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Does the manufacturer need to notify SFDA about all of the reportable and not reportable adverse events?

Manufacturer is required to notify SFDA/NCMDR of all reportable adverse events only .

For more information please refer to the SFDA-Medical Devices Sector websitehttp://www.sfda.gov.sa/en/medicaldevices/Pages/default.aspx

  What should the manufacturer do if the recalled device owner refuses to cooperate with the correction plan?

 

The establishment by itself or through its authorized representative is responsible for  communication with healthcare facility  in order to execute the recommended corrective action and shall take all the necessary measure , such refusal shall not waived the responsibility be all means.

What are the items that needs to have temperature indicators?

- In Vitro Medical Devices.

- Non Medical Reagents and Indicators.

what are the designated ports of Entries for Medical Devices?

Out of twenty seven ports of entries in the kingdom of Saudi Arabia, Medical Devices sector is currently located in nine ports only. The ports are listed as follows:

ports

 

When is the medical software considered as a medical device ?

If the software has been classified as a medical device in one or more of the following countries USA, Canada, EU, Japan and

 

Australia , then it is a medical device.

What is the acceptable expiry date of the CE mark to be approved by SFDA?

Three months after the SFDA final  decision.

 

What is the acceptable timeframe of the audit report to be approved by SFDA?

The audit report should not be less than 1 year old.

Should the manufacturer provide a full audit report or a summarized one?

SFDA request a copy of the most recent certification / surveillance / recertification audit report issued by the Notified Body, which is related to the provided certificate. Also there should be an evidence showing that all the non-conformities, if there are any, have been addressed and the Corrective plans has be accepted by the NB and the CE Cert is still valid. The evidence of non-conformity closure can be a letter from NB or a completed non-conformities list from the NB

What can the manufacturer provide when the product has no market literature ?

Where the manufacturer has already prepared advertising and marketing material, intended to be used in the KSA, at the time of application, a copy shall be provided to the SFDA.

As part of the requirements specific to the SFDA, electronic copies of any advertising or marketing material that the manufacturer intends to use in the KSA after the medical device has been authorized to be placed on the market are submitted to the SFDA through the MDMA.

Marketing material includes, for example, product brochures, information on clinical performance, and publications from technical magazines.

Advertising material includes, for example, written material, information available on the internet television or radio, exhibition material and the like, and information available in electronic form.

Advertising and marketing material may be prepared for professional persons, lay persons or both.

Does the responsibility of the Statement for KSA Environmental Factors ends when the product enters Saudi Arabia ?

The instructions for use shall provide information on any measures taken to accommodate the specific non electrical environmental and/or conditions of use encountered in the KSA , such as (a) local operating temperature and humidity conditions and (b) the level of protection of the devices against electro-magnetic disturbances, when applicable.

The applicant is required to provide a statement confirming that the devices will maintain its specified performance when subject to the environmental factors that may be encountered within the KSA.

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