Amit Bechar
Ambient
Hi
Our products are manufactured by a local contract manufacturer in mainland China.
Since we sell our products locally (in China), once the new medical devices registration guidelines take effect (starting 2023), our options will be:
1. create and register a local company in China that will register our products.
2. manufacture outside of China, register our products as imports and distributor via a local distributor
Our contract manufacturer have offered a third option: to register our products under their name.
1. Is there a way for them to register our products while keeping our ownership or is this not allowed under the new registration guidelines?
2. We will provide the funding for the registration, testing, QMS maintenance etc.,
Under what title should they register to make this clear so not to inadvertently provide false information during registry
Thanks
Our products are manufactured by a local contract manufacturer in mainland China.
Since we sell our products locally (in China), once the new medical devices registration guidelines take effect (starting 2023), our options will be:
1. create and register a local company in China that will register our products.
2. manufacture outside of China, register our products as imports and distributor via a local distributor
Our contract manufacturer have offered a third option: to register our products under their name.
1. Is there a way for them to register our products while keeping our ownership or is this not allowed under the new registration guidelines?
2. We will provide the funding for the registration, testing, QMS maintenance etc.,
Under what title should they register to make this clear so not to inadvertently provide false information during registry
Thanks