Medical Device Operation Permit Chikumbiro muChina

Kune makirasi matatu emidziyo yekurapa. YeKirasi I, kambani inofanirwa kunge iine hukama hwebhizinesi chiyero; seKirasi II, kambani yaizoda kunyorera rekodhi rekodhi; uye yeKirasi III, kambani inofanirwa kunyorera mvumo yekushanda.

1. Ita kuti kambani inyoreswe nehuwandu hwebhizimisi hwe "kutengesa kweClass II mishonga yezvokurapa".

2. Mushandi mumwe chete ane dhigirii rekurapa kana remishonga kana pamusoro (anoenderera mberi, makopi emarezinesi, uye humbowo hwedzidzo).

3. Imba yekuchengetera yenguva dzose ine nharaunda inopfuura 45㎡ uye yakazara nzvimbo inopfuura zana㎡.

4. Kopi yechitupa cheimba uye chibvumirano chepakutanga chekurenda (chakarenda muzita rekambani).

5. Mutengesi anofanira kupa: kopi yebhizimisi rezinesi, chitupa chekunyoresa chigadzirwa, chitupa chehutano, tsamba yemvumo (yakadhindwa nechisimbiso chepamutemo).

6. Rezinesi rebhizinesi rine chisimbiso chepamutemo, nezvimwe.

Isu tinofanirwa kutarisa chitupa chekunyoresa cheKirasi III mishonga yemidziyo yekurapa kutanga, kuti tipe ruzivo rwakadzama rwereferensi yako.

1. Ita kuti kambani inyoreswe nehukuru hwebhizinesi "kutengesa kweClass III michina yekurapa".

2. Vashandi: Zvinzvimbo zve9 zvinomisikidzwa muClass III michina yekurapa inoshanda mabhizinesi, kusanganisira mumiriri wepamutemo, mutungamiriri webhizinesi, maneja wemhando, maneja wemhando yeInstitute manejimendi, inspector, kutengesa, mushure mekutengesa, warehouse management, uye komputa. management. Zvinzvimbo izvi zvinogona kuitwa panguva imwe chete, asi vanosvika vatatu vashandi, vaine magwaro akadai seyekutanga uye kopi yezvitupa zvekuzivikanwa uye zvitupa zvedzidzo. Zvichakadaro, maneja wemhando anofanirwa kunge aine makore matatu ehunyanzvi hwekutungamira uye zvine chekuita nekurapa mune zvedzidzo.

Kana iyo kambani yaizoshanda in vitro diagnostic reagent, implants uye inopindira mishonga yekurapa, yekubata lens kana zvimwe zvakakosha zvekurapa, pane zvimwe zvinodiwa kune vashandi. Ndapota taura nenyanzvi dzedu mazano kuti uwane mamwe mashoko.

2. Medical device management software (inoda invoice yekutenga).

3. Kopi yechitupa cheimba uye chibvumirano chepakutanga chekurenda (chakarenda muzita rekambani).

4. Mutengesi anofanira kupa: makopi echitupa chekunyoresa chepakutanga uye akadzokorora uye zvitupa zvine chekuita nemupi (rezinesi rebhizinesi, gwaro rekunyoresa mudziyo wekurapa), rakadhindwa nechisimbiso chepamutemo (kupa mugadziri kana chitupa chekunyoresa mumiririri).

5. Enterprise management system, mushure mekutengesa sevhisi system, kudzidziswa kwevashandi.

6. Rezinesi rebhizinesi rine chisimbiso chepamutemo, nezvimwe.

Isu tinokwanisa kupa kero yekunyoresa kune vatengi vedu vangade kuita bhizinesi rekushandisa zvekurapa asi vasati vatora hofisi. Neanoda kusvika makore makumi maviri ruzivo rweindasitiri uye zviwanikwa zvakawanda, isu tichakubatsira iwe kuti uende nenzira kwayo mushe.