Skip to main content

Question

What are the medical devices clearance conditions and requirements ?


Answer

  Medical Device clearance conditions and requirements are published at: (Click here)    


Checklist for Quality Manual Form

2023-08-06
Checklist for Quality Manual Form
Has the page content helped you?

Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

2023-10-16
Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)
Requirement
Has the page content helped you?

SFDA, HPRA Discuss Areas of Future Cooperation

2023-05-08

His Excellency the CEO of the Saudi Food and Drug Authority(SFDA), Dr. Hisham bin Saad Aljadhey, and his accompanying delegation met today, Monday, with the CEO of the Irish Health Products Regulatory Authority (HPRA), Dr. Lorraine Nolan.

This visit comes on the sidelines of SFDA official participation at the 4th meeting of the International Heads of Food Agencies Forum (IHFAF) taking place this year in Ireland.  

Other News

SFDA Recommends to Test Blood Sugar at Home Two or Three Hours after Meals

2023-04-05

The Saudi Food and Drug Authority (SFDA) has recommended performing a home blood sugar test two to three hours after meals to ensure the device's safety and accurate readings. If blood sugar (glucose) levels increase during fasting, the SFDA recommends seeking medical attention from a specialist.
In addition, the authority recommended examining the glucose test strip's expiration date, buying devices that save previous measurements, washing and drying hands before a test, estimating how much blood was drawn, and inserting the test strip in the appropriate location.

Other News

SFDA Provides Five Tips for Using Home Blood Pressure Monitor

2023-04-02

The Saudi Food and Drug Authority (SFDA) recommended against taking a blood pressure reading if you are feeling anxious, just after exerting yourself physically or mentally, or if your bladder is full.
To make it easier to wrap the blood pressure measuring band around the arm, the SFDA advised setting the feet parallel to the floor, supporting the back to sit upright, and bending or taking off any clothing that was around the arm.

Other News

Requirements for Transporting and Storage of Medical Devices (MDS – REQ 12)

2023-03-28
Requirements for Transporting and Storage of Medical Devices (MDS – REQ 12)
Requirement
Has the page content helped you?

Guidance on Manufacturing Paths of Medical Devices (MDS-G011)

2023-10-15
Guidance on Manufacturing Paths of Medical Devices (MDS-G011)
Guide
Has the page content helped you?

Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012)

2023-03-22
Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012)
Guide
Has the page content helped you?

GHWP Leaders Stress Importance of Supporting Innovation, Convergence in Medical Devices Regulations, Legislation Between Countries

2023-02-16

 

Other News

Subscribe to Medical Devices