Esiane sɛ wiase nyinaa nnuruyɛ mfiri ho mmara reyɛ den kɛse nti, ɛnyɛ sɛ ɛsɛ sɛ amannɔne nnwumakuw a wɔrehyɛn Europa ne Amerika gua so no di ahwehwɛde a ɛyɛ den a wɔpene so ansa na wɔatɔn no nko, na mmom ɛsɛ sɛ wodi Flying Inspection (No Notice Inspection) ne Post-Market Surveillance (PMS) a emu yɛ den nso ho dwuma. Nsonsonoe kɛse wɔ mmara mu ntease, akwan a wɔfa so hwehwɛ nneɛma mu ne asotwe ahorow mu wɔ U.S. FDA ne EU MDR/IVDR ntam.
Dɛn ne FDA (US Food and Drug Administration) ? FDA na ɛhwɛ ahobammɔ ne sɛnea ɛyɛ adwuma yiye wɔ nnuruyɛ mfiri ahorow mu wɔ United States. Wɔ mfiri dodow no ara fam no, ɛsɛ sɛ wɔn a wɔyɛ no de 510(k) ma de kyerɛ sɛ wɔn nneɛma no yɛ nea ahobammɔ wom, etu mpɔn, na ɛne mfiri a wɔapene so dedaw no yɛ pɛ kɛse.
Nea ɛyɛ MDR (Medical Device Regulation) ? MDR yɛ Europa Aman Nkabom no mmara a ɛfa nnuruyɛ mfiri ho, na ɛde kan MDD (Medical Device Directive) ananmu. Ɛwɔ ahwehwɛde ahorow a emu yɛ den a ɛfa ayaresabea nhwehwɛmu, gua akyi nhwehwɛmu, ne mfiridwuma ho nkrataa a wɔde hwɛ ma ayarefo ahobammɔ a ɛkorɔn ne nea ɛda adi pefee ho.
FDA ne MDR nyinaa mu a wobɛfa so no yɛ nea ɛyɛ den —nanso ɛho hia kɛse. Wɔ Joytech no, yɛayɛ wiase nyinaa mmara sodi nhyehyɛe a ɛyɛ den de aboa yɛn adwumayɛfoɔ ma wɔadu saa gyinapɛn a ɛhwehwɛ pii yi ho wɔ ahotosoɔ mu. Sɛ́ ebia woretrɛw mu akɔ U.S. anaasɛ worekɔ EU mu wɔ MDR ase no, yɛn nneɛma a wɔagye atom, mfiridwuma ho nkrataa, ne mmara ho nimdeɛ wɔ ha sɛ ɛbɛboa wo.
Nea Yɛwɔ ?
Wɔ Joytech no, yɛde mmara fapem a ɛyɛ den asi hɔ a ɛbɛma yɛn ahokafoɔ tumi wɔ wiase nyinaa. Joytech ayɛ nhyehyɛe a ɛfa mmara sodi ho a ɛkɔ akyiri na ɛhwɛ daakye a ɛdi wiase nyinaa mmara ahwehwɛdeɛ so wɔ aduruyɛ gua akɛseɛ so.
FDA 510(k) Afiri a Wɔde Ma
Joytech de bere tenten ayɛ nea ɛyɛ den wɔ U.S. gua so, a yɛn nneɛma atitiriw no nyinaa FDA agye dedaw na wɔde nsiyɛ de ama wiase nyinaa ahokafo. Yɛde saa fapem a wɔagye atom yi si so no, yɛkɔ so de sika hyɛ nneɛma foforo a wɔyɛ ne mmara foforo mu de di ayaresabea ahiade a ɛrekɔ so ne adwuma pɔtee bi ahwehwɛde ahorow ho dwuma.
Wɔ afe 2025 mu no, yɛtrɛw yɛn FDA portfolio mu denam adansedi foforo pii so:
Tubeless upper arm mogya mmoroso monitors — ma enhanced portability ne osuahu a ɔde di dwuma.
Digyital BP monitors a ɛwɔ nsa akɛse (DBP‐6186 / 6286B) — wɔayɛ ama nsa akɛse a wɔatrɛw mu (40–56 cm), a Bluetooth a wobetumi apaw.
Compressor nebulizers (NB‐1100 to NB‐1103) — FDA-pene so wɔ Product Code CAF ase, a ɛboa ɔhome ayaresa a wotumi de ho to so wɔ fie anaa ayaresabea ahorow.
EU MDR Adansedi krataa
Joytech ka Chinafo a wodii kan nyaa EU MDR adansedi krataa wɔ mmara foforo no ase no ho. Wɔ April 2022 mu no, yɛnyaa yɛn MDR adansedie krataa a ɛdi kan no firii TÜV SÜD hɔ, a ɛfa nneɛma te sɛ digyital thermometers, infrared thermometers (aso & moma so), nufu mu pɔmpɛ, ne mogya mmorosoɔ a ɛnyɛ nea wɔde hyɛ nipadua mu —a ɛhyɛ MDR pene a ɛdi kan wɔ China ma akuw ahodoɔ pii a ɛlɛtrɔnik thermometers ne nufu mu pɔmpɛ ka ho.
Efi saa bere no, yɛakɔ so atrɛw yɛn MDR-certified portfolio mu afe biara. Eduu October 2023 , na awo ntoatoaso foforo a wɔde hwɛ mogya mmoroso ne mfiri a wɔde kyerɛ ɔhyew a ɛwɔ nipadua no mu nyinaa anya CE (MDR) pene. Ɛde besi February 2025 , yɛn nneɛma a ɛto so anan a wɔagye atom no bi ne:
Saa ntrɛwmu a ɛkɔ so yi da Joytech botae a emu dɔ adi sɛ ɛbɛma wɔadi mmara so, ayɛ nneɛma foforo, ne mmara a ɛkyɛn so. Yɛn nneɛma nkwa nna nyinaa —nsusuwii, sɔhwɛ, nneɛma a wɔyɛ, nkrataa, ne gua akyi hwɛ —di Europa gyinapɛn a emu yɛ den sen biara ho dwuma, na ɛma yɛn ahokafo tumi de ano aduru a wɔagye atom, a wɔasiesie sɛ wɔbɛtɔn wɔ EU nyinaa.
Mmarahyɛ Gyinapɛn Afoforo
Yɛn nneɛma a yɛyɛ no wɔ adansedi krataa wɔ ISO 13485 ne MDSAP ase , na edi U.S., Canada, Australia, Japan, ne Brazil mmara ahiade ahorow ho dwuma.
Afei nso, Joytech nneɛma nso ne NMPA (China), RoHS, ne REACH akwankyerɛ hyia, na ɛdi ahobanbɔ, nneɛma a atwa yɛn ho ahyia, ne nkrataa gyinapɛn a ɛwɔ Asia ne EU nyinaa so.
Nea Ɛkyerɛ Ma Yɛn Mfɛfo？
Joytech a wo ne no bɛyɛ adwuma no kyerɛ pii sen sɛ wubenya ade bi afi baabi kɛkɛ —ɛkyerɛ sɛ wubenya ɔhokafo a ɔyɛ ɔkwankyerɛfo a ɔte amanaman ntam mmara a wodi so no mu nsɛnnennen ase.
v Mmara mu asiane ne ɛka a ɛba fam – Yɛn adansedie a yɛasiesie sɛ yɛbɛkɔ ne osuahu a yɛwɔ wɔ wiase nyinaa akontabuo mu no brɛ adesoa a ɛwɔ wo mpɔtam hɔ dinkyerɛw nhyehyɛeɛ so no ase.
v Guadiɛ a ɛkɔ ntɛmntɛm – Sɛ wode mfiri a wɔadi kan agye atom a, wobɛtumi ahyɛ aseɛ wɔ mmeaeɛ a wode w’ani asi so no a ahoɔhare kɛseɛ ne akyɛdeɛ kakraa bi.
v Mfiridwuma ne ayaresabea mmoa a wɔayɛ no sɛnea wopɛ – Efi mfiridwuma ho nkrataa so kosi ayaresabea ho nsɛm so no, yɛn fie no mu mmarahyɛ kuw no de mmoa a wɔayɛ ama wo ma wobedi w’aman pɔtee ahwehwɛde ahorow ho dwuma.
v Wɔada no adi sɛ ɛyɛ papa ne akontabuo ahoboa – Yɛn su pa nhyehyɛeɛ no atwam wɔ nnipa a wɔto so mmiɛnsa akontabuo pii mu, na wɔde yɛn nkrataa no sie bere nyinaa sɛ ɛyɛ krado sɛ ɛbɛyɛ akontabuo, na ɛhwɛ ma ɛda adi na ɛyɛ adwuma yie.
AWIEI: Bere a mmara ahorow rekɔ so no, saa ara na yɛn nso yɛbɛyɛ. Joytech asi ne bo sɛ ɔbɛkɔ so atrɛw ne wiase nyinaa mmara sodi kwankyerɛ mu denam adansedi ahorow te sɛ FDA ne MDR —ahwɛ ahu sɛ yɛn ahokafo no benya aduruyɛ mfiri a wɔagye atom, a ɛkorɔn a wontwa mu wɔ gua ahorow a wɔahyɛ ho mmara so.
Yɛwɔ adansedi nkrataa dedaw wɔ wiase nyinaa mmeae atitiriw, a Amerika Atifi fam, EU, Asia, ne nea ɛboro saa ka ho.
Wopɛ sɛ wuhu sɛ yɛwɔ adansedi krataa wɔ wo gua so anaa?
Worehwehwɛ OEM / ODM ano aduru a wɔasiesie ama mmara?
Wo ne yɛn kuw no nni nkitaho nnɛ na hwehwɛ nneɛma ho adansedi ho nsɛm, mfiridwuma ho nkrataa, ne ano aduru a wɔayɛ ama wo dwumadi no. Joytech mu no, mmara a wodi so no bɛyɛ wo akansi mu mfaso.
