi nekuwedzera mugwagwa wayo wepasirese wekutevedza 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.
