We are using a contract manufacturer to manufacture some of our products, these products are TGA class IIa non sterile products (nebuliser and mask). Our contract manufacturer have CE marking and EC certificate to manufacture mask but they do not have EC certificate to manufacture nebuliser as they exclusively manufacture for us and their local market (different design) that does not require CE marking requirement.
We have conformity assessment certificate from our notified body to manufacture nebuliser and mask. Contract manufacturer supply some finished product that we simply re-distribute and some bulk-finished product we do the packaging.
My question is;
Whether its necessary for the contract manufacturer to have their nebuliser included under their EC certificate or they do not necessarily need to include nebuliser in their EC certificate considering we are taking whole responsibility of the manufacturing.
Thanks
We have conformity assessment certificate from our notified body to manufacture nebuliser and mask. Contract manufacturer supply some finished product that we simply re-distribute and some bulk-finished product we do the packaging.
My question is;
Whether its necessary for the contract manufacturer to have their nebuliser included under their EC certificate or they do not necessarily need to include nebuliser in their EC certificate considering we are taking whole responsibility of the manufacturing.
Thanks