K
kbryde
Hi all,
We have IVDs registrated in the KSA, and the registrations are about to expire - which should be no problem, just renew them, but....... We have chosen to use our CE-marking as the basis for our registrations, and now that seems to pose a big problem: The registration in KSA will expiry on the same date as our CE certificate/ISO 13485 certificate - renewal needs to begin 6-8 months prior to expiry AND we need to provide a NEW CE/ISO certificate for this.......??????
My question is, do companies just accept this and move their certification audits by their NBs up by 6-8 months for each re-certification?? Has anyone tried to challenge the SFDA on this, and would they accept that the certificate is delivered AFTER renewal of the registration? I?m a little confused and VERY frustrated and the SFDA is not very informative on the issue
Help, thoughts, suggestions are all very much appreciated!!
/kbryde
We have IVDs registrated in the KSA, and the registrations are about to expire - which should be no problem, just renew them, but....... We have chosen to use our CE-marking as the basis for our registrations, and now that seems to pose a big problem: The registration in KSA will expiry on the same date as our CE certificate/ISO 13485 certificate - renewal needs to begin 6-8 months prior to expiry AND we need to provide a NEW CE/ISO certificate for this.......??????
My question is, do companies just accept this and move their certification audits by their NBs up by 6-8 months for each re-certification?? Has anyone tried to challenge the SFDA on this, and would they accept that the certificate is delivered AFTER renewal of the registration? I?m a little confused and VERY frustrated and the SFDA is not very informative on the issue
Help, thoughts, suggestions are all very much appreciated!!
/kbryde
