Hello everybody,
I am asking you for advice you on behalf of a Client of ours, an Italian manufacturer, in need of some information regarding the Israeli Registration Holder, IRH. The questions I have are aimed at understanding if the manufacturer is free or is able to free themselves from the entity (local distributor, for instance) who requests the product registration as IRH, should the partnership with this entity turn out to be unreliable and/or unprofitable.
More specifically:
1) Can the same product be registered several times by different people/IRH at the same time?
2) If the (foreign) manufacturer decides to designate a certain entity (for instance, the local distributor) as their IRH to proceed with the registration of the medical device, would it be possible to switch this person in the future without the IRH’s consent? In such case, would the registration of the product remain valid? Or would the manufacturer need to designate a new IRH and request a new product registration?
I am grateful for any piece of information you may be able to provide me (and hope to reciprocate in the near future).
Best regards,
Maya Tanase