A well-prepared Performance Evaluation Report (PER) is essential for demonstrating the safety, effectiveness, and regulatory compliance of IVD medical devices in the Saudi market.
Saudi Arabian distributors play a crucial role in the healthcare supply chain, ensuring that medical devices reach the market in compliance with local regulations.
Saudi Food and Drug Authority ensures that medical devices used in the Kingdom of Saudi Arabia meet high standards of safety and quality in today's evolving healthcare landscape
Medical Device Marketing Authorization (MDMA) ensures that medical devices entering the Saudi market meet regulatory standards set by the Saudi Food and Drug Authority (SFDA).
Authorized Representatives (ARs) play an important role in the regulatory process. Medical device industry professionals or those looking to launch products in new markets
Post-Market Clinical Follow-up (PMCF) is a crucial aspect of maintaining the safety and effectiveness of medical devices after they have been introduced into the market.
SFDA has introduced stringent regulations for Saudi-DI for all medical devices marketed within the Kingdom.
Self-testing devices, also known as home diagnostic devices, allow individuals to perform health tests on themselves, interpret the results, and take action based on the results.
Standard Operating Procedures (SOPs) and audit reports are two of these critical components. By working together, they ensure compliance with best practices, compliance with regulatory requirements, and continuous improvement within the organization.
Reliable diagnostics are essential for public health, making it imperative to understand the regulatory frameworks that govern these devices.
An ISO 13485 quality management system (QMS) specifies requirements for the design and manufacture of medical devices
Modern healthcare relies heavily on in vitro diagnostic (IVD) devices to provide essential data that allows clinical decisions to be made.
Essentials of the National Medical Device Reporting (NCMDR) system, explaining its purpose and key requirements for reporting medical devices.
This outlines the Saudi FDA's classification and registration process for medical devices, offering key insights for manufacturers navigating the regulatory landscape.
Here you’ll find the latest blogs about compliance news and guidance for all medical industries.
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