Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

I know CFDA has allowed the use of overseas medical device trial data for manufacturers registering in China.  However, my understanding is that this  option is available to foreign device manufacturers located outside of China.  What if you are a domestic Chinese manufacturer registering a product in China. What if this Chinese company has a foreign partner with the same device outside of China? Can the Chinese manufacturer leverage clinical trial data from abroad. Let me rephrase:  is the option to use foreign device clinical trial data also available to domestic Chinese manufacturers who wish to leverage data from abroad? Thanks!

As far as i know.
Yes,
you can use the clinical trial data of the device or the device of same kind (if claiming equivalence) conducted outside Chinese territory provided.

• Clinical trials shall comply with related GCP requirements
• The registration applicant shall provide Ethics Committee's comments (if applicable), the clinical study protocol and the clinical study report
• Performance and/or safety of certain products have ethnic differences, the Chinese population data sets can be established for evaluating the safety and/or efficacy of the product in the Chinese population. (i.e. proving the similarities in the study population and Chinese population)

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Kamal Solomon
Gurgaon
India
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Original Message:
Sent: 23-Jan-2019 13:58
From: Anonymous Member
Subject: China - Use of Overseas Clinical Trial Data for medical devices

This message was posted by a user wishing to remain anonymous

Hello,

I know CFDA has allowed the use of overseas medical device trial data for manufacturers registering in China.  However, my understanding is that this  option is available to foreign device manufacturers located outside of China.  What if you are a domestic Chinese manufacturer registering a product in China. What if this Chinese company has a foreign partner with the same device outside of China? Can the Chinese manufacturer leverage clinical trial data from abroad. Let me rephrase:  is the option to use foreign device clinical trial data also available to domestic Chinese manufacturers who wish to leverage data from abroad? Thanks!

Yes, it works for Chinese domestic manufacturer. According to the explanation from China NMPA (previous CFDA) in 2018/07, the guidance also applies to Chinese domestic manufacturer who uses overseas clinical data for product registration in China. By the way, there is no mention about where the manufacturer is. It only talks about oversea clinical data. Hope this can help.

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Colin Lai
Watkinsville GA
United States
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Original Message:
Sent: 23-Jan-2019 13:58
From: Anonymous Member
Subject: China - Use of Overseas Clinical Trial Data for medical devices

This message was posted by a user wishing to remain anonymous

Hello,

I know CFDA has allowed the use of overseas medical device trial data for manufacturers registering in China.  However, my understanding is that this  option is available to foreign device manufacturers located outside of China.  What if you are a domestic Chinese manufacturer registering a product in China. What if this Chinese company has a foreign partner with the same device outside of China? Can the Chinese manufacturer leverage clinical trial data from abroad. Let me rephrase:  is the option to use foreign device clinical trial data also available to domestic Chinese manufacturers who wish to leverage data from abroad? Thanks!