Where to get started on Medical Device Regulations for China

[Tonyfang]

In Reply to Parent Post by ramkannan13

Dear all,

Can someone help me out , where to get started on Medical device regulation for China.

1) The Classification
2) Registration
3) Submission of Technical file.

In the meantime ..Im also doing my homework in searching through the SFDA website, but if someone can help me with some material I would greatly apprecaite it.

You can find in the SFDA's website

[v9991]

here's few references ...

Provisions for Medical Device Classification
http://eng.sfda.gov.cn/WS03/CL0768/61643.html

Regulations for the Supervision and Administration of Medical Devices
http://eng.sfda.gov.cn/WS03/CL0767/61641.html

Provisions for Clinical Trials of Medical Devices
http://eng.sfda.gov.cn/WS03/CL0768/61644.html

Initial registration of import products
http://eng.sfda.gov.cn/WS03/CL0770/61661.html

Re-registration of import products
http://eng.sfda.gov.cn/WS03/CL0770/61660.html

[paulag]

Dear all,

just trying to find out which class of medical device a single use lancing device would be in China, and I just can't find it. Is it "other contacting passive device" which would be AA10 1 1? Or is there more to classification than this "Criteria" document I attached?

For FDA it would be class 1, Code FMK, in Europe IIa, I suppose, but China?!?!

Need help!

[Tonyfang]

IN Chian is II

[paulag]

Hello Tony,

could you please tell me where you found class II?

I have been told that the lancing devices are class I (category 6841, 4) and the lancets themselves in category 6815, which would be class III!!! It can't be right, can it? Why should a simple blood lancet be in the highest risk category?

Help needed...

[Tonyfang]

6841 is medical tests and basic equipment & apparatus it include Vacuum blood collection tubes , blood collection needle , laser blood machine ,there are class II

[paulag]

so much!