Confidentiality of information during MD registration worldwide

#1
When registering medical devices in certain countries, we are asked to provide a certain amount of proof of good design and manufacturing/development practices, V&V, clinical data, etc...
Recently, for an Asian country, the regulatory authority asked us a lot of questions about our machine-learning algorithms, including how they work, how the data is validated.
This data is highly confidential. To what extent can we refuse to transmit information and how can we protect ourselves from information leakage, from counterfeiting...? (apart from signing an NDA)
 
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