Intsinzi ya Joytech kwisi yose: MDR & FDA Impamyabumenyi kumurongo wuzuye wibicuruzwa

Hamwe no gukaza umurego mu kugenzura ibikoresho by’ubuvuzi ku isi, amasosiyete yo mu mahanga yinjira ku masoko y’Uburayi n’Amerika ntagomba kuba yujuje gusa ibyangombwa bisabwa mbere y’isoko, ahubwo agomba no guhangana n’ubugenzuzi bukomeye bwo kuguruka (No Notice Inspection) hamwe n’ubushakashatsi bwakozwe nyuma y’isoko (PMS). Hariho itandukaniro rikomeye muburyo bwo kugenzura, uburyo bwo kugenzura n'ibihano hagati ya Amerika FDA na EU MDR / IVDR.

Niki FDA (Ikigo gishinzwe ibiryo n'ibiyobyabwenge muri Amerika) ?
FDA igenga umutekano nibikorwa byubuvuzi muri Amerika. Kubikoresho byinshi, ababikora bagomba gutanga 510 (k) kugirango bagaragaze ko ibicuruzwa byabo bifite umutekano, bikora neza, kandi bihwanye cyane nigikoresho cyemewe.

MDR ni iki (Amabwiriza agenga ibikoresho byubuvuzi) ?
MDR ni amabwiriza y’ubumwe bw’ibihugu by’i Burayi agenga ibikoresho by’ubuvuzi, asimbuza icyahoze ari MDD (Amabwiriza y’ubuvuzi). Ifite ibisabwa bikomeye mu isuzuma ry’amavuriro, kugenzura nyuma y’isoko, hamwe n’ibyangombwa bya tekiniki kugira ngo umutekano w’abarwayi urusheho gukorera mu mucyo.

Kugenda byombi FDA na MDR biragoye - ariko birakomeye. Kuri Joytech, twashizeho uburyo bukomeye bwo kubahiriza isi kugirango dufashe abafatanyabikorwa bacu mu bucuruzi kubahiriza aya mahame asabwa twizeye. Waba waguka muri Amerika cyangwa ukinjira muri EU munsi ya MDR, ibicuruzwa byacu byemewe, ibyangombwa bya tekiniki, hamwe n'ubuhanga bwo kugenzura biri hano kugirango bigushyigikire.

W ingofero ​​ ​​?

Kuri Joytech, twashizeho urufatiro rukomeye rwo kugenzura ibyo duha imbaraga abafatanyabikorwa bacu ku isi. Joytech yubatse urwego rwuzuye kandi rureba imbere rwujuje ibisabwa ku isi hose ku masoko akomeye y’ubuvuzi.

FDA 510 (k) Kwemeza

Joytech imaze igihe kinini igaragara ku isoko ry’Amerika, hamwe n’ibicuruzwa byacu byose byibanze FDA imaze guhanagura kandi igahabwa abafatanyabikorwa ku isi. Twiyubakiye kuri uru rufatiro rwemewe, dukomeje gushora imari mu guhanga ibicuruzwa no kuvugurura amabwiriza kugira ngo duhuze ibikenerwa mu mavuriro hamwe n’ibisabwa by’umushinga.

Muri 2025, twaguye portfolio ya FDA hamwe nimpamyabumenyi nshya:

• Tubeless yo hejuru yamaraso yumuvuduko ukurikirana - itanga uburyo bworoshye bwogukoresha hamwe nuburambe bwabakoresha.

• Ikurikiranwa ryamaboko manini ya BP (DBP - 6186 / 6286B) - yagenewe ubunini bwamaboko (cm 40-56), hamwe na Bluetooth.

• Compressor nebulizers (NB - 1100 kugeza NB - 1103) - FDA yahanaguwe na Code Code CAF, ishyigikira ubuvuzi bwubuhumekero bwizewe murugo cyangwa mumavuriro.

Icyemezo cya MDR cya EU

Joytech ari mubambere bambere mubushinwa babonye ibyemezo bya EU MDR nkuko amabwiriza mashya abiteganya. Muri Mata 2022 , twabonye icyemezo cya mbere cya MDR cyatanzwe na TÜV SÜD, gikubiyemo ibicuruzwa nka tometrometrike ya digitale, ibipimo bya termometero (ugutwi & agahanga), pompe yamabere, hamwe n’ikurikiranabikorwa ry’umuvuduko ukabije w’amaraso - ibyo bikaba byemejwe bwa mbere MDR mu Bushinwa mu byiciro byinshi birimo ibipimo bya elegitoroniki na pompe.

Kuva icyo gihe, twakomeje kwagura MDR yemewe na portfolio buri mwaka. Kugeza mu Kwakira 2023 , abakurikirana umuvuduko ukabije w'amaraso hamwe na termometero zimaze kwemerwa na CE (MDR). Kugeza muri Gashyantare 2025 , icyiciro cya kane cyibicuruzwa byemewe birimo:

• bose Nebulizers

• Ikurikirana ry'umuvuduko w'amaraso wa ECG

• Ikimenyetso cyingenzi

• Ibikoresho byose bifasha Bluetooth

• Amabere yose

Uku kwaguka gukomeje kwerekana ubushake bwa Joytech bwo kubahiriza, guhanga ibicuruzwa, no kuba indashyikirwa mu mabwiriza. Ibicuruzwa byacu byuzuye mubuzima - gushushanya, kugerageza, gukora, gukora inyandiko, no kugenzura nyuma yisoko - byujuje ubuziranenge bw’Uburayi, biha imbaraga abafatanyabikorwa bacu ibisubizo byemewe, byiteguye ku isoko mu bihugu by’Uburayi.

Ibindi bipimo ngenderwaho

Ibikorwa byacu byo gukora byemewe muri ISO 13485 na MDSAP , byujuje ibisabwa muri Amerika, Kanada, Ositaraliya, Ubuyapani, na Berezile.

Ibicuruzwa bya Joytech nabyo bihuye nubuyobozi bwa NMPA (Ubushinwa), RoHS, na REACH, bwujuje ubuziranenge bwumutekano, ibidukikije, ninyandiko muri Aziya no muburayi.

Icyo Bisobanura Abafatanyabikorwa bacu？

Gukorana na Joytech ntibisobanura ibirenze gushaka ibicuruzwa-bivuze kubona umufatanyabikorwa wunvikana wunvikana ningorabahizi zo kubahiriza mpuzamahanga.

v Ingaruka zo kugenzura ibiciro hamwe nigiciro - Impamyabumenyi zacu-twiteguye-kujya hamwe nuburambe hamwe nubugenzuzi bwisi yose bigabanya umutwaro kubikorwa byawe byo kwiyandikisha.

v Kwihuta kw'isoko ryihuse - Hamwe nibikoresho byabanje kwemezwa, urashobora gutangiza mukarere ugamije ufite umuvuduko mwinshi no gutinda gake.

v Inkunga yihariye ya tekiniki na clinique - Kuva mubyangombwa bya tekiniki kugeza kumibare yubuvuzi, itsinda ryacu rishinzwe kugenzura ibikorwa byimbere mu gihugu ritanga ubufasha bwihariye kugirango uhuze ibyifuzo byigihugu cyawe.

v Byemejwe ko byujuje ubuziranenge no kugenzura - Sisitemu yacu yubuziranenge yatsindiye ubugenzuzi bw’abandi bantu batatu, kandi inyandiko zacu zihora zigenzurwa neza, zitanga umucyo no gukora neza.

UMWANZURO:
Nkuko amabwiriza agenda ahinduka, natwe tuzagenda. Joytech yiyemeje gukomeza kwagura igishushanyo mbonera cy’isi yose hamwe n’impamyabumenyi nka FDA na MDR - kwemeza ko abafatanyabikorwa bacu badahwema kubona ibikoresho by’ubuvuzi byemewe kandi byujuje ubuziranenge ku masoko yagenwe.

Dufite ibyemezo mu turere twinshi two ku isi, harimo Amerika y'Amajyaruguru, Umuryango w'ubumwe bw’ibihugu by’Uburayi, Aziya, ndetse n’ahandi.

Ushaka kumenya niba twemejwe ku isoko ryawe?

Urashaka igisubizo cyateguwe na OEM / ODM igisubizo?

Ihuze nitsinda ryacu uyumunsi kugirango ushakishe amakuru yerekana ibicuruzwa, ibyangombwa bya tekiniki, hamwe nibisubizo byateganijwe kumushinga wawe. Hamwe na Joytech, kubahiriza biba inyungu zawe zo guhatanira.