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Circular No. (12) 2018
Date: 4 November 2018
To All Medical Device Importers
‘Sub: The mechanism of importing medical
devices and supplies from a third party
Inon-manufacturer|
From the perspective of ensuring the safety
and quality of medical devices and supplies
during transportation and storage, thus to
avoid the importation of counterfeited
Medical Device, the National Health
Regulatory Authority have monitored many
counterfeited devices, or products shipped
and stored in non-compliance standards,
whereas these products have been found to
be manufactured or even shipped without
the authorization of the legal manufacturer.
Therefore the following mechanism has been
developed:
If the shipment is imported from a third
party, please provide us with a letter from
the factory confirming that the shipment was
manufactured from the legal manufacturer.
This mechanism will be implemented within
one month from the date of this circular.
Your cooperation is highly appreciated in
improving health services in the Kingdom.
owpaulistion
Kingdom of Banrain
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1973.17 113333
srs 13359
0. Box: 11464, Manama
Kingdom of Bahrain
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eMail: infosnhra.bh
Website : wwwhva.bh