FAQ

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FAQ
Answer
What is Quality Assurance Certificate?   It is a certificate issued be a recognized certifying body ensuring that the medical device is manufactured as per international standards.
Examples of Quality Assurance Certificates.  

FDA, CE Mark, ISO 13485, SFDA.

If the medical device is registered in SFDA, do I have to submit ISO and CE Mark?  

No, SFDA will be enough and no need to submit other quality assurance certificates.

When the QAC is rejected?  

The QAC is rejected due to many reasons:

· Not verified.

· Not valid (expired or canceled).

· The scope of certificate not matching with the item.

· Certificate is issued for another manufacture than the one in the invoice

             . Certificate is not issued from a recognized certifying body.

How can I verify the Quality Assurance Certificates?   Visit the website of the certifying body, enter the certificate number and capture (screen shot) the validity OR contact the certifying body by sending an email with a copy of the certificate to be verified and put medical_devices@nhra.bh email in CC.
How can I know if the certifying body is recognized or not?  

For CE mark, please visit “European Commission”                          

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main

 

For ISO 13485, please visit IAF website:

https://www.iaf.nu//articles/IAF_MEMBERS_SIGNATORIES/4