Ni diɲɛ furakɛli minɛnw sariyaw bɛ ka gɛlɛya ka taa a fɛ, jamana kɔkan tɔn minnu bɛ don Erɔpu ni Ameriki suguw la, olu man kan ka dantigɛli gɛlɛnw dɔrɔn dafa ka kɔn sugu ɲɛ, nka u ka kan ka Flying Inspection (No Notice Inspection) ani Post-Market Surveillance (PMS) fana ɲɛnabɔ. Danfaraba bɛ sariyaw kɔnɔ, sɛgɛsɛgɛli kɛcogo ani jalakiw la Ameriki FDA ni EU MDR/IVDR cɛ.
FDA ye mun ye (US Food and Drug Administration) ? FDA bɛ furakɛli minɛnw lakanani ni u nafacogo ɲɛnabɔ Ameriki jamana na. Minɛn fanba la, dilanbagaw ka kan ka 510(k) sɛbɛn di walasa k’a jira k’u ka fɛn dilannen lakananen don, ko a bɛ baara kɛ, wa a bɛ bɛn kosɛbɛ minɛn ma min dabɔra kɔrɔ.
MDR (Medical Device Regulation) ye min ye ? MDR ye Erɔpu tɔnba ka sariya ye furakɛli minɛnw ko la, min bɛ MDD kɔrɔ (Medical Device Directive) nɔ bila. A ka sariyaw ka gɛlɛn kɛnɛyaso jateminɛni na, sugu kɔfɛ kɔlɔsili, ani fɛɛrɛ sɛbɛnw walasa ka banabagatɔw lakanani ni kɛnɛya sabatili sabati.
FDA ni MDR fila bɛɛ lajɛlen taamacogo ka gɛlɛn—nka a nafa ka bon kosɛbɛ. Joytech la, an ye diɲɛ sariya labatoli sira barikama dɔ jɔ walasa k’an ka jagokɛɲɔgɔnw dɛmɛ u ka nin sariya gɛlɛnw dafa ni dannaya ye. I mana dɔ fara i ka baara kan Ameriki walima i donna EU kɔnɔ MDR kɔnɔ, an ka fɛn dilannenw, an ka fɛɛrɛ sɛbɛnw, ani sariyaw dɔnniya bɛ yan walasa k’i dɛmɛ.
An bɛ min na ?
Joytech la, an ye sariyasunba barikama dɔ sigi senkan walasa ka fanga di an jɛɲɔgɔnw ma diɲɛ kɔnɔ. Joytech ye sariya labatoli hukumu dɔ jɔ min bɛ se ka kɛ sababu ye ka diɲɛ sariyaw labato furakɛli suguyabaw kɔnɔ.
FDA 510(k) Labɛnni
Joytech ye jɔyɔrɔba sigi Ameriki sugu la kabini tuma jan, an ka fɛn dilannen jɔnjɔnw bɛɛ FDA ye u saniya kaban , wa u bɛ di diɲɛ jɛɲɔgɔnw ma ni timinandiya ye. Ka da nin jusigilan sɛgɛsɛgɛlen in kan, an bɛ to ka wari bila fɛn dilanni na ani sariyaw kurayali la walasa ka kɛnɛyaso magow ɲɛnabɔ minnu bɛ ka wuli ka taa a fɛ ani jɛɲɔgɔn kɛrɛnkɛrɛnnenw ka porozɛ ɲininiw.
San 2025, an ye an ka FDA ka baarakɛminɛnw bonya ni seere kura caman ye:
Bolo sanfɛla tansiyɔn jateminɛnan minnu tɛ tubabukan na — olu bɛ se ka taa ni a ye ani ka baarakɛcogo ɲɛ.
BP nimɔrɔlan belebelebaw (DBP‐6186 / 6286B) — minnu dabɔra bolo janyalenw hakɛ kama (santimɛtɛrɛ 40–56), ni bulutu suganditaw ye.
Compresseur nebulizers (NB‐1100 ka se NB‐1103) — FDA ye u labɛn ka kɛɲɛ ni Product Code CAF ye, minnu bɛ ninakili furakɛli dafalen dɛmɛ so kɔnɔ walima dɔgɔtɔrɔsow la.
EU ka MDR ka seereyaw
Joytech bɛ cɛ Sinuwa fɛn dilannikɛla fɔlɔw minnu ye EU MDR seereyaw sɔrɔ sariya kura in kɔnɔ. Awirilikalo san 2022 , an y’an ka MDR seere fɔlɔ sɔrɔ ka bɔ TÜV SÜD fɛ, min bɛ fɛnw ɲɛfɔ i n’a fɔ funteni jateminɛnan nimɔrɔma, funteni jateminɛnan infirɛri (tulo & ɲɛda), sinji pɔnpew, ani tansiyɔn jateminɛnan minnu tɛ fɛn minɛ — o ye MDR ka sɔnni fɔlɔ taamasiyɛn ye Sinuwa jamana na, suguya caman na, i n’a fɔ funteni jateminɛnan ɛntɛrinɛti ani sinji pɔnpe.
Kabini o waati, an tora ka dɔ fara an ka MDR-seereyaw kan san o san. San la 2023 Ɔkutɔburukalo , tansiyɔn jateminɛnanw ni funteni jateminɛnanw bɛɛ tun ye CE (MDR) ka yamaruya sɔrɔ. Kabini san 2025 feburuyekalo la , an ka fɛn dilannenw kulu naaninan minnu sɛgɛsɛgɛra, olu ye :
Nin yiriwali min bɛ senna, o b’a jira ko Joytech cɛsirilen don kosɛbɛ sariya labatoli la, fɛn dilanni na, ani sariyasunw ka ɲɛtaa la. An ka fɛn dilannenw ka ɲɛnamaya kɛcogo dafalen — u dilanni, u kɔrɔbɔli, u dilanni, u sɛbɛnni, ani u kɔlɔsili sugu kɔfɛ — o bɛ Erɔpu sariyaw labato minnu ka gɛlɛn kosɛbɛ, ka fanga di an jɛɲɔgɔnw ma ni furaw ye minnu sɛgɛsɛgɛlen don, minnu labɛnnen don ka feere sugu la UE jamana bɛɛ kɔnɔ.
Sariyasen wɛrɛw
An ka fɛn dilanni taabolo sɛgɛsɛgɛlen don ISO 13485 ani MDSAP kɔnɔ , minnu bɛ Ameriki, Kanada, Ɔsitarali, Japon ani Berezili ka sariyaw mago ɲɛ.
Ani fana, Joytech ka fɛn dilannenw fana bɛ bɛn NMPA (Sina), RoHS, ani REACH ka cikanw ma, minnu bɛ lakana, sigida ani sɛbɛnni sariyaw dafa Azi jamana bɛɛ kɔnɔ ani EU.
A kɔrɔ ye min ye an ka jɛɲɔgɔnw bolo？
Baara kɛli ni Joytech ye, o kɔrɔ tɛ fɛn dɔ sɔrɔyɔrɔ dɔrɔn ye — o kɔrɔ ye ka jɛɲɔgɔn fɛɛrɛbɔlen sɔrɔ min bɛ diɲɛ sariya labatoli gɛlɛyaw faamu.
v Sariyasunba faratiw ni musakaw dɔgɔyali – An ka seereyaw labɛnnenw ani an ka dɔnniya sɔrɔli diɲɛ jatebɔw la, o bɛ dɔ bɔ doni la aw ka sigida tɔgɔsɛbɛnni taabolo kan.
v Sugu sɔrɔli teliya – Ni minɛn minnu sɛgɛsɛgɛra ka kɔn, i bɛ se ka daminɛ i ka laɲini maraw la ni teliyaba ye ani ni waati dɔɔnin ye.
v Fɛɛrɛ ni kɛnɛyako dɛmɛni min bɛ kɛ ka kɛɲɛ ni i yɛrɛ sago ye – K’a ta fɛɛrɛko sɛbɛnw na ka se kɛnɛyaso kunnafoniw ma, an ka sigida kɔnɔ sariyasunba bɛ dɛmɛ di min bɛ kɛ ka kɛɲɛ ni i ka jamana kɛrɛnkɛrɛnnenw ka ɲininiw ye.
v Jogoɲumanya ni jatebɔ labɛnni min sɛgɛsɛgɛra – An ka jogoɲumanya siratigɛ tɛmɛna mɔgɔ sabananw ka jatebɔ caman kan, wa an ka sɛbɛnw bɛ mara jatebɔ labɛnni na tuma bɛɛ, ka kɛnɛya ni baarakɛcogo ɲuman sabati.
DANTAGA: Ni sariyaw bɛ ka wuli, an fana bɛna taa ɲɛ. Joytech b’a cɛsiri ka taa a fɛ k’a ka diɲɛ sariya labatoli siraba bonya ni seereyaw ye i n’a fɔ FDA ani MDR —k’a lajɛ ko an jɛɲɔgɔnw bɛ se ka furakɛli minɛnw sɔrɔ minnu sɛgɛsɛgɛlen don, minnu ka ɲi kosɛbɛ suguw kɔnɔ minnu bɛ sariya kɔnɔ.
An bɛ seereyaw sɔrɔ kaban diɲɛ marabaw kɔnɔ, Ameriki Woroduguyanfan, UE, Azi ani a kɔkan.
Aw b’a fɛ k’a dɔn ni an ye seere sɔrɔ aw ka sugu la wa?
Aw bɛ OEM/ODM furakɛcogo dɔ ɲini min labɛnnen don sariyaw la wa?
Aw ye jɛɲɔgɔnya kɛ ni an ka jɛkulu ye bi walasa ka fɛn dilannenw ka seereyaw kunnafoniw sɛgɛsɛgɛ, fɛɛrɛko sɛbɛnw, ani furaw minnu bɛ bɛn aw ka porozɛ ma. Joytech fɛ, sariya labatoli bɛ kɛ i ka nafa ye ɲɔgɔndan na.
