Regulatory Compliance

Understanding SFDA and Its Role in Medical Device Regulation The Saudi Food and Drug Authority (SFDA) regulates the importation, registration, and approval of medical devices to ensure that only safe and high-quality products are available in the Saudi Arabian market.  Through a structured and transparent review system, the SFDA ensures that all medical devices comply […]

Introduction Medical device companies operate in one of the most highly regulated industries in the world. From design and development to manufacturing and post-market surveillance, every step requires strict compliance with standards and regulations. A key part of achieving and maintaining compliance is training management for medical devices. Training ensures that employees understand regulatory requirements,

In the medical device industry, ensuring that every design decision aligns with safety and regulatory expectations is critical. Design Qualification (DQ) plays a vital role in the validation lifecycle, while ISO 14971 sets the global framework for risk management in medical devices. When connected effectively, these two elements ensure that devices are not only functional

Introduction When manufacturers think of the FDA 510(k) pathway, the focus is usually on Class I and Class II medical devices that require premarket clearance. But what happens when a device does not clearly fall into any existing FDA classification? This is where Unclassified Medical Devices from 510(k) come into play. Understanding this special category

SaMD Software Documentation:An Overview As Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) continue to transform modern healthcare, regulatory bodies like the US FDA have established stringent documentation requirements for premarket submissions.  If you’re planning to bring your software-based medical device to the US market, the Center for Devices and

Overview of Medical Device Labeling and Its Regulatory Importance Medical device labeling is a critical element of regulatory compliance and user safety. For manufacturers aiming to market medical devices globally, accurate and compliant labeling is not optional—it’s a mandatory requirement enforced by regulatory authorities such as the US FDA, the EU under MDR, and various

Effective from January 10, 2025, medical device and in vitro diagnostic (IVD) manufacturers operating within the European Union must comply with new regulatory obligations to ensure the continuity of medical device supply. The introduction of Regulation (EU) 2024/1860 establishes mandatory advance notification requirements for manufacturers planning to discontinue or interrupt the supply of medical devices

How to Get Legacy Devices to IVDR Compliance The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) marks a significant regulatory overhaul for manufacturers in the EU market. Legacy IVD devices—those already placed on the market under the IVDD—must now meet stricter requirements under the IVDR (EU 2017/746)

If you’re part of the medical device industry in India, you’ve likely come across the term UCMPMD Guidelines. These guidelines were introduced to promote transparency and ethical marketing practices within the medical device sector. Every medical device company is expected to file a self-declaration and disclose their marketing expenditure regularly. But what does this actually

Introduction to Clinical Trial Conducting a clinical trial is a pivotal step in the development of any medical device. A successful trial ensures the device’s safety and effectiveness, facilitates regulatory approvals, and builds credibility with healthcare providers and patients. However, Clinical Trial Management for medical devices is a complex and resource-intensive process that leaves no room for