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 Zomwe muyenera kudziwa zokhudza malamulo a UVB phototherapy

Zipangizo zamankhwala zimayendetsedwa ku Canada ndi Health Canada Therapeutic Products Directorate (TPD) komanso ku USA ndi Food & Drug Administration (US-FDA). Zipangizo zamankhwala zimayikidwa m'gulu limodzi mwa Makalasi 1 mpaka 4, pomwe Gulu 1 limayimira chiwopsezo chochepa kwambiri, ndipo Gulu 4 ndilomwe lili pachiwopsezo chachikulu. Zogulitsa zonse za Solarc/SolRx UVB phototherapy zimatchedwa "Class 2" ku Canada ndi USA. Zindikirani: US-FDA imagwiritsa ntchito manambala achiroma m'malo mwa manambala a makalasiwa, kotero ku USA, zida za Solarc ndi "Class II".

In Canada, Zida Zam'kalasi 2 zimayang'aniridwa ndi maulamuliro ambiri, kuphatikiza: - Kutsata Malamulo a Chida Chachipatala ku Canada (CMDR) - Chilolezo chamsika pogwiritsa ntchito chilolezo choyambirira komanso chapachaka - Yovomerezeka ISO-13488 kapena ISO-13485 Quality System ndi 3rd yapachaka yogwirizana nayo kuwunika kwa chipani, ndi Kufotokozera Mavuto Oyenera. Mindandanda yamalayisensi ya chipangizo cha Solarc Systems ikupezeka patsamba la Health Canada's Medical Devices License Listing pa: www.mdall.ca. Dinani "Kusaka License Yogwira", ndikugwiritsa ntchito "Dzina la Kampani" (Solarc). Kapenanso, pitani patsamba loyambira la Health Canada's Medical Device.

Zindikirani1: Pa July-21-2008, Malayisensi atatu a Solarc a Health Canada Medical Device (12783,62700,69833) adaphatikizidwa kukhala chilolezo chimodzi (12783). "Tsiku Loyamba Lotulutsa" pazida zonse kupatula 1000-Series tsopano zikuwoneka ngati July-21-2008; ngakhale zida izi zidapatsidwa chilolezo koyamba pa June-16-2003 pa 62700 (500-Series) ndi Dec-02-2005 pa 69833 (100-Series). Dziwaninso kuti 1000‑Series idapatsidwa chilolezo koyamba mu Feb-1993 ndi "Health and Welfare Canada" pa Accession #157340, Malamulo atsopano a Zamankhwala aku Canada a Meyi 1998 asanachitike.

Zindikirani2: Zida zonse za Solarc Systems 'UVB (UVB-Narrowband ndi UVB-Broadband) zinalandira chilolezo cha Health Canada kuti chiwonjezere "Kuchepa kwa Vitamini D" ku "Zizindikiro Zogwiritsira Ntchito" (zaumoyo zomwe zingalengezedwe mwalamulo) pa July 21, 2008 kusintha kwa Solarc's pa Health Canada Device License #12783.

Zindikirani3: Pa Januware 05, 2011, Solarc idalandira chilolezo cha Health Canada kuti tiwonjezere banja lathu lachida 4, E-Series, ku License yathu ya Chida cha Health Canada #12783. Solarc's Health Canada Medical Device License #12783 ikuwonetsedwa pansi pa tsamba ili.

Mu USA, Zida za Class II (Class 2) zilinso ndi maulamuliro ambiri, kuphatikizapo:

- Kutsata magawo omwe akugwiritsidwa ntchito mu Code of Federal Regulations (CFR)

- Chilolezo chamsika pogwiritsa ntchito 510 (k) kugwiritsa ntchito koyambirira ndi chigamulo cha kufanana kwakukulu

- Kutumiza kwa Malipoti Oyambirira & Kusintha Kwazinthu ku Center for Devices and Radiological Health (CDRH)

- Mndandanda wa Chipangizo (Chimodzi pazogulitsa)

- Njira Yabwino Yopangira "Zabwino Zopanga" (GMP).

- Kufotokozera Vuto Loyenera

US-FDA salola kugwiritsa ntchito malonda a 510(k) kapena zambiri zamalamulo. Komabe, izi zitha kupezedwa mwalamulo kuchokera ku Webusaiti ya US-FDA/CDRH. Kumanja, yendani pansi ku Zida & Zothandizira> Zosunga Zamankhwala Zamankhwala, komwe mungafufuze Zidziwitso za Premarket 510(k) ndi Mndandanda wa Zida. Sakani pogwiritsa ntchito "Dzina Lofunsira" (Solarc) kapena "Dzina la Mwini / Wothandizira" (Solarc).

Gwiritsani ntchito maulalo otsatirawa pakusaka kwa database ya FDA:

510(k) Kusaka Kwankhokwe

Kusaka Kwa Database Yazida

Zindikirani1: (imagwira ntchito ku USA kokha)

Mu 2011 ndikugwiritsa ntchito njira ya FDA's 510(k), Solarc inalephera kuyesa "Kuchepa kwa Vitamini D" kuwonjezeredwa ku "Zizindikiro Zogwiritsira Ntchito" chifukwa palibe chipangizo chofananira cha "predicate" (kale) chomwe chinalipo, ndi kupeza chilolezo. m'malo mwake zikanafuna ntchito yotsika mtengo kwambiri ya Premarket Approval "PMA". Ku USA, Solarc ndi choncho osati amaloledwa kulimbikitsa zipangizo za "Vitamini D Kuperewera"; ndipo m'malo mwazovomerezeka "Zizindikiro Zogwiritsira Ntchito" za psoriasis, vitiligo, ndi eczema. M'nkhaniyi, "Kuchepa kwa Vitamini D" kumaonedwa kuti ndi ntchito "yopanda label", koma mosasamala kanthu, dokotala akhoza kupemphabe zambiri zokhudzana ndi kugwiritsa ntchito mankhwala osokoneza bongo, ndipo dokotala amaloledwa mwalamulo kulemba mankhwala kwa wodwalayo. kupeza mankhwala. Lingaliro limeneli limadziwika kuti "kachitidwe ka mankhwala", zomwe zikutanthauza kuti dokotala akhoza kulembera kapena kupereka mankhwala aliwonse ogulitsidwa mwalamulo pa ntchito iliyonse yopanda malemba yomwe amawona kuti ndi yabwino kwa wodwalayo.

Malangizo a Dokotala

Zolemba za adokotala ndizosasankha kuti zitumizidwe ku maadiresi aku Canada ndi akunja, koma ndizovomerezeka kuti zitumizidwe ku ma adilesi aku US. Kuti mudziwe zambiri, chonde pitani ku: Malemba.

Kwa okhala ku California kokha

Mankhwalawa amatha kukupatsirani antimony oxide, yomwe imadziwika ku State of California kuti imayambitsa khansa, ndi toluene, yomwe imadziwika ku State of California kuti imayambitsa zilema za kubala kapena kuvulaza kwina. Kuti mudziwe zambiri pitani ku www.P65Warnings.ca.gov

Solarc Health Canada Chipangizo License 12783 Change Post Code 2017 08 21 tsamba 001 Solarc Systems FDA