Daidaita Bayani

 Abin da kuke buƙatar sani game da ƙa'idodin phototherapy UVB

Ana sarrafa na'urorin likitanci a Kanada ta Hukumar Kula da Kayayyakin Lafiya ta Kanada (TPD) kuma a cikin Amurka ta Hukumar Abinci da Magunguna (US-FDA). An rarraba na'urorin likitanci zuwa ɗayan azuzuwan 1 zuwa 4, inda Class 1 ke wakiltar mafi ƙarancin haɗari, kuma Class 4 mafi girman haɗari. Duk samfuran Solarc/SolRx UVB phototherapy ana rarraba su azaman “Class 2” a cikin Kanada da Amurka. Lura: US-FDA tana amfani da lambobin roman maimakon lambobi don waɗannan azuzuwan, don haka a cikin Amurka, na'urorin Solarc sune "Class II".

In Canada, Na'urorin Class 2 suna ƙarƙashin iko da yawa, gami da: - Biyayya ga Dokokin Na'urar Kiwon Lafiya ta Kanada (CMDR) - Izinin kasuwa ta hanyar lasisin na'urar farko da na shekara - Tilas ISO-13488 ko ISO-13485 Tsarin Inganci da kuma alaƙar shekara ta 3rd. tantancewar jam’iyya, da Bayar da Rahoton Matsalolin Tilas. Ana iya samun lissafin lasisin na'urar don Solarc Systems akan gidan yanar gizon Lissafin Lasisin Na'urorin Likitan Lafiya na Kanada a: www.mdall.ca. Danna "Binciken Lasisi mai Aiki", kuma amfani da "Sunan Kamfanin" (Solarc). A madadin, je zuwa shafin gida na Na'urar Likitan Lafiya ta Kanada.

Note1: A Yuli-21-2008, Solarc's uku Health Canada Medical Na'urar lasisi lasisi (12783,62700,69833) aka hade zuwa daya lasisi (12783). “Batun Farko na Farko” na duk na'urori ban da jerin 1000-21 yanzu suna bayyana kamar Yuli-2008-16; ko da yake an fara ba wa waɗannan na'urori lasisi a watan Yuni-2003-62700 don 500 (02-Series) da Dec-2005-69833 don 100 (Series 1000). Hakanan lura cewa jerin 1993-An fara ba da lasisi a cikin Feb-157340 ta "Kiwon Lafiya da Jin Dadin Kanada" akan Samun #1998, kafin sabon Dokokin Na'urar Kiwon Lafiya ta Kanada na Mayu XNUMX.

Note2: Duk na'urorin UVB na Solarc Systems (UVB-Narrowband da UVB-Broadband) sun sami amincewar Lafiya ta Kanada don ƙara "Rashin Vitamin D" zuwa "Alamomin Amfani" (yanayin kiwon lafiya wanda za'a iya tallata shi bisa doka) akan Yuli 21, 2008 gyara na Solarc's kowane Lasisin Na'urar Kanada na Lafiya #12783.

Note3: A ranar 05 ga Janairu, 2011, Solarc ta sami amincewar Lafiyar Kanada don ƙara dangin na'urar mu ta 4, jerin E-Series, zuwa lasisin na'urar mu ta Kanada #12783. Lasisin Na'urar Likitan Lafiya ta Kanada #12783 ana nuna shi a kasan wannan shafin yanar gizon.

a cikin Amurka, Na'urorin Class II (Class 2) suma suna ƙarƙashin iko da yawa, gami da:

- Yarda da sassan da suka dace na Code of Federal Regulations (CFR)

- Izinin kasuwa ta hanyar aikace-aikacen farko na 510 (k) da kuma yanke hukunci mai mahimmanci

- Gabatar da rahotannin Farko & Canjin samfur zuwa Cibiyar Na'urori da Lafiyar Radiyo (CDRH)

- Jerin Na'urar (Daya ga lambar samfur)

– Tilas “Kyakkyawan Ayyukan Kirkira” (GMP) Tsarin Ingancin

– Rahoton Matsala na Tilas

US-FDA ba ta ba da izinin yin amfani da tallace-tallace na 510 (k) ko wasu bayanan tsari ba. Koyaya, ana iya samun wannan bayanin ta hanyar doka ta hanyar doka US-FDA/CDRH gidan yanar gizo. A gefen dama, gungura ƙasa zuwa Kayan aiki & Albarkatu> Databases na Na'urar Likita, inda zaku iya bincika Faɗin Kasuwancin 510(k)'s da Lissafin Na'ura. Bincika ta amfani da "Sunan Mai Bukata" (Solarc) ko "Mai shi/Sunan Mai Aiki" (Solarc).

Yi amfani da hanyoyin haɗin yanar gizo masu zuwa zuwa binciken bayanan bayanan FDA:

510 (k) Binciken Database

Binciken Bayanan Bayanai na Na'ura

Note1: (mai amfani ga Amurka kawai)

A cikin 2011 da kuma yin amfani da tsarin 510 (k) na FDA, Solarc ya gaza a ƙoƙarinsa na samun "Rashin Vitamin D" da aka ƙara zuwa "Alamomin Amfani" saboda babu wani na'urar "predicate" (wanda ya riga ya kasance) da ya wanzu, kuma don samun amincewa. a maimakon haka zai buƙaci aikace-aikacen Amincewa da Kasuwar Kasuwa mai tsananin tsada mai tsadar gaske "PMA". A cikin Amurka, Solarc shine don haka ba an ba da izini don haɓaka na'urorin don "Rashin Vitamin D"; kuma a maimakon haka kawai don yarda da "Alamomin Amfani" na psoriasis, vitiligo, da eczema. A cikin wannan mahallin, "Rashin bitamin D" ana ɗaukarsa a matsayin amfani da "kashe-lakabin", amma duk da haka, likita na iya buƙatar bayani game da amfani da alamar, kuma an ba da izinin likita bisa doka don rubuta takardar sayan magani ga majiyyaci. don samun samfurin. An san wannan ra'ayi a matsayin "aiki na magani", wanda ke nufin cewa likita na iya rubutawa ko gudanar da duk wani samfurin da aka sayar da shi bisa doka don kowane amfani da lakabin da suke ganin yana da amfani ga majiyyaci.

Rubutun Likita

Rubutun likitancin zaɓi ne don jigilar kaya zuwa adiresoshin Kanada da na ƙasashen waje, amma wajibi ne don jigilar kaya zuwa adiresoshin Amurka. Don ƙarin bayani, da fatan za a je: prescriptions.

Don Mazauna California Kawai

Wannan samfurin zai iya fallasa ku zuwa ga antimony oxide, wanda jihar California ta san yana haifar da ciwon daji, da kuma toluene, wanda jihar California ta sani don haifar da lahani na haihuwa ko wasu lahani na haihuwa. Don ƙarin bayani jeka www.P65Warnings.ca.gov

Lasin Na'urar Solarc Kanada 12783 Canja Lambar Wasika 2017 08 21 shafi 001 Solarc Systems FDA