The Saudi Food And Drug Authority recommends ISO 13485 as one of the required certifications for medical device manufacturers. Today we are going to look at some FAQs that will help businesses better understand the certification.

Q: What Constitutes A Medical Device?

A: A medical device is any apparatus, implement or instrument that is utilized for the purpose of medical procedures.

Q: What Does The Manufacturer Needs Must Report To The SFDA?

A: The device manufacturer is required to report to the SFDA about all reportable adverse events.

Q: Is ISO 13485 Certification Required For International Markets?

A: ISO 13485 certification is a necessary prerequisite for trading in international domains. 

For ISO 13485 Certification, ISO 13485 Consultancy , ISO 13485 Consultants, ISO 13485 SFDA requirements, in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf drop an email to [email protected].