Views: 0 Author: Site Editor Bɔli waati: 2026-01-13 Bɔyɔrɔ: Yɔrɔ
Ikomi jigiya bɛ ka bonya denbatigiw ni denw ladonni na, o la, fɛn dilannenw sugandili tɛ kɛ sɔngɔ dɔrɔn de fɛ tugun. Lakanali, sariyaw labatoli, ani baarakɛlaw ka dannaya kɛra fɛn latigɛlenw ye—kɛrɛnkɛrɛnnenya la, sɔngɔko siratigɛ la. O jiginni in de y’a to sinji pɔnpe minnu bɛ se ka furakɛli kɛ , minnu sɛgɛsɛgɛra sariya gɛlɛnw kɔnɔ i n’a fɔ FDA ka yamaruya ani Health Canada furakɛli minɛnw ka lase , olu ka di ka caya ka taa a fɛ fɛn dilannikɛlaw fɛ minnu sinsinnen bɛ jogoɲumanya kan ani sannikɛla ŋanaw fɛ diɲɛ kɔnɔ.
Sinna pɔnpe min bɛ se ka kɛ furakɛli la, o tɛ ɲɛfɔ a yecogo walima a feereli kan fɛ. A bɛ ɲɛfɔ ni sariyaw ye.
Suguw la i n’a fɔ Ameriki ani Kanada, barajuru pɔnpe minnu bɛ baara kɛ ni fanga ye, olu bɛ labɛn i n’a fɔ furakɛli minɛnw . Walasa ka don o suguw la, fɛn dilannenw ka kan ka sariyaw lajɛ cogo labɛnnen na, k’a jira ko u bɛ lakana, baarakɛcogo, taamasiyɛnw, ani jogoɲini sariyaw labato.
Aw fɛ, o kɔrɔ ye ka fura dɔ sugandi min jateminɛna a yɛrɛma furakɛli minɛnw hukumu kɔnɔ minnu lakodɔnnen don — sanni ka kɛ feerekɛla ka minɛn ye min bilalen bɛ kɛnɛyako baara kama.
Sinna pɔnpe minnu saniyalen don U.S. FDA fɛ , olu bɛ jate furakɛli minɛnw ye minnu bɛ wele ko Class II , o bɛ 510(k) labɔli kɛcogo de wajibiya. O b’a jira ko minɛn in bɛ sariyaw labato minnu bɛ sirataama, wa a lakanani n’a baarakɛcogo bɛ bɛn kosɛbɛ furakɛli minɛnw ma minnu bɛ feere sariya sira fɛ.
Kanada jamana na, Health Canada furakɛli minɛnw ka lase bɛ ɲini fɛɛrɛko dalilu sɛbɛnnenw fɛ ani jogoɲumanya ɲɛnabɔcogo min bɛ bɛn sariya ma, o b’a to fura in bɛ bɛn jamana ka sariyaw ma furakɛli lakanani ni baarakɛcogo kan.
Nin sɔnniw faralen ɲɔgɔn kan, u b’a jira ko barajuru pɔnpe tɛmɛna sariyasen dɔw kan minnu ka gɛlɛn kosɛbɛ diɲɛ sugu la — o bɛ dannaya jusigilan barikama di baarakɛlaw ka baarakɛcogo ma ani ka jɔyɔrɔba di a ma.
Denbatigiw ladonni suguw la minnu ka bon kosɛbɛ, dannaya de nafa ka bon. Sinna pɔnpe minnu bɛ se ka kɛ dɔgɔtɔrɔso la, olu ka di u ye barisa u:
A jira ko i bɛ furakɛli sariyaw labato minnu lakodɔnnen don diɲɛ kɔnɔ
Ka dɔ bɔ sariyaw ni sugu doncogo dankarili la
Dɛmɛ don baarakɛlaw ka taamasiyɛn ja la min jɔlen bɛ lakana ni kunkanbaaraw kan
Aw bɛ bɛn bangebagaw ka jigiya ma minnu bɛ kunnafoni sɔrɔ ani sannikɛlaw minnu bɛ kɛnɛyako ɲɛnabɔ
Marka ni feerekɛlaw fɛ, nin seereyaw hakɛ in tɛ fɛɛrɛko wajibiyalen dɔrɔn ye—a ye danfaralan ye fɛɛrɛko siratigɛ la.
I n’a fɔ nin fɛɛrɛ in misali, . LD-3010L barajuru pɔnpe fila min dilanna Joytech fɛ, o dilannen don ani a dilannen don ka kɛɲɛ ni FDA ni Health Canada furakɛli minɛnw ka ɲininiw ye , o b’a to a bɛ se ka kɛ barajuru pɔnpe ye min bɛ se ka kɛ furakɛli la.
O fura in bɛ baarakɛlaw ka baarakɛcogo nɔgɔlen ni baarakɛlaw ka fɛn dilanni sariyaw fara ɲɔgɔn kan, ka fɛɛrɛ dɔ di min bɛ baarakɛcogo, dannaya ani sariyaw sigicogo bɛn ɲɔgɔn ma—a bɛnnen don kosɛbɛ denbatigiw ladonni portifaliw ma minnu ka fisa.
Sinna pɔnpe minnu bɛ se ka kɛ furakɛli la, olu bɛ fɛn caman jira ka tɛmɛ baarakɛcogo ɲɛtaa kan. U bɛ cɛsiri jira ka ɲɛsin sariya labatoli ma, lakana ma, ani baarakɛlaw ka sariyaw ma, denbatigiw ladonni suguya ɲumanw bɛ ka minnu ɲini ka taa a fɛ.
Ni aw bɛ denbatigiw ladoncogo ɲumanba dɔ jɔ walima ka dɔ fara a kan, aw bɛ a sugandi FDA ni Health Canada ka seereyaw bɛ sinji pɔnpe minnu na, minnu bɛ se ka kɛ furakɛli la, olu bɛ dɛmɛ ka dannaya kuntaalajan sɔrɔ, ka dannaya sɔrɔ sariyaw la, ani ka dannaya sɔrɔ u tɔgɔlafɛnw kan diɲɛ suguw la minnu bɛ se ka ɲɔgɔn sɔrɔ.