Saudi Arabia – SASO and CAP (Conformity Assessment Program) do not apply to Medical Devices – FSC is the best tool to enter this market

SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity  Assessment routes that are allowing manufacturers worldwide to enter the  market of Saudi Arabia with their products. This is in order to ensure  some key objectives such as: Protection of public health, Consumer  safety, National security, Protection of religious and public morals and  environment, Prevention of deceptive practices.

Practically, SASO and CAP are specific tools for Customs Clearance  representing an assumption of compliance with the Saudi Arabian  standards. They are applicable to all goods entering the territory of  Saudi Arabia, but not to medical devices.

For Medical and In Vitro Diagnostic Devices, the best (and only) tool easing the access to this market is the Free Sales Certificate which allows the manufacturer to prove the compliance of his devices  with the EU safety standards. These EU standards are  fully accepted and  welcomed as the best possible ones – also in Saudi Arabia. The same  principle is applicable in other countries that preview Conformity  Certificates and accept EU Standards, such as Algeria, Egypt, Kuwait,  Qatar, Belarus, Kazakhstan, Armenia and Kyrgyzstan.

If you would like to enter the markets of these or any other countries with your medical devices, please do not hesitate to contact us!

Contact our Free Sales Certificates experts, and let us guide you in your conquest of the global market!

Davide Turchi

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