Qatar: MOPH Obligates Document Authenticity Verification for IMD Registration (1 October 2023)

Ministry of Public Health (MOPH) released Circular NO (DHP/2023/100) on 12 September 2023 extending the commission by Ministerial Resolution No. (4/2020) on ensuring the quality and safety of Implanted Medical Devices (IMD) distributed in Qatar are secured by the Primary Source Verification (PSV) process.

Starting from 1 October 2023, all manufacturers, distributors, and representatives for IMD are required to undergo the Primary Source Verification process by obtaining Credentials from DataFlow in order to submit for authenticity verification of the registration application documents. So, only the verification reports licensed by DataFlow are accepted, not from the notarization or attestation process.

The IMD registration documents that are subjected to the authenticity verification process are:

• Manufacturer registration certificate

• CE or FDA certificates from the country of origin, including IMD reference codes

• Free Sale Certificate (FSC) from the country of origin, including IMD reference codes

All responsible manufacturers, distributors, and representatives involved with the implanted medical devices activity in Qatar are advised to pay attention to the new regulatory requirements. Please click on the link below to view the process details.

Source: Ministry of Public Health (MOPH)

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