Ghad sfda. Saudi Arabia

Product label, which must meet Labelling criteria of SFDA• Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions Therefore each item shall be recorded individually in Saudi-DI system
SFDA announced that both guidance are dedicated to innovative medical devices and new applicable standards and have been developed during the process of making general improvements to the medical device regulatory framework EU Jurisdiction — Registration Requirements• Link Medical Devices Importing License System "MDIL" is a Licensing system for the establishments involved in the importation of medical devices in Saudi Arabia

Saudi Arabia

This provides a respite to companies that may have failed to complete the process before the end of the 2019 calendar year.

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Documents Required Besides the general requirements described hereinabove, the guidance also provides a list of documents to be submitted by the entity applying for the importation license with regard to medical devices intended for demonstration or training purposes only
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General information about the manufacturer, including its name, full address, and contacts details,• GHAD migration deadline pushed back The SFDA declined to publicize a second deadline extension, this time for submitting Medical Device Marketing Authorization MDMA applications using the old electronic system
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Identify the SFDA medical device classification
Related Saudi Arabia medical device market resources from Emergo by UL:• The Public Consultation Platform is an e-portal that offers data about private and public sectors as well as the mass, these data are usually results of questionnaires about their experience with services and systems offered by governmental sectors and focused around the developmental and economic ecosystems An online tool that the NCC uses to engage the private sector in the identification of the challenges they face, and in the formulation of the policies and regulations to address them The present SFDA guidance is intended to provide additional clarifications regarding the requirements the interested party shall fulfill in order to be able to obtain an importation license
Such devices are exempt from mandatory registration The present document constitutes an amended version of the guidance issued by the Saudi regulating authority earlier in 2016 and amended later in 2018

Saudi FDA extends GHAD deadlines, issues guidance

The new system, , provides a single platform for submitting Medical Device Marketing Authorization MDMA , Medical Device National Registry MDNR , Saudi Authorized Representative and related applications to SFDA.

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Saudi regulators launch Ghad online medical device marketing application system
Notified Body name with their number• Saudi Arabia medical devices approval process We can summarize the registration process of a medical device in Saudi Arabia in the following few steps:• Medical devices establishments wishing to import medical devices intended for demonstration or training purposes only,• In particular, the application form contains the following sections:• Medical device companies can initiate updates in the application at any time in the existing documentation
Saudi FDA extends GHAD deadlines, issues guidance
In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers
Saudi Arabia SFDA: New Online System GHAD Replacing Old System Hits The Local Registrants
Rules and Requirements The present SFDA guidance outlines the main rules and requirements to be applied in case of medical devices intended for demonstration or training purposes, namely:• The requirements described in the document are based on the provisions of the Interim Regulation which governs all aspects related to placing medical devices on the market