The article highlights the key points related to Singapore’s unique device identification system.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature and should not be construed as the ones introducing new rules or imposing new requirements. The authority also reserves the right to make changes to the recommendations provided herein, should it be reasonably necessary to reflect the corresponding changes to the respective regulations. The HSA also encourages medical device manufacturers and other parties involved to consult with professional advisors concerning actions they are going to take. The present document constitutes the second revision of guidance initially published in August 2021.
First of all, the authority acknowledges that there is no standardized identification code or a system in Singapore to track and identify the distribution and use of medical devices through the supply chain and in the healthcare system; therefore, a harmonized identification system is necessary to improve the traceability of medical devices to facilitate timely identification of specific medical devices and patients treated with medical devices impacted by recalls, device failures or serious adverse events.
The present document provides additional clarifications regarding the way the UDI system should be implemented and respective information to be provided for inclusion into the Singapore Medical Device Register (SMDR), a country’s main database containing information about medical devices allowed to be marketed and used. The authority also mentions that the information regarding low-risk medical devices should be submitted to the Class A Medical Device Database. It is further stated that the present guidance should be interpreted in conjunction with other guidance documents published by the HSA.
The guidance also provides definitions of the most important terms and concepts used in the context of the UDI system, apart from the ones that are already provided in the applicable legislation: the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010. The definitions described in the guidance include, inter alia, the following ones:
- Automatic identification and data capture (AIDC) – is a technology used to automatically capture data and includes bar codes, smart cards, biometrics, and RFID.
- Direct-marking device identifier (DM-DI) – direct marking is placing the UDI and, potentially the full UDI carrier, permanently on the device.
- Human readable interpretation (HRI) – a legible interpretation of the data characters encoded in the UDI Carrier.
- Standalone mobile application – software and/or mobile application that is intended to function by itself and is not intended for use to control or affect the operation of other hardware medical devices (this definition is provided in the Regulation).
Apart from the ones listed hereinabove, the guidance provides definitions of such terms as “clinical research”, “custom-made medical device”, “manufacture”, “product owner”, “registrant”, and “standalone mobile application”.
UDI System: Key Points
According to the guidance, Singapore is going to implement the UDI system intended to ensure the tracking and identification of medical devices allowed for marketing and use in the country. The said system will be implemented by the principles outlined by the International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authorities collaborating for further improvement of the medical devices’ regulatory framework. As further explained by the HSA, the new system is intended to improve the safety of patients, as well as the overall effectiveness of the regulatory procedures by:
- Facilitating traceability of medical devices, especially for field safety corrective actions;
- Supporting identification of medical devices through distribution and use;
- Reducing medical errors;
- Facilitating longitudinal capture of data on medical devices.
As it was mentioned before, the actual implementation of the UDI system will take place in line with the general principles developed by the IMDRF. According to these principles, the UDI system includes:
- Development of unique device identifiers (UDIs) based on globally harmonized standards;
- Placement of UDIs in human readable interpretation (HRI) and Automated Identification for Data Capture (AIDC) formats on device package labels of the smallest unit of supply and all higher levels of packaging or in some cases directly marked on the devices;
- Submission of minimum additional necessary UDI data elements such as UDI-DI to UDI Databases (UDID) by registrants, local manufacturers, and importers. In the case of Singapore, the UDIDs will be the Singapore Medical Device Register (SMDR) for medical devices with risk Class. B or higher and Class A Medical Devices database for Class A medical devices.
The document further describes in detail the format of a Unique Device Identifier and the elements it is composed of. According to the guidance, an identifier constitutes a numeric or alphanumeric code and includes two components:
- UDI-Device Identifier (UDI-DI), and
- UDI-Product Identifier (UDI-PI).
As further explained by the HSA, the first component is model-specific and provides information about the product itself, including the particular model, as well as about the medical device manufacturer and package configuration. This element is also intended to be used to access other information related to the product, which is stored in the UDI database. The second component is intended to provide information about the specific device, including such details as serial number, lot/batch number, software version, and manufacturing and/or expiration date (as applicable). Apart from the said components, an identifier also contains data delimiters – special elements intended to make it easier to interpret the information provided.
In summary, the present guidance provides an overview of the unique device identification system to be implemented in Singapore. The document also provides definitions of the most important terms and concepts used in the context of the UDI system.
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