Dr. Shaloo Sood Kuthiala
Medical Devices Verification & Validation
< 1 min reading time
Looking for some insight and help from the experienced members fo the group.
Normally it is possible to sell a product in a country as soon as it is registered. As soon as the registration is expired, no import is possible anymore.
However, for China we handle it differently: The manufacturing date of the medical device has to be after the licence approval date. For instance, if we have a licence valid from 01.March2019 to 28.February2024 the manufacturing date of devices shipped to China has to be within this time frame.
That means, we cannot ship devices manufactured before 01.March2019 but on the other hand we could still ship devices in March 2024 (after licence expiry), as long as the manufacturing date was 28.February2024 or earlier.
However, this approach is causing difficulties for our logistics and it is always questioned internally, if this is really an CFDA requirement.
So, I would like to know how other MD companies handle it.
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