Dear friends,
I am aware of the US FDA regulations on Product Registration and Establishment Registration for finished device but wanted to know more about the current SFDA regulations.
We have been approached by our customer to manufacture "components" for a dry powder inhaler in one of our Chinese plants for a device that would be marketed in China.
In the situation as described above, is it required to go in for SFDA's Establishment Registration or Product registration ?
Alternatively, if we assemble and manufacture a finished device (with Pharma ingredient), who is required for product registration - would it be we or our customer ? This is because our customer is of the view that as per SFDA regulation, the "manufacturer" ie. we, are required to submit the product file to SFDA. In case of other regulators, the person holding the design is responsible for biocompatibility and clinical trials and thus its the customer who submits the documents to the regulatory body.
Pls advise and thanks for your information.
I am aware of the US FDA regulations on Product Registration and Establishment Registration for finished device but wanted to know more about the current SFDA regulations.
We have been approached by our customer to manufacture "components" for a dry powder inhaler in one of our Chinese plants for a device that would be marketed in China.
In the situation as described above, is it required to go in for SFDA's Establishment Registration or Product registration ?
Alternatively, if we assemble and manufacture a finished device (with Pharma ingredient), who is required for product registration - would it be we or our customer ? This is because our customer is of the view that as per SFDA regulation, the "manufacturer" ie. we, are required to submit the product file to SFDA. In case of other regulators, the person holding the design is responsible for biocompatibility and clinical trials and thus its the customer who submits the documents to the regulatory body.
Pls advise and thanks for your information.