Kaha limaske tsa bongaka li ngolisitsoe kapa li laoloa ho latela lisebelisoa tsa bongaka linaheng kapa libakeng tse ngata, bareki ba ka li khetholla ho feta ka tlhaiso-leseling e nepahetseng ea ngoliso le taolo. Se latelang ke mohlala oa Chaena, United States le Europe.
China
Li-mask tsa bongaka ke tsa sehlopha sa bobeli sa lisebelisoa tsa bongaka China, tse ngolisitsoeng le ho laoloa ke lefapha la taolo ea lithethefatsi tsa provense, 'me li ka botsoa ke lisebelisoa tsa bongaka ho botsa nomoro ea phihlello ea sesebelisoa sa bongaka. Sehokelo ke:
http://www.nmpa.gov.cn/WS04/CL2590/.
United States
Lihlahisoa tsa mask tse amohetsoeng ke US FDA li ka botsoa webosaeteng ea eona ea semmuso ho sheba nomoro ea setifikeiti sa ngoliso, sehokelo ke:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Ntle le moo, ho latela LEANO la morao-rao la FDA, hajoale e amoheloa e le Mask of Standards oa China tlasa maemo a itseng, mme sehokelo sa likhoebo tse lumelletsoeng ke:
https://www.fda.gov/media/136663/download.
mokhatlo oa linaha tsa Iropa
Ho romelloa kantle ha limaske tsa bongaka tsa EU ho ka etsoa ka Mekhatlo e Tsebisitsoeng, eo Sehlopha se Tsebisoang se lumelletsoeng ke EU Medical Device Directive 93/42/EEC (MDD) e leng:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13.
Aterese ea lipatlisiso ea 'mele e lumelletsoeng ke EU Medical Device Regulation EU 2017/745 (MDR) ke:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.
Nako ea poso: Apr-17-2022