Medical Devices

Question

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


Answer

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


Question

What is medical device Labelling?


Answer

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.


Question

What is accessory definition?


Answer

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.


Question

What is the medical device definition?


Answer

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.


SFDA & Ministry of Interior (MOI), Observed some Radiology Deviations in 343 Healthcare Organizations

2015-07-28

SFDA & MOI specialist taskforce observed some deviations in radiology departments ( Diagnostic radiology, nuclear medicine and radiotherapy) in 314 healthcare organizations and 29 dental clinics in the different regions of the Kingdom during the field visits conducted to those organizations.

Other News

News List

Fees and Review Times for Authorised Representative Application

Fees and Review Times for Authorised Representative Application
Publication Date
Applying Date
2017-09-25

Guidance on Innovative Medical Devices (MDS – G002)

2022-03-16
Guidance on Innovative Medical Devices (MDS – G002)
Guide
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Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives

2019-05-01
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives
Guide
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MD Application Imaging Products Importation and Clearance

2019-03-02
MD Application Imaging Products Importation and Clearance
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Vaccine recipient guide for (Pfizer- BioNTech) vaccine

2020-05-12
Vaccine recipient guide for (Pfizer- BioNTech) vaccine
Guide
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