Saudi Arabia Blog Posts

MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices?

EMERGO SUMMARY OF KEY POINTS

  • Low-risk medical device manufacturers may now choose between Medical Device Market Application (MDMA) and Medical Device National Registry (MDNR) registration pathways in Saudi Arabia.
  • The SFDA’s MDNR route is faster, but some Class I non-sterile, non-measuring device manufacturers may still benefit more by undergoing MDMA registration.
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Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) has officially announced a new market pathway for Class I non-sterile, non-measuring devices that does not require Medical Device Marketing Authorization (MDMA).
  • Qualifying low-risk device manufacturers may list their products in the Saudi Medical Device National Registry (MDNR) in lieu of MDMA premarket review.
  • Implementation timeframes for the new non-MDMA market pathway have not yet been disclosed.
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Saudi Arabian Regulators May Exempt Some Low-Risk Medical Devices from MDMA Registration

EMERGO SUMMARY OF KEY POINTS:

  • Saudi medical device regulators have unofficially indicated they may soon exempt certain Class I devices from MDMA registration requirements.
  • Class I non-sterile, non-measuring devices would still require Saudi Arabia Authorized Representation in order to be commercialized in the country.
  • The Saudi Food and Drug Authority (SFDA) may push through the new exemption in the next month or two.
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Medical Device Marketing Authorization (MDMA) Application Changes Planned in Saudi Arabia

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority plans to require more clinical data for some Medical Device Marketing Authorization (MDMA) applications.
  • Details and timeframes for the new requirements are forthcoming from the SFDA.
  • Additional clinical data the SFDA may require of applicants includes clinical evaluation reports (CER), post-market surveillance plans and post-market clinical follow-up (PMCF) reports.
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Saudi FDA Allows “Compassionate Use” Program for Some Medical Devices

EMERGO SUMMARY OF KEY POINTS

  • The Saudi Food and Drug Authority has implemented a process for importing medical devices into the country to address national emergency situations.
  • Manufacturers must meet importation licensing and shipping clearance documentation requirements under the new program.
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Saudi FDA to Regulate Borderline Products as Pharmaceuticals

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) now regulates some borderline products as drugs rather than medical devices.
  • For affected products currently registered with the SFDA as medical devices, their registrations will remain valid until they expire.
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New Medical Device Barcodes Required by Saudi Regulators

New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.

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Saudi Regulators Issue New Guidance on Investigational Medical Devices

The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country.

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Thinking about entering Middle East markets? Avoid these 3 common mistakes made by "Westerners"

In my 25+ year career working with multinational device companies, I have worked with a lot of American and European executives. The vast majority are smart and well intentioned. But time after time, companies new to the Middle East market make the same mistakes. Often, those mistakes are deeply rooted in culture.

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