SFDA now asks for "Certification to ISO 10993-1" for class III device?


Dear all, has anyone seen or heard of this before?

We were approached by the Saudi-Arabian distributor with regard to a change in regulation applicable to medical devices.
Our class III device was registered in Saudi-Arabia last year, after submitting the CE certificate and TD.

They are now asking for a specific "Certification for ISO 10993-1".

This certification should
- be done by an official institution (may be laboratory, other possibility was not clearly described to us)
- be listed in an official registry to be checked online by SFDA (similar to CE certificates).

The Certificate of Conformity shall include or have an attached gap analysis for the respective device for applicable ISO 10993-1 requirements.

Writing our own Certificate of Conformity to this standard is not an option and will not be accepted.
We have already sent detailed information on biological evaluation, including a gap analysis, and it was accepted by SFDA at first. Now it is not longer sufficient.
We also tried to find out if there may be an interpretational error, and SFDA has asked for a certificate and not a certification. This was negated by the distributor.

Question no. 1:
Have you heard of this kind of certification to ISO 10993-1?

Question no. 2:
Have you heard of a similar request and can you tell us a solution to satisfy the authority´s demand?

Looking forward to your competent advice.



Quite Involved in Discussions
I'd take a look at the website for the accreditation body for your country (e.g. UKAS for the UK), look at their register of test houses capable of performing testing to ISO 10993 and speak to one of these labs for their guidance.


Thanks, Dan, I already checked.
And asked an accredited lab who told me they have never heard of this kind of certification either.
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