Die Saudi Food and Drug Authority (Saudi FDA) hat die Fristen für die Erfüllung der Anforderungen nach Risikoklassen für die Registrierung in ihrer neuen UDI-Verordnung und UDI-Datenbank bestätigt.
Sie können die vollständige Erklärung auf Englisch hier lesen.
Falls Sie diesbezüglich Fragen haben, kontaktieren Sie uns gerne unter healthcare@atrify.com.
The Saudi Food and Drug Authority (Saudi FDA) has confirmed the compliance dates by risk class for registration in their new UDI regulation and UDI database.
atrify is working with the Saudi FDA to offer seamless UDI registration, right from the go-live in 2021. This fits perfectly with our value proposition for manufacturers, enabling them to use atrify to connect to all existing and upcoming UDID databases across the globe. Currently, atrify already offers this service for manufacturers who need to fulfill obligations in the United States (GUDID), China, and for EUDAMED (once it goes live).
The final dates for UDID registration are as follows:
Class D (High risk) – 1 August 2021
Class B & C (Medium risk) – 1 February 2022
Class A (Low risk) – 1 February 2023
The direct marking is going to start one year after the aforementioned dates.
SFDA’s ABCD classification mirrors the MDR and IVDR classifications:
MDR Class III = SFDA class D = IVDR Class D
MDR Class IIb = SFDA class C = IVDR Class C
MDR Class IIa = SFDA class B = IVDR Class B
MDR Class I = SFDA class A = IVDR Class A
If you have any questions, please contact us at healthcare@atrify.com.
