Medical devices registration process in Saudi Arabia and cosmetic products Questions

Find Below General Questions concern medical devices registration process in Saudi Arabia and cosmetic products approval with Saudi FDA and Their Answers , if you don’t find your answer there don’t Hesitate to contact us .

    Medical Devices FAQs

What is Interim Regulation in Medical Devices Sector (MDS) of Saudi Arabia and what does it intend to achieve?
Why do we need to assign an Authorized Representative?
Who might be selected to assign as an Authorized Representative?
Why is it better to assign an independent Authorized Representative rather than agent, distributor and importer?
What tasks does Bio-Standards perform as your Authorized Representative?
Does Bio-Standards also act as a distributor or has a business of such nature?
What is the Medical Devices National Registry (MDNR) ?
What is Medical Devices Marketing Authorization (MDMA) and why is it important?
What is the given time to pay the MDMA application fee after requesting payment by SFDA?
Is all the information that we place with Bio-Standards confidential?
Why do we need to place a partial technical file with our Authorized Representative in Saudi?
Do we have to put the name of the Authorized Representative on our labels, packaging and IFUs?
what are the designated ports of Entries for Medical Devices?
What does label mean?

 

   Cosmatic Products FAQs

Is it mandatory to register cosmetic products at SFDA before import?
Is there a list of the companies approved to issue certificates of conformity?
What are the conditions related to certificates of conformity?
Is it possible to import products accompanied by certificate for standards other than standards issued by SASO?
I wish to ensure compliance of the product’s label to what is approved by SFDA?
I would like to importer products but I am not entirely certain whether it is considered cosmetic product or medicine?