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

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

Specific Guidance Documents

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

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


Reach out to us and we will help you clarify your situation