SBS - The best value in QMS software

Amending CFDA Registration for changing site of shipment

max.polix

Involved In Discussions
#1
Does anybody know what process is to be followed to amend a registration with CFDA (hopefully not a new registration) for a change of the site where the products are configured (Chinese user manual in the box, software liceses installed, Chinese lebel on the units and the boxes) and shipped to China?

The manufacturing process is not at all impacted by the change. Let's say this is the warehouse where production put the manufactured units and logistics ship to customers.

Thanks.
Max
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B Amending Registration with CFDA due to Change in Site of Manufacture China Medical Device Regulations 3
M Informational Commission Regulation (EU) 2019/319 of 6 February 2019 amending previous regulations as regards health certification at import into the Union concerni Medical Device and FDA Regulations and Standards News 0
bio_subbu EU Publishes New DIRECTIVE (EU) 2017/2102 AMENDING 2011/65/EU ON ROHS-2 REACH and RoHS Conversations 0
H Amending Test and Computation PMA (Parts Manufacturing Approval) Federal Aviation Administration (FAA) Standards and Requirements 2
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
J Change management with CFDA approved devices China Medical Device Regulations 1
shimonv Submissions to NMPA (formerly CFDA) Paid Consulting, Training and Services 0
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
E RF Energy Treatment Devices for CFDA Registration China Medical Device Regulations 1
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
R CFDA submission fees as of May 2015 China Medical Device Regulations 4
Y Is CFDA registration required if the full system is registered by our distributors? China Medical Device Regulations 2
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
P Is an English version of CFDA YY0664-2008 available? China Medical Device Regulations 3
J CFDA issues Guiding Opinions on Enhancing the Construction of Food and Drug Inspectio China Medical Device Regulations 1
A CFDA - List of Class II Medical Devices exempt from Clinical Trials China Medical Device Regulations 2
R CFDA updated five regulations to be effective from October 1, 2014 China Medical Device Regulations 16
C CFDA announced 120 new Medical Device Standards - July 2014 China Medical Device Regulations 0
C CFDA MD regulation_20140331 - Comes into effect June 01, 2014 China Medical Device Regulations 33
pittmatj CFDA Requests Biocompatibility Evaluation for Raw Materials ISO 13485:2016 - Medical Device Quality Management Systems 6
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
T CFDA Simplifies Medical Device Re-Registration Process China Medical Device Regulations 1
Q SFDA/CFDA Shortend Registration Appendixes China Medical Device Regulations 4
T The CFDA recently issued new Medical Device Industry Standards China Medical Device Regulations 0
T CFDA issued second list of Class II devices exempt from clinical studies (10/11/13) China Medical Device Regulations 4
T CFDA recently classified 23 products (9/27/13) China Medical Device Regulations 5
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
Q Is Establishment Registration Necessary? Other US Medical Device Regulations 1
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
JoCam Registration of other manufacturers devices UK Medical Device Regulations 3
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M Establishment Registration US Food and Drug Administration (FDA) 3
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9

Similar threads

Top Bottom