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If there are many deferent types of accessories related to the medical device, is it allowed to register them in one application?

Yes, it is allowed if they are made for the main medical device

What is the deadline to do the payment fee of medical device marketing authorization (MDMA) when it is requested from Saudi Food and Drug authority?

The payment fee of MDMA must be done during 30 calendar days 

What are the requirements of soft contact lenses (Cosmetic and or/ Correction Lens) and contact lenses solutions?

You can find guidance MDS-40 on:
https://sfda.gov.sa/sites/default/files/2020-03/MDS-G40en.pdf

What does mean, “The timeframe for returned MDMA application is 60 calendar days” in announcement (8) 8/2019?

Means the total days of ALL 3 cycles is 60 days to fulfill all the requirements. In occasions where applicant have a valid justification to extend the response period for SFDA’s observations to more than 60 calendar days, such requests must be emailed to
mdma.it@sfda.gov.sa.

What is medical device Labelling?

Means written, printed or graphic matter
a) Affixed to a medical device or any of its containers or wrappers.
b) Information accompanying a medical device, related to identification, technical description.
c) Information accompanying a medical device, related to its use, but excluding shipping documents.

What is accessory definition?

Means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.

What is the medical device definition?

means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar that Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
Diagnosis, prevention, monitoring, treatment or alleviation of disease,
o Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
o Investigation, replacement, modification, or support of the anatomy or of a physiological process,
o Supporting or sustaining life,
o Control of conception,
o Disinfection of medical devices,
o Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body

and any device which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

I would like to importer products but I am not entirely certain whether it is considered cosmetic product or medicine?

It can be ensured that the product to be imported are cosmetic products by implementing the definition of cosmetic products of SASO 1953 (Cosmetic Products – The Cosmetic Product (Safety) Regulations), and it is possible to apply to SFDA to classify whether it requires registration as medicine or not.

I wish to ensure compliance of the product’s label to what is approved by SFDA?

Compliance of the product label can be ensured by implementing the requirements of SASO 1953 (Cosmetic Products – The Cosmetic Product (Safety) Regulations), this and other cosmetic products related standards can be obtained from SASO website at the moment, and in the future from the SFDA website.

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