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.

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.

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.

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.