Ungabubheka kanjani ubuqiniso bemaski yezokwelapha

Njengoba imaski yezokwelapha ibhalisiwe noma ilawulwa ngokuya ngemishini yezokwelapha emazweni amaningi noma ezifundeni, abathengi bangaqhubeka bewahlukanisa ngokubhalisa nokulawula okufanelekile. Okulandelayo isibonelo se-China, i-United States ne-Europe.

China
Imaski yezokwelapha ingeyesigaba sesibili semishini yezokwelapha e-China, ebhaliswe futhi elawulwa umnyango olawula izidakamizwa wesifundazwe, futhi ingabuzwa ngemishini yezokwelapha ukuze ibuze inombolo yokufinyelela idivayisi yezokwelapha. Isixhumanisi sithi:

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

I-united states
Imikhiqizo yemaski egunyazwe yi-US FDA ingabuzwa ngewebhusayithi yayo esemthethweni ukuze kubhekwe inombolo yesitifiketi sokubhaliswa, isixhumanisi sithi:

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

Ngaphezu kwalokho, ngokweNQUBOMGOMO yakamuva ye-FDA, okwamanje yaziwa njengeMask of Chinese Standards ngaphansi kwezimo ezithile, futhi isixhumanisi samabhizinisi ayo agunyaziwe yilesi:

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

iyuniyani yase-Europe
Ukuthunyelwa kwamanye amazwe imaski yezokwelapha ye-EU kungenziwa ngeMigwamanda Ezazisiwe, lapho Umkhandlu Owazisiwe ogunyazwe i-EU Medical Device Directive 93/42/EEC (MDD) ithi:

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

Ikheli lombuzo womzimba ozisiwe eligunyazwe i-EU Medical Device Regulation EU 2017/745 (MDR) lithi:

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