Ozi nchịkwa

 Ihe ị kwesịrị ịma gbasara ụkpụrụ UVB phototherapy

A na-ahazi ngwaọrụ ahụike na Canada site na Health Canada's Therapeutic Products Directorate (TPD) yana na USA site na nchịkwa nri na ọgwụ ọjọọ (US-FDA). A na-ekewa ngwaọrụ ahụike n'ime otu klas 1 ruo 4, ebe klaasị 1 na-anọchite anya ihe ize ndụ kacha ala, yana Klas 4 bụ ihe egwu kachasị elu. All Solarc/SolRx UVB phototherapy ngwaahịa bụ nkewa dị ka "Klas 2" na Canada na USA. Mara: US-FDA na-eji ọnụọgụ roman kama ọnụọgụgụ maka klaasị ndị a, yabụ na USA, ngwaọrụ Solarc bụ “Klas II”.

In Canada, Ngwa klaasị 2 nọ n'okpuru ọtụtụ njikwa, gụnyere: - Nrube isi na iwu Canadian Medical Device Regulations (CMDR) - ikike ahịa site na ikikere ngwaọrụ mbụ na nke afọ - Amanyere ISO-13488 ma ọ bụ ISO-13485 Ogo Sistemu yana ihe metụtara 3rd kwa afọ. nyocha ndị otu, na mkpesa nsogbu nke amanyere iwu. Enwere ike ịchọta ndepụta ikike ngwaọrụ maka Sistemụ Solarc na webụsaịtị Ndepụta ikike ngwaọrụ ahụike ahụike Canada na: www.mdall.ca. Pịa “Chọọ ikike ọrụ” wee jiri “Aha ụlọ ọrụ” (Solarc). N'aka nke ọzọ, gaa na ibe ụlọ ngwaọrụ ahụike Health Canada.

Note1: Na Julaị-21-2008, akwụkwọ ikike ngwaọrụ ahụike ahụike nke Solarc atọ (12783,62700,69833) jikọtara na otu ikike (12783). "Ụbọchị mbipụta nke mbụ" maka ngwaọrụ niile ma e wezụga usoro 1000-egosi ugbu a dị ka Julaị-21-2008; Agbanyeghị na enyere ikike izizi ngwaọrụ ndị a na June-16-2003 maka 62700 (500-Series) na Dec-02-2005 maka 69833 (100-Series). Rịba ama na 1000-Series bụ nke mbụ nyere ikike na Feb-1993 site na "Health and Welfare Canada" na ntinye #157340, tupu iwu ọhụrụ ngwaọrụ ahụike Canada nke Mee 1998.

Note2: All Solarc Systems'UVB ngwaọrụ (UVB-Narrowband na UVB-Broadband) nwetara nkwado Health Canada iji tinye "Enweghị vitamin D" na "Ngosipụta ojiji" (ọnọdụ ahụike nke enwere ike ịkpọsa n'ụzọ iwu kwadoro) na July 21, 2008 mmezi nke Solarc's kwa Health Canada ikike ikike #12783.

Note3: Na Jenụarị 05, 2011, Solarc nwetara nkwado Health Canada iji tinye ezinụlọ ngwaọrụ anyị nke anọ, usoro E-Series, na ikike ngwaọrụ Canada Health Canada dị #4. Egosiri ikike ngwaọrụ ahụike ahụike nke Solarc Canada #12783 na ala nke ibe weebụ a.

na USA, Klas II (Klas 2) ngwaọrụ nwekwara ọtụtụ njikwa, gụnyere:

- Nrube isi na ngalaba ndị dị na Code of Federal Regulations (CFR)

- Ikike ahịa site na ngwa 510 (k) izizi yana ikpebi oke nhata

- Nnyefe nke mbido & Mgbanwe ngwaahịa na Center for Devices and Radiological Health (CDRH)

- Ndepụta ngwaọrụ (otu koodu ngwaahịa ọ bụla)

- Amanyere iwu "Ezigbo Mmepụta Mmepụta" (GMP) Sistemu Ogo

- Mkpesa nsogbu amanyere iwu

US-FDA anaghị anabata iji 510 (k) ahịa ma ọ bụ ozi nchịkwa ndị ọzọ. Agbanyeghị, enwere ike nweta ozi a n'ụzọ iwu site na iwu Webụsaịtị US-FDA/CDRH. N'akụkụ aka nri, pịgharịa gaa na Ngwa & Akụrụngwa> Databases Device Medical, ebe ị nwere ike ịchọ ọkwa Premarket 510(k)'s na Ndepụta ngwaọrụ. Chọọ site na iji “Aha Onye anamachọihe” (Solarc) ma ọ bụ “Aha Onye nwe/Aha Ọrụ” (Solarc).

Jiri njikọ ndị a na ọchụchọ nchekwa data FDA:

510 (k) Ọchụchọ nchekwa data

Ọchụchọ nchekwa data Ndepụta ngwaọrụ

Note1: (Ọdabara na USA naanị)

N'afọ 2011 na iji usoro 510 (k) FDA, Solarc dara na mbọ ya iji nweta "Enweghị vitamin D" agbakwunyere na "Ngosipụta maka ojiji" n'ihi na ọ dịghị ngwaọrụ "predicate" (bụbu adịbu) yiri nke dị adị, na iji nweta nkwado. kama ọ ga-achọrịrị ngwa nnabata “PMA” Premarket na-amachibidoro oke ọnụ. Na United States, Solarc bụ ya mere ọ bụghị ekwe ka ịkwalite ngwaọrụ maka "Enweghị vitamin D"; na kama naanị maka “Ngosipụta maka ojiji” nke psoriasis, vitiligo, na eczema akwadoro. N'okwu a, a na-ewere "Enweghị vitamin D" dị ka ihe eji eme ihe "na-apụ apụ", ma n'agbanyeghị, dọkịta ka nwere ike ịrịọ maka ozi gbasara iji akara ngosi, na iwu kwadoro dọkịta ka ọ dee ndenye ọgwụ maka onye ọrịa. iji nweta ngwaahịa. A maara echiche a dị ka "omume ọgwụ", nke pụtara na dọkịta nwere ike ịdepụta ma ọ bụ nye ngwaahịa ọ bụla a na-ere ahịa n'ụzọ iwu maka iji akara ọ bụla nke ha chere na ọ dị mma maka onye ọrịa.

Ndenye ndị dọkịta

Ndenye ndenye ọgwụ bụ nhọrọ maka mbupu gaa na adreesị Canada na mba ụwa, mana ọ bụ iwu maka ibuga na adreesị US. Maka ozi ndị ọzọ, biko gaa na: Ihe odide.

Maka ndị bi na California naanị

Ngwaahịa a nwere ike ikpughe gị na antimony oxide, nke steeti California mara na ọ na-ebute ọrịa kansa, yana toluene, nke steeti California mara na ọ na-ebute ntụpọ ọmụmụ ma ọ bụ mmebi ọmụmụ ọzọ. Maka ozi ndị ọzọ gaa na www.P65Warnings.ca.gov

Akwụkwọ ikike ngwaọrụ nke Solarc Health Canada 12783 Gbanwee koodu nzi ozi 2017 08 21 ibe 001 Solarc Systems FDA