Nzira yekuisa sei mudziyo wekurapa?

Kurongeka kwakaringana kwechigadzirwa chako chekurapa ndiyo nhanho yekupinda mumusika, Kuziva mudziyo wako wekurapa kurongedza kwakakosha nekuti:
-Product classification ichaona zvaunofanira kuita usati watengesa chigadzirwa chako zviri pamutemo.
-The classification ichakubatsira iwe kumisa zvinodiwa panguva yekugadzirwa kwechigadzirwa chikamu, kunyanya dhizaini dhizaini.uye maitiro ekupinda mumusika wako.
-The classification chinhu chinokosha pakuona kuti yakawanda sei iwe uchaisa mari kupinda mudziyo wako kumusika zviri pamutemo uye kukupa hutsinye pfungwa kuti zvichatora nguva yakareba sei.
Nekuda kweizvi, ini ndichakupa diki diki nhungamiro kuti unzwisise zviri nani zvekuita uye maitirwo.
Izvi zvinotevera hazvisi gwara rakazara kune zvinotumirwa, asi zvinofanirwa kukupa imwe nhungamiro yekutanga uye gwara rekuti ungazvironga sei.
Pano tichanyora "3 misika mikuru" sepazasi:
1.US Chikafu & Drug Administration, Center for Devices & Radiological Health (FDA CDRH); US FDA inoisa midziyo yekurapa mune imwe yemakirasi matatu - Kirasi I, II, kana III - zvichienderana nenjodzi dzazvo uye kudzora kudzora kunodiwa kupa. vimbiso inonzwisisika yekuchengeteka uye kushanda zvakanaka.semuenzaniso thermometer yedijiti uye infrared thermometer inoiswa mukirasi II.
2.European Commission, sekureva kwepamutemo Journal of European Union Regulation (EU) MDR 2017/745 Annex VIII, zvichibva panguva yekushandiswa, invasive/Non-invasive, inoshanda kana isiri-inoshanda mudziyo, zvishandiso zviri mukirasi I, kirasi IIa, Kirasi IIb uye kirasi III.Semuyenzaniso iyo yedhijitari yekumusoro ruoko yeropa pressure monitor uye wrist style ndiyo Kirasi IIa.
3.China National Medical Products Administration, maererano neMitemo pamusoro pekutarisa uye Kutungamirirwa kwezvishandiso zvekurapa (NO. 739 yeState Council), zvichienderana nenjodzi yemidziyo yekurapa, inoiswa muzvikamu zvitatu, kirasi I, kirasi II uye kirasi III.zvakare China NMPA yakapa Medical device classification directory uye inovandudzwa nguva nenguva.Semuyenzaniso stethoscope kirasi I, thermometer uye blood pressure monitor ikirasi II.
Kune yakadzama nzira yekuisa uye dzimwe nyika nzira yekuisa pasi, isu tinofanirwa kuteerera zvinoenderana nemirairo uye nhungamiro.