The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.
Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).
The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations. Clinical investigations are necessary to assess a device’s safety and performance and demonstrate that it meets the requirements of the EU MDR. Under the EU MDR, the clinical investigation has been divided into three (03) components –
The primary distinction between a Unique Device Identifier (UDI) and a barcode in medical device labeling is that the UDI is a standardized identifying number assigned to each medical device, whereas a barcode is a graphic that can be scanned and read by a barcode reader or scanner.
It is well-known that Unique Device Identification (UDI) is critical, and if implemented accurately, it will garner major and long-term benefits for medical device manufacturers, healthcare providers, and consumers.
The US Food and Drug Administration (FDA) defines Clinical Outcome Assessment (COA) as a narration and reflection of how a person feels, functions or survives. The medical device manufacturers may opt to include Clinical Outcome Assessments (COA) in the Regulatory submissions for their device approvals such as PMA and 510(k). Well planned, structured and reported clinical outcome measures provide quality information to demonstrate benefit-risk aspects of a medical device, frame labeling communications, defining patient selection criteria for clinical studies and measurement criteria.
The Thai Food and Drug Administration (TFDA) has revised its medical device regulations to ensure the safety and effectiveness of the devices marketed in Thailand and to harmonize the regulations with the other ASEAN countries. There have been changes in the medical device classification, registration pathways and process, timelines and fees. The new regulations, which are more rigorous, came into force from February 2021 and are applicable to both medical devices and In-Vitro Diagnostic devices (IVDs).
