To change the manufacturing site of imported overseas IVD reagents, besides the documents (application form, home country approval of the change, statement/description about the change etc.) needed for all permission item changes, NMPA also require the applicant to submit the following documents (CFDA Circular [2014] NO. 44):
- The quality system assessment report of the manufacturing site change (if applicable)
- Documents which can prove that the new manufacturing site can meet the Quality Management System requirements of the country (region) where the site is located or the documents which can prove that the new manufacturing site has passed the quality management system certification.
- The analytical performance study data using the products produced at the new manufacturing site.
- Updated IFU and label artwork.
NMPA (CFDA) does not indicate specific requirements on the analytical performance evaluation data, however, all verification and validation documents are used as supportive documents to demonstrate the equivalency between the products before and after the change of manufacturing site. The analytical characteristics in registered Product Technical Requirements are recommended to be tested and verified.
Moreover, the analytical performance evaluation plan/protocol should be able to support the information provided in the "statement/description about the change", which includes
- Reason and purpose for change
- Technical analysis of the possible impact of change on the performance of the product
- Product risk analysis data relating to product change.
Please be noted that documents requirements listed above are not applicable for transferring the manufacturing site of products with Imported Medical Device Certificate to local enterprise in China. A new guidance came out recently covering this. For more information, please feel free to contact me.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------
Original Message:
Sent: 19-Oct-2020 13:52
From: Matheus Falceta
Subject: IVD Manufacturing Site Change in China
Good Afternoon,
Our experience with an address change with China was a nightmare.
In 2017, we moved all of our manufacturing processes into a new building down the street from our previous address. At that time, we were required to perform a full re-evaluation of the product, including Real Time Stability evaluation.
Thank you,
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Matheus Falceta
Design Assurance Specialist
Norman OK
United States
Original Message:
Sent: 16-Oct-2020 08:03
From: Anonymous Member
Subject: IVD Manufacturing Site Change in China
This message was posted by a user wishing to remain anonymous
Dear Colleagues,
can somebody please share her / his experience with manufacturing site changes submitted to the Chinese NMPA for IVDs?
More specifically, I am referring to the situation in which the manufacturing site is changed for a class II or III IVD, without affecting the legal manufacturer (which remains unchanged) and without making any significant change to the product manufacturing process / specs / design. Suppose the new facility is also producing IVDs for China.
What kind of evidences did NMPA want to receive? Did the Authority request a full analytical re-evaluation of the product, or was a risk-based approach to product verification accepted?
Thank you in advance for your feedback!