Only Face Masks with medical claim are regulated by NHRA and in order to get the approval, the following should be provided:
1-CR needs to be provided and includes Medical device importation activity.
2- Proforma Invoice (If it is not issued by the Legal manufacturer, please provide authorization letter from the legal manufacturer to the invoice issuer).
3- Face mask catalog.
4- Artwork (Label).
5- Verified NIOSH, FDA, or CE mark matching the face mask manufacturer and model.
6- FDA establishment registration and device listing is not accepted. Please provide the FDA Emergency Use Authorization or the Certificate to Foreign Government.
7- For N95 respirators, EN14683 is not enough, passing of EN149 test would need to be provided.
View More
© Copyrights 2026. National Health Regulatory Authority, Kingdom of Bahrain, All Rights Reserved.