Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what the risk of the change may be. As a result, there may be duplication of efforts which delay change approval times, innovations being bogged down, and poor usage of regulatory resources.
The paper explores regulatory changes affecting devices, IVDs, and SaMDs. While most Western countries, such as Canada, the EU, and the US, follow a risk-based flow approach for significant changes, many Asian countries instead adopt a list-based categorization strategy. The paper also discusses how approaches to consolidating changes differ across health authorities. For instance, some Asian countries may permit bundled submissions for similar changes across multiple products, while others require a product-by-product approach. It further examines time-to-market implications, transition periods, and post-approval change management protocols. Finally, the paper promotes a risk-based change management system and increased change management harmonization for devices in Asia. For more details, please click here.