Tulafono faatonutonu

O masini fa'afoma'i e fa'atulafonoina i Kanata e le Health Canada's Therapeutic Products Directorate (TPD) ma i Amerika e le Food & Drug Administration (US-FDA). O masini fa'afoma'i ua fa'avasegaina i se tasi o Vasega 1 i le 4, lea o le Vasega 1 o lo'o fa'atusalia ai le tulaga aupito maualalo, ae o le Vasega 4 o lo'o sili ona lamatia. O oloa uma a le Solarc/SolRx UVB phototherapy ua fa'avasegaina o le "Vasega 2" i Kanata ma Amerika. Manatua: O le US-FDA o loʻo faʻaaogaina numera Roma nai lo numera mo nei vasega, o lea i Amerika, o masini Solarc o le "Visi II".

In Kanata, Vasega 2 masini e fa'atatau i le tele o fa'atonuga, e aofia ai: - Tausi i le Canadian Medical Device Regulations (CMDR) - Fa'atagaina maketi e ala i le laiseneina masini muamua ma tausaga ta'itasi - Mandatory ISO-13488 po'o ISO-13485 Quality System ma le tausaga lona tolu su'etusi a pati, ma Fa'atonu Fa'afitauli Lipoti. Ole lisi o laisene masini mo Solarc Systems e mafai ona maua ile Health Canada's Medical Devices License Listing website ile: www.mdall.ca. Kiliki "Active License Search", ma faʻaoga "Igoa Kamupani" (Solarc). I le isi itu, alu i le itulau autu a le Health Canada's Medical Device.

tusi¹: I Iulai-21-2008, Solarc e tolu Health Canada Medical Device Licenses (12783,62700,69833) na tuufaatasia i le tasi laisene (12783). Le “Aso Fa'amatalaga Muamua” mo masini uma se'i vagana le 1000‑Series ua aliali mai nei o Iulai-21-2008; e ui lava o nei masini na muamua laiseneina ia Iuni-16-2003 mo 62700 (500‑Series) ma Dec-02-2005 mo 69833 (100‑Series). Ia maitauina foi o le 1000‑Series na muamua laiseneina ia Feb-1993 e le "Health and Welfare Canada" i luga o le Avanoa #157340, aʻo leʻi oʻo i le tulafono fou a Kanata o Me 1998.

tusi²: O masini uma a le Solarc Systems 'UVB (UVB-Narrowband and UVB-Broadband) na maua le faamaoniga a le Health Canada e faaopoopo le "Vitamin D Deficiency" i le "Indications of Use" (tulaga o le soifua maloloina lea e mafai ona faasalalauina faaletulafono) i le Iulai 21, 2008 teuteuga ole Solarc ile Health Canada Device License #12783.

tusi³: I le aso 05 o Ianuari, 2011, na maua ai e Solarc le fa'atagaga a le Health Canada e fa'aopoopo le matou aiga masini lona 4, le E‑Series, i la matou Laisene Mea Fa'atonu a le Health Canada #12783. Solarc's Health Canada Medical Device License #12783 o lo'o fa'aalia ile pito i lalo ole itulau lenei.

I le ISA, Vasega II (Vaega 2) masini e fa'atatau i le tele o fa'atonuga, e aofia ai:

- O le tausisia o vaega talafeagai o le Code of Federal Regulations (CFR)

- Fa'atagaina o maketi e ala i le fa'aogaina muamua o le 510(k) ma le fa'ai'uga o le fa'atusatusaga tele.

- Tuuina atu lipoti o le Uluai & Suiga o Mea i le Nofoaga Autu mo masini ma le Soifua Maloloina (CDRH)

- Lisi o masini (Tasi ile numera o oloa)

– Fa'atonuina o le “GMP) Faiga Tulaga Lelei

– Fa'atonu Fa'amatalaga Fa'afitauli

E le fa'atagaina e le US-FDA le fa'aogaina o le 510(k) po'o isi fa'amatalaga fa'atulafonoina. Peita'i, e mafai ona maua fa'aletulafono lenei fa'amatalaga mai le US-FDA/CDRH upega tafa'ilagi. I le itu taumatau, tusi i lalo i Tools & Resources > Medical Device Databases, lea e mafai ai ona e suʻeina Faʻamatalaga Faʻamatalaga 510 (k) ma Mea Faʻatonu. Su'esu'e fa'aaoga le "Igoa Tagata Talosaga" (Solarc) po'o le "Igoa/Operator Igoa" (Solarc).

Fa'aoga so'oga nei i su'esu'ega fa'amaumauga a le FDA:

510(k) Su'esu'ega Fa'amaumauga

Su'esu'ega Fa'amaumauga o Fa'amaumauga o Masini

tusi¹: (faatatau i Amerika na'o)

I le 2011 ma le faʻaogaina o le FDA's 510 (k) process, Solarc na le manuia i lana taumafaiga e faʻaopoopo le "Vitamin D Deficiency" i le "Indications for Use" ona e leai se mea faʻatusatusa "predicate" (muamua) masini na i ai, ma ia maua le faʻatagaga. semanu e mana'omia ai se tusi talosaga "PMA" o le Fa'atagaga a le Mu'ai Fa'atau. I Amerika, Solarc o lea lē fa'ataga e fa'alauiloa masini mo le "Vitamin D Deficiency"; ae na'o mo na'o le "Fa'ailoga mo le Fa'aaogaina" o le psoriasis, vitiligo, ma le eczema. I lenei tulaga, o le "Vitamin D Deficiency" ua manatu o se "off-label" le faʻaaogaina, ae e tusa lava po o le a, e mafai lava e se fomaʻi ona talosagaina faʻamatalaga e uiga i le faʻaogaina o igoa, ma ua faʻatagaina faaletulafono le fomaʻi e tusi se talavai mo le maʻi. ia maua le oloa. O lenei manatu ua ta'ua o le "fa'ata'ita'iga fa'afoma'i", o lona uiga e mafai e se foma'i ona fa'atonu pe fa'atonu so'o se oloa fa'atau fa'aletulafono mo so'o se fa'aoga i fafo atu o igoa latou te manatu e sili ona lelei mo le ma'i.

Fa'atonuga a Fomai

O talavai a foma'i e filifili mo uta i tuatusi Kanata ma Fa'ava-o-malo, ae fa'atulafonoina mo uta i tuatusi US. Mo nisi fa'amatalaga, fa'amolemole alu ile: Faʻamatalaga.

Mo na'o tagata nofomau Kalefonia

O lenei oloa e mafai ona tuʻuina atu oe i le antimony oxide, lea e iloa e le Setete o Kalefonia e mafua ai le kanesa, ma toluene, lea e iloa e le Setete o Kalefonia e mafua ai faʻafitauli o le fanau mai poʻo isi faʻalavelave faʻafuaseʻi. Mo nisi fa'amatalaga alu ile www.P65Warnings.ca.gov