Medical Device Registration and Approval in Saudi Arabia
General country-specific regulatory information is provided on this page for medical device registration and approval in Saudi Arabia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Saudi Arabia, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Saudi Arabia
REGULATORY AUTHORITY: Medical devices are regulated by the Saudi Food & Drug Authority or SFDA.
CLASSIFICATION SYSTEM: The SFDA classifies devices according to all GHTF approvals, adopting their respective classification systems.
Medical Devices: The classes will depend on which compliance route is chosen for a submission. For example, EU compliance: Class I, IIa, IIb, III; for FDA Compliance: Class I, II, III, Exempt; etc.
IVD Devices: The classes will depend on which compliance route is chosen for a submission. For example, EU compliance: General, Home Use, list A, list B; for FDA Compliance: Class I, II, III, Exempt; etc.
Medical Devices: Approval typically takes between 35 and 120 working days after files have been submitted to the authorities.
IVD Devices: Approval typically takes between 35 and 120 working days after files have been submitted to the authorities.
Audits: There are no specific audit requirements, but the manufacturer must meet ISO 13485 by Notified Body or FDA inspection. In addition, they may be asked to provide an MDD or EIR audit report when applicable.
Technical Local Tests: No local tests are required.
Clinical Evaluation/studies: No submission of clinical data is required.
Other: Products intended for home use must have their IFU, label and brochure translated into Arabic (in addition to English). In addition, a product description and intended use should be provided in English and Arabic, along with a barcode for each registered model.
Application review fees: The fees for Medical Device and IVD Devices both range between $4 000 – $7 000 USD per product.
Manufacturer registration: An establishment license is required, for a fee of $700 USD, billed annually.
LICENSE VALIDITY: In Saudi Arabia, licenses are valid for 3-5 years, depending on foreign approval.
LICENSE TRANSFER: License transfers are possible in Saudi Arabia, these are held by the manufacturer and the AR is not mentioned in the license at all.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required to register medical devices in Saudi Arabia, this must be a local company that falls under one of the categories on a pre-determined list of company types.
ADDITIONAL INFORMATION: Establishment licensing is a separate process, which should be conducted before registering a product. In 2018, an alternative to the traditional MDMA registration was suggested for class I and general IVD devices. Grouping or amendments are not allowed in this option.
Last updated on April 4, 2019.
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