What are the fees of marketing authorization application and how long does it take to issue?
Answer
You can reach to fees of marketing authorization application via:
https://sfda.gov.sa/sites/default/files/2019-10/Fees-Rev-Times-Mark-Aut-App-ar%2Cen_9.pdf
the marketing authorization will be issued during 35 business days as maximum if all requirements are fulfilled.
Question
"how can I check if a product has marketing permission or not? "
Answer
You can check if the medical product has already obtained marketing permission via:
https://sfda.gov.sa/ar/medical-equipment-list
or
You can send an inquiry about the product to the following email: md.rs@sfda.gov.sa
including (manufacturer name, brand name, model).
Question
"How medical devices classification must be performed"
Answer
The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories.
You can reach the Guidance on Medical Devices Classification via:
https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf
Question
What is Unique Device Identification (UDI) for Medical Devices?
Answer
The UDI intends to unambiguously identify any medical device based on a globally accepted identification and coding standard that is accredited by regulatory bodies such as GS1, ICCBBA, HIBCC.
You can visit Unique Device Identification (SAUDI-DI) system and viewing the frequently asked questions about the system through:
https://udi.sfda.gov.sa/
Question
If there are many deferent types of accessories related to the medical device, is it allowed to register them in one application?
Answer
Yes, it is allowed if they are made for the main medical device
Question
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?
Answer
The payment fee of MDMA must be done during 30 calendar days
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.
