Introduction The Saudi Arabian Medical device registration and approval is governed by the Saudi Food and Drug...
Unlocking Opportunities: Understanding Saudi Arabia’s Medical Device Approval
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Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia
In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down...
Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence
Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can...
IMDRF guide on Post Market Clinical Follow-up Studies (PMCF)
PMCF is a continuous process that updates the manufacturers' clinical evaluation during the Post-market surveillance....
Medical Device Registration in Saudi Arabia
Medical Device Registration Saudi ArabiaMinistry of Health: Ministry of Health Regulatory Authority: ...
UDI DI
UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally...
Cosmetics Registration in Saudi Arabia
Cosmetics Registration in Saudi ArabiaRegulatory Authority: Saudi Food and Drug Authority (SFDA) Link for RA:...
Saudi Arabia
Saudi Arabia Medical Device Regulations Regulatory Authority: Medical Device Sector, Saudi Food & Drug Authority...
Iraq Medical Device Registration: KIMADIA Guidelines and Requirements
Navigating Medical Device Registration with Iraq's Regulatory Authority: KIMADIA Guidelines and Requirements ...
License Transfer for Medical Device to New Sponsors from Existing License Holders
License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and...
The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR
Clinical evaluation is a continuous procedure that happens at every stage of a medical device's life cycle. It is...
Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance
The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory...