rangani_rj
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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,
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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IVD Registration Regulation.pdf127.9 KB · Views: 185
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Medical Device Registration.pdf231 KB · Views: 279
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Medical Device Regulatory Measures.pdf158.8 KB · Views: 243
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Medical Device specification and labeling regulations.pdf122.2 KB · Views: 326
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Production Supervision and Administration of Medical Devices.pdf175.7 KB · Views: 302