Saudi Arabia Regulatory Framework Medical Device registration

Saudi Arabian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Saudi Arabian market:

Major Regulations

Regulation	Year
Medical Devices Interim Regulation	2017
National Provisions and Requirements for Medical Devices	2018

Specific Guidance Documents

Document	Year
Barcode FAQ	2015
Guidance for Local Manufacturers	2013
Guidance for Medical Device Authorised Representatives	2013
Guidance for Medical Devices Importers and Distributors	2013
Guidance for Overseas Manufacturers	2013
Guidance on Marketing Authorization Procedures	2013
Guidance on Medical Devices Bundling/Grouping Criteria	2018
Guidance on Post-Marketing Surveilance	2009
Implementing Rule On Licensing Of Authorized Representatives	2018
Implementing Rule On Marketing Authorization	2018
Implementing Rule On Post-Marketing Surveillance	2018
Implementing Rule on Designation and Oversight of Conformity Assessment Bodies	2010
Implementing Rule on Establishment Licensing	2018
Implementing Rule on Establishment Registration	2018
Implementing Rule on Medical Devices Listing	2018
Implementing Rule on Safeguard Procedures	2018

Additional Information

Document	Year
Authorised Representative application fees and review times	2010
Establishment licensing application fees and review times	2010
Marketing Authorization application fees and review times	2019

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