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Saudi Arabia Technical File Requirements

jiligan

Involved In Discussions
#1
I am currently working on a registration for Saudi Arabia and a 3rd party consulting group informed me that the KSA is putting into force the technical file requirements as laid out in MDS-G5. Stating that they submitted a registration in August for another company and the SFDA requested the complete technical file. This regulation was not supposed to go into effect until January 1, 2021and someone else stated that they thought the technical file requirement was extended to March 22, 2021? Does anyone know when this requirement is actually going into effect/went into effect? Has anyone submitted a registration for a class IIb/Class C device since August and if they were required to submit the complete technical file? I was under the assumption that I could submit the registration based on EU equivalency and that it did not include the complete technical file? Thank you for your help - it is greatly appreciated!!
 
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Mikilk

Involved In Discussions
#2
I am currently working on a registration for Saudi Arabia and a 3rd party consulting group informed me that the KSA is putting into force the technical file requirements as laid out in MDS-G5. Stating that they submitted a registration in August for another company and the SFDA requested the complete technical file. This regulation was not supposed to go into effect until January 1, 2021and someone else stated that they thought the technical file requirement was extended to March 22, 2021? Does anyone know when this requirement is actually going into effect/went into effect? Has anyone submitted a registration for a class IIb/Class C device since August and if they were required to submit the complete technical file? I was under the assumption that I could submit the registration based on EU equivalency and that it did not include the complete technical file? Thank you for your help - it is greatly appreciated!!
according to the official regulations in KSA, it is a new requirement that will be implemented soon (2021), currently, the authorities are doing a random inspection of a full technical file review, it happened to one of our clients - during the registration process the MOH asked for a full technical file, but we got the license a few days after we sent the file so we believe it was not a comprehensive review.
 
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