Wit di tayt we dɛn de tayt mɔ ɛn mɔ pan di glob ɔl mɛdikal divays rigyuleshɔn, ovasi kɔmni dɛn we de kam insay di Yuropian ɛn Amɛrikan makit dɛn nid fɔ mit nɔto jɔs di kɔmpleks prɛ-maket aprɔval rikwaymɛnt dɛn, bɔt dɛn nid fɔ dil bak wit strɛng Flay Inspekshɔn (No Notis Inspekshɔn) ɛn Pɔst-Maket Sɔvɛlayshɔn (PMS). Big difrɛns de pan rigyuletɔri lɔjik, inspekshɔn we ɛn penalty bitwin US FDA ɛn EU MDR/IVDR.
Wetin na FDA (US Food and Drug Administration) ? Di FDA de rigul di sef ɛn ɛfɛktiv we di mɛrɛsin divays dɛn de yuz na Amɛrika. Fɔ bɔku divays dɛn, di wan dɛn we de mek dɛn fɔ sɛn 510(k) fɔ pruv se dɛn prɔdak sef, i wok, ɛn i rili ikwal to divays we dɛn dɔn gri fɔ yuz.
Wetin na MDR (Mɛdikal Divays Rɛgyuleshɔn) ? MDR na di Yuropian Yuniɔn in rigyuleshɔn fɔ mɛdikal divays, we tek ples fɔ di fɔs MDD (Mɛdikal Divays Dairekt). I gɛt strikt rikwaymɛnt fɔ klinik ɛvalueshɔn, post-maket sɔvɛlayshɔn, ɛn tɛknikal dɔkyumentri fɔ mek shɔ se di pasɛnt sef ɛn transparency bɛtɛ.
Fɔ navigate ɔl tu di FDA ɛn MDR na kɔmpleks—bɔt i rili impɔtant. Na Joytech, wi dɔn bil wan strɔng glob ɔl kɔmplians sistɛm fɔ ɛp wi biznɛs patna dɛn fɔ mit dɛn dimand standad ya wit kɔnfidɛns. If yu de go na di US ɔ yu de go insay di EU ɔnda MDR, wi sɛtifiket prɔdak dɛm, tɛnki dɔkyumentri, ɛn rigyuletɔri ɛkspɛriɛns de ya fɔ sɔpɔt yu.
Wi Wetin Gɛt ?
Na Joytech, wi dɔn mek wan strɔng rigyuletɔri fawndeshɔn fɔ gi pawa to wi patna dɛn ɔlsay na di wɔl. Joytech dɔn bil wan kɔmprɛhɛnsif ɛn fɔwad-luk kɔmplians fɔm we de mit di glob ɔl rigyuletɔri rikwaymɛnt dɛn akɔdin to di men mɛdikal makɛt dɛn.
FDA 510(k) Kliareshɔn
Joytech dɔn te we i dɔn mek wan strɔng prezɛns na di US makit, wit ɔl wi kɔr prodak layn dɛn we FDA dɔn ɔlrɛdi klia ɛn aktiv wan fɔ saplae to di glob patna dɛn. We wi de bil pan dis sɛtifiket fawndeshɔn, wi de kɔntinyu fɔ invɛst insay prɔdak inovashɔn ɛn rigyuletɔri rinuɛl fɔ mit di klinik nid dɛn we de evolv ɛn di patna-spɛsifi k prɔjek dimand dɛn.
Insay 2025, wi bin mek wi FDA pɔtfɔlio bɔku wit sɔm nyu sɛtifiket dɛn:
Tubeless upper arm blood pressure monitors — we de gi ɛnhans pɔtabiliti ɛn yuz ɛkspiriɛns.
Big-am dijital BP monita (DBP‐6186 / 6286B) — we dɛn mek fɔ ɛkstend an saiz (40–56 cm), wit Bluetooth opshɔn dɛn.
Kɔmpreshɔn nɛbulayz (NB‐1100 to NB‐1103) — FDA-klia ɔnda Prodakt Kɔd CAF, we de sɔpɔt rilibul respiratɔri tɛrapi na os ɔ na klinik.
EU MDR Sɛtifikeshɔn
Joytech de pan di fɔs Chaynish manifakta dɛn we gɛt EU MDR sɛtifiket ɔnda di nyu rigyuleshɔn. Insay Epril 2022 , wi bin gɛt wi fɔs MDR sɛtifiket frɔm TÜV SÜD, we kɔba prɔdak dɛn lɛk dijital tɛmɔmɔta, infrarɛd tɛmɔmɔta (ear & fɔrɛst), brɔst pɔmp, ɛn nɔ-invasiv blɔd prɛshɔn monita—we mak di fɔs MDR aprɔval na Chaina fɔ sɔm kategori dɛn we inklud ilɛktronik tɛmɔmɔta ɛn brɔst pɔmp.
Frɔm da tɛm de, wi dɔn kɔntinyu fɔ mek wi MDR-sɛtifiket pɔtfɔlio bɔku ɛvri ia. Bay Ɔktoba 2023 , ɔl di nyu jɛnɛreshɔn blɔd prɛshɔn monita ɛn tɛmɔmɔta dɛn bin dɔn gɛt CE (MDR) aprɔval. As of Febuari 2025 , wi nɔmba 4 batch fɔ sɛtifiket prodak dɛn inklud:
Dis ɛkspɛnshɔn we de go bifo de sho Joytech in dip kɔmitmɛnt fɔ kɔmplians, prodak inovashɔn, ɛn rigyuletɔri ɛksɛlɛns. Wi ful prodak layfsaykl—dizayn, tɛst, manufakchurin, dɔkyumentri, ɛn post-maket sɔvɛlayshɔn—mit di Yurop in strɔng standad dɛn, we de gi wi patna dɛn pawa wit sɛtifiket, rɛdi fɔ makɛt sɔlvishɔn ɔlsay na di EU.
Ɔda Rigyuletɔri Stɛndad dɛn
Wi manufakchurin prɔses dɛn gɛt sɛtifiket ɔnda ISO 13485 ɛn MDSAP , we de mit di rigyuletɔri nid dɛn fɔ di US, Kanada, Ɔstrelia, Japan, ɛn Brazil.
Dɔn bak, Joytech prodak dɛn kin gri bak wit di NMPA (Chaina), RoHS, ɛn REACH dairektv dɛn, we de mit di sef, envayrɔmɛnt, ɛn dɔkyumentri standad dɛn ɔlsay na Eshia ɛn di EU.
Wetin I Min fɔ Wi Patna dɛn？
Fɔ wok wit Joytech min mɔ pas fɔ jɔs sɔs wan prɔdak—i min fɔ gɛt stratejik patna we ɔndastand di kɔmplisiti dɛn fɔ intanashɔnal kɔmplians.
v Lɔwa rigyuletɔri risk ɛn kɔst – Wi rɛdi fɔ go sɛtifiket ɛn ɛkspiriɛns wit glob ɔdit de ridyus di lod pan yu lokal rɛjista prɔses.
v Fasta makɛt akses – Wit divays dɛn we dɛn dɔn sɛtifiket bifo tɛm, yu kin lanch na yu target rijyɔn dɛn wit big spid ɛn smɔl dilɛys.
v Kastomayz tɛknikal ɛn klinik sɔpɔt – Frɔm tɛknikal dɔkyumentri to klinik data, wi in-haus rigyuletɔri tim de gi tayla sɔpɔt fɔ mit yu kɔntri-spɛsifi k rikwaymɛnt dɛn.
v Prɔvab kwaliti ɛn ɔdit rɛdi – Wi kwaliti sistɛm dɔn pas bɔku tɔd-pati ɔdit, ɛn wi dɔkyumentri de ɔltɛm kip ɔdit-rɛdi, fɔ mek shɔ se transparency ɛn efyushɔn.
WETIN FƆ DU: As di rigyuleshɔn dɛn de chenj, na so wi go chenj. Joytech dɔn mekɔp in maynd fɔ kɔntinyu fɔ mek in glob ɔl kɔmplians rodmap bɔku wit sɛtifiket dɛn lɛk FDA ɛn MDR —fɔ mek shɔ se wi patna dɛn gɛt akses we nɔ gɛt ɛnitin fɔ du wit sɛtifiket, ay kwaliti mɛdikal divays dɛn na di makit dɛn we dɛn dɔn rigul.
Wi dɔn ɔlrɛdi gɛt sɛtifiket dɛn akɔdin to di big big rijyɔn dɛn na di wɔl, lɛk Nɔt Amɛrika, di EU, Eshia, ɛn ɔda say dɛn.
Yu want fɔ no if wi gɛt sɛtifiket na yu makit?
Yu de luk fɔ wan rigyuletɔri-rɛdi OEM/ODM sɔlvishɔn?
Kɔnekt wit wi tim tide fɔ fɛn di ditel dɛn bɔt di prɔdak sɛtifikeshɔn, di tɛknikal dɔkyumentri, ɛn di sɔlv dɛn we dɛn mek fɔ yu prɔjek. Wit Joytech, komplians bi yu kompititiv advantej.
