The Health Sciences Authority (HSA), Singapore`s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The latest version of the document has was in May 2021. The present document constitutes a draft version of the guidance and is intended to initiate public consultation on the matter. The HSA encourages all parties involved in operations with medical devices to provide their feedback.
Table of Contents
Regulatory Background
The authority acknowledges that at the moment, there is no efficient system used in the country for the purpose of tracking the marketing and use of medical devices. In this context, the HSA finds it necessary to introduce the appropriate system to track medical devices placed on the market in order to ensure the effectiveness of recalls and other special regulatory measures taken in response to adverse events and other incidents associated with medical devices to reduce the potential harm associated thereto.
The present guidance outlines the main aspects related to the future regulatory framework for Unique Device Identification and how the appropriate information should be submitted to the national databases: the Singapore Medical Device Register (SMDR) and Class A Medical Device Database. The authority also mentions that the document should be considered in connection with other guidelines issued by the HSA.
First, the document provides the definitions of the most important terms and concepts used in the context of a unique device identification system, including the following:
- Automatic identification and data capture (AIDC) – a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics, and RFID.
- Human readable interpretation (HRI) – a legible interpretation of the data characters encoded in the UDI Carrier.
- Registrant – in relation to a registered health product, means the person who applied for and obtained the registration of the health product under this Act.
Apart from those mentioned above, the document provides the definitions of such terms as “Clinical research,” “Custom-made medical device,” “Manufacture,” and “Product owner.”
UDI System: Key Points
According to the HSA guidance, the country will implement an international system dedicated to the tracking and identification of medical devices. The authority explicitly states that the fundamental elements of UDI system in Singapore are aligned to the internationally harmonized principles published by the International Medical Device Regulators Forum (IMDRF), which is a voluntary association of national regulating authorities in the sphere of medical devices collaborating on improvement of the regulatory framework in order to ensure the safety and effectiveness of medical devices.
The HSA expects that the implementation of the UDI system will improve the protection of patients by:
- Facilitating traceability of medical devices, especially for field safety corrective actions,
- Supporting identification of medical devices through distribution and use,
- Enabling timely identification of medical devices in adverse events,
- Reducing medical errors,
- Facilitating longitudinal capture of data on medical devices.
According to the document, the new system will include the following elements:
- Creation of the special unique device identifiers (UDIs) in accordance with the applicable international standards;
- Adding the identifiers both in HRI and AIDC formats on packaging and labeling, or even on the devices themselves;
- Including UDI data elements to the appropriate database (UDI Database or UDID), which should be performed by the parties responsible for medical devices, such as medical device manufacturers or importers. Depending on the class of the medical device in question under the applicable risk-based classification, the information related to it should be uploaded either to the Class A Medical Devices database in case of Class-A medical devices, or the Singapore Medical Device Register (SMDR) in case of Class B (or higher) medical devices.
Additionally, the authority also mentions that the UDIs placed on medical devices allowed to be marketed and used in the European Union or the US will also be admissible for Singapore.
Unique Device Identifier (UDI) Format
The document further describes the requirements for the format of a unique device identifier. According to the guidance, the UDI is a numeric or alphanumeric code that comprises of two parts: UDI-Device Identifier (UDI-DI) and UDI-Production Identifier (UDI-PI).
1. A device Identifier (UDI-DI) is a code that should be assigned to the particular model of the medical device. It should remain intact as it is used to identify the model and its configuration. This element should also be used to access information about a medical device the appropriate database contains.
2. Production Identifier (UDI-PI) is a code indicating the particular unit. The information it shall contain includes serial number, lot/batch number, software version and manufacturing and/or expiration date.
Additionally, the UDI will contain data delimiters used to simplify the interpretation of the information provided in a human-readable format. It is important to mention that the particular delimiters used could depend on the agency issuing the UDI).
AIDC and HRI Form
As mentioned, the information contained in the identifier will be provided both in human-readable and machine-readable formats (such as bar codes, QR codes, or RFID). The machine-readable format improves and facilitates data processing processes, so this approach should be used first. However, if it cannot be applied, the human-readable format should be used instead. For this purpose, the information is provided in both formats simultaneously. The HSA also mentions that the medical device manufacturer shall consider how the device will be marketed and used when determining how the information should be provided.
Labeling Requirements for UDI in Singapore
The authority additionally emphasizes that the requirement to add a unique device identifier should not be treated as the one superseding any of the current regulatory requirements related to labeling. In the case of medical devices that are not intended to be marketed in Singapore, the UDI requirements could be waived. At the same time, the appropriate requirements should be applied for medical devices that require product registration and/or are authorized for supply via Special Access Route (SAR). It is also mentioned that in the case of products intended for Point of Sale (POS) distribution, the approach to the use of an identifier could be different – it is not necessary to encode the UDI-PI in a machine-readable format for the POS package.
In summary, the present document describes the suggested approach for the implementation of the unique device identification system. The HSA highlights the main aspects associated with the new tracking system and its core components.
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