Outsourcing registration to a local company

[Amit Bechar]

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

 

[TimZhao]

1. create and register a local company in China that will register our products.
advantage : You own your product certificate and can authorize manufacturer to produce for you.
disadvantage : You have to establish local MD company and fulfill China GMP, it's a huge project. from timeline, cost etc..
2. manufacture outside of China, register our products as imports and distributor via a local distributor
disadvantage : the most local distributor will tell you that without their permission, you can not choose other distributors since the product license kept in their hand.

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
regards to the above concerns, the current contract manufacturer as your local China agent to register your product. but , honestly, you can not control the status and hardly to know the information is correct or false. because the contract manufacturer they totally can register it as their own product(because they have the manufacturing capacity and some technical docs) even you signed the contract with them, the all submission files are Chinese.

therefore, i would recommend your firm to seek the independent local 3rd party regulatory provider as your local authorized China Agent on behalf of you to register your product in NMPA. we do not involve in your business activity. you can select as many as qualified distributors and the LAR can authorize them and support you to inspect them on demand. You are the certificate owner. furthermore, if your firm considers to create local facility in China in future, the independent LAR can support you to transfer the Product license.