CFDA updated five regulations to be effective from October 1, 2014

rangani_rj

Involved In Discussions
#1
Hi all,

As a part of early announcement to implement revised "Medical Devices Regulations" (which is effective from June 1, 2014), CFDA has finalised five regulations (General Order No. 4,5,6,7,8) to be effective from October 1, 2014.

Announcement link
http://www.sda.gov.cn/WS01/CL0051/103755.html

Order No. 4 - Medical Device Registration
Order No. 5 - IVD Registration
Order No. 6 - Medical Device specification and labeling regulations
Order No. 7 - Production Supervision and Administration of Medical Devices
Order No. 8 - Medical Device Regulatory Measures

PDFs in English are attached here. Officially published in Chinese, I have translated them to English using Google translator.

Cheers,
 

Attachments

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pittmatj

Involved In Discussions
#3
Thanks.

How long does it take for CFDA to provide the "official" English version of their documents? I've heard it's approximately 3 months.
 
M

missjenny

#4
Thank you for the English version! This is much appreciated. It is so frustrating that a competent authority of that size and influence does not provide official English versions of their regulations right away. It would be great if you or anybody else could provide more accurate version soon.
 
L

llz123

#5
Does anybody know when the list if devices class II and III, exempted from clinical trials will be published?
 
G

Gargi

#6
Hi all,

As a part of early announcement to implement revised "Medical Devices Regulations" (which is effective from June 1, 2014), CFDA has finalised five regulations (General Order No. 4,5,6,7,8) to be effective from October 1, 2014.

Announcement link
http://www.sda.gov.cn/WS01/CL0051/103755.html

Order No. 4 - Medical Device Registration
Order No. 5 - IVD Registration
Order No. 6 - Medical Device specification and labeling regulations
Order No. 7 - Production Supervision and Administration of Medical Devices
Order No. 8 - Medical Device Regulatory Measures

PDFs in English are attached here. Officially published in Chinese, I have translated them to English using Google translator.

Cheers,

Hi :bigwave:,

Do these changes are with respect to Class I device only?
Please confirm.
Thanks in advance:thanx:
 
S

ShareKing

#8
Does anybody know when the list if devices class II and III, exempted from clinical trials will be published?
The medical device class III exempted from clinical trial was published on 21th August. The list includes 79 different products

www.sda.gov.cn/WS01/CL0087/105225.html

The list of device class III, that needs clinical trial published, was published five days later

www.sda.gov.cn/WS01/CL0087/105374.html

The products that fells in-between is still not clear. It is assumed that more detailed regulation will be published.

As a new-comer, I can not post links in my reply. Please replace the "3w" with "www" and you will see the chinese webpage
 
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