Otu esi elele izi ezi ihe mkpuchi ahụike

Ebe ọ bụ na edebanye aha ma ọ bụ na-achịkwa ihe mkpuchi ahụike dịka ngwaọrụ ahụike siri dị n'ọtụtụ mba ma ọ bụ mpaghara, ndị na-azụ ahịa nwere ike ịmatakwu ha site na ndebanye aha na ozi njikwa dị mkpa. Nke a bụ ihe atụ nke China, United States na Europe.

China
Ihe mkpuchi ahụike bụ nke klaasị nke abụọ nke ngwaọrụ ahụike na China, nke ngalaba na-ahụ maka ọgwụ mpaghara debanyere aha na jikwaa ya, yana ngwaọrụ ahụike nwere ike jụọ ya ka ọ jụọ nọmba ịnweta ngwaọrụ ahụike. Njikọ ahụ bụ:

http://www.nmpa.gov.cn/WS04/CL2590/

United States
Enwere ike jụọ ngwaahịa nkpuchi nke US FDA kwadoro site na webụsaịtị ya iji lelee nọmba akwụkwọ ndebanye aha, njikọ a bụ:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Na mgbakwunye, dịka iwu kachasị ọhụrụ nke FDA si dị, a na-amata ya ugbu a dị ka ihe nkpuchi nke ụkpụrụ China n'okpuru ọnọdụ ụfọdụ, yana njikọ nke ụlọ ọrụ ikike ya bụ:

https://www.fda.gov/media/136663/download.

European Union
Enwere ike ibupụ ihe mkpuchi ahụike EU site na ụlọ ọrụ amaara ikike, nke ụlọ ọrụ amaara ọkwa nke EU Medical Device Directive 93/42/EEC (MDD) nyere ikike bụ:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13.

Adreesị ajụjụ ahụ amaara ọkwa nke EU Medical Device Regulation EU 2017/745 (MDR) nyere ikike bụ:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.