Indlela yokujonga ukunyaniseka kweemaski zonyango

Ekubeni iimaski zonyango zibhalisiwe okanye zilawulwa ngokwezixhobo zonyango kumazwe amaninzi okanye kwimimandla, abathengi banokuqhubeka bezahlula ngobhaliso olufanelekileyo kunye nolwazi lokulawula. Oku kulandelayo ngumzekelo weTshayina, iUnited States kunye neYurophu.

eTshayina
Iimaski zonyango zezodidi lwesibini lwezixhobo zonyango e-China, ezibhalisiweyo nezilawulwa lisebe lephondo elilawula amachiza, kwaye zinokubuzwa zizixhobo zonyango ukubuza inombolo yofikelelo kwisixhobo sonyango. Ikhonkco yile:

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

Amazwe Amanyene
Iimveliso zemaski ezivunyiweyo yi-US FDA zinokubuzwa kwiwebhusayithi yayo esemthethweni ukujonga inombolo yesatifikethi sobhaliso, ikhonkco yile:

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

Ukongeza, ngokwePOLICY yamva nje ye-FDA, okwangoku yamkelwa njengeMask yeMigangatho yaseTshayina phantsi kweemeko ezithile, kwaye ikhonkco lamashishini agunyazisiweyo yile:

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

udibano lwaseyurophu
Ukuthunyelwa ngaphandle kweemaski zonyango ze-EU kunokwenziwa ngamaqumrhu agunyazisiweyo, apho iZiko elaziswayo eligunyaziswe yi-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.

Idilesi yombuzo webhodi eyazisiweyo egunyaziswe yi-EU Medical Device Regulation EU 2017/745 (MDR) yile:

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