If a product has the same manufacturer but multiple distributors, does each distributor require a Medical Device Establishment License?

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  • If a product has the same manufacturer but multiple distributors, does each distributor require a Medical Device Establishment License?

Each premise where medical devices are stored or trade activities for medical devices are conducted, with the exception of those companies who solely supply non-sterile, non-measuring Class A device which have been deemed exempt.

Thus, each distributor would require their own Medical Device Establishment License.

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