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Oct 31, 2024
Pharmaceutical Consulting
Managing Changes to Registered Medical Devices
In the ever-evolving healthcare landscape, managing change notification to registered medical devices is critical to maintaining their safety and performance in accordance with Essential Principles Checklist of Standards claims. With regulations becoming stricter, manufacturers and stakeholders need a clear understanding of the necessary procedures involved in handling updates, modifications, and post-registration changes. This article breaks down the key aspects of managing changes to registered medical devices in Singapore, offering insights into regulatory requirements and best practices to help you stay compliant and keep your devices performing at their best.
Types of Changes
Change notification to registered medical devices can encompass various modifications, ranging from minor adjustments to significant alterations. These might include software upgrades, design modifications, material changes, or even notification updates. It’s essential to understand the type of change, as each one can require different levels of regulatory review. Identifying the nature of the modification helps manufacturers take the proper steps to stay compliant and keep their devices safe and reliable.
Regulatory Requirements
When the product owner initiates a change notification for a locally affected medical device, the immediate steps to take include performing a gap analysis between the registered information pertaining to the medical device versus the changes made by the product owner. The change should be classified as technical, administrative or notification-based, according to GN 21, GN 24 and GN 25 as applicable.
Next, prepare the requirement documentation required under each category of change before submitting to HSA. Following these steps will ensure that you have all the necessary documents to confirm that the changes have been validated and will not affect the safety and performance of the device for its intended users in the local market. Clear and timely communication with regulators helps prevent delays and ensures the modification process runs smoothly.
Risk Assessment
Conducting a risk assessment according to ISO 14971 is an integral part of managing medical device changes. This change control process involves evaluating how a modification might affect the device’s safety and performance. Identifying potential risks allows manufacturers to take the right measures to address them. A thorough risk assessment not only helps protect patient safety but also shows compliance with regulatory standards, reflecting the manufacturer’s dedication to maintaining high-quality products.
Post-Market Surveillance
Post-market surveillance plays a significant role in monitoring the safety and performance of the modified devices. This ongoing process involves collecting and analysing data from users and healthcare professionals to identify any potential issues that may arise after a device has been modified. With strong surveillance practices in place, manufacturers can quickly address safety concerns and keep their devices aligned with regulatory standards throughout their life cycles. If required, a field safety notice (FSN) may be issued.
Managing changes to registered medical devices is a complex but vital process that involves various steps, including understanding regulatory demands, conducting risk assessments, maintaining detailed documentation, and ensuring effective post-market surveillance. By following these guidelines, manufacturers can successfully navigate the intricacies of device registration, modifications, and even pharma market access.
For expert assistance with navigating these challenges and ensuring compliance, turn to The Reg Consultants. We provide customised regulatory affairs services tailored to your unique requirements.
Reach out to us today to find out how we can assist you!
If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!