The new article provides additional details regarding the main elements and components of the UDI system, including the aspects related to labeling and data elements.
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 clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by all the parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. Moreover, an alternative approach could be applied, should such an approach be in line with existing legislation.
AIDC and HIR Form of UDI
According to the guidance, the UDI on the label or on the device itself and all higher levels of device packaging must be presented in both human readable interpretation (HRI) format and Automated Identification for Data Capture (AIDC) technology forms. The latter include, inter alia, linear barcodes, two-dimensional bar codes, QR codes, and RFID. When such elements are used, the information could be automatically obtained and uploaded to the respective patient record or another system. The information in a human-readable format accompanies the one intended for automated interpretation and is usually placed nearby.
The authority provides an example of such placement:
The HSA further explains that when deciding on the way the identifiers are to be placed, the manufacturer should take into consideration the intended purpose of the device and the way it is expected to be used.
Labeling Requirements for UDI in Singapore
The scope of the guidance also covers the aspects related to labeling. In particular, the HSA explains the way identifiers should be included in labels. At the same time, the authority additionally emphasizes that the recommendations provided herein are not intended to substitute the general requirements explained in the HSA Guidance on Labeling for Medical Devices. The authority further highlights the following key points:
- In most cases, a UDI in both HRI and AIDC forms is to be placed on the package label; however, in certain cases, it will be included in the direct labeling;
- If it is not technically feasible to place a UDI on the device label, it could be placed on the higher level label, while in case the space is for an identifier in only one of the formats, the AIDC format should be used (however, in case of home-use products, both formats are mandatory);
- If the device in question is subject to registration to be allowed for marketing and use in the country, the UDI requirements should be followed as a part of the general requirements the device should comply with for the marketing approval to be granted;
- At the same time, if the device is initially intended to be exported outside of the country, and will not be made available on the domestic market, the UDI requirements could be waived;
- If the product in question will be supplied directly to end-users via the retail Point of Sale (POS), there is no need to encode Production Identifiers (PI) in AIDC on the point of sale package.
The authority also mentions that the UDIs placed in a way compliant with the European or US regulations are admissible as well.
Data Elements for USI Databases (UDIDs)
As it was mentioned before, the entire UDI system has been introduced to improve the traceability of medical devices and the overall flow of information exchange concerning the devices allowed for marketing and use in Singapore.
According to the applicable legislation, medical devices which are assigned to Class B or higher under the existing risk-based classification are subject to inclusion in the Singapore Medical Device Register (SMDR), a country’s database for medical devices; while information about Class A medical devices is to be included in a separate database. Both above mentioned databases contain key information about any medical devices that are allowed for marketing and use in Singapore including, inter alia, brand name, model identifier, intended use, and name of the product owner. Hence, only part of the information UDI usually contains is subject to inclusion in the register. The authority also mentions that UDI-PI information is not subject to inclusion in the said registers. Both above mentioned databases are also available for the general public.
The guidance further outlines specific elements to be included in each database. Some of the aspects should be described in detail, while for some of them it would be sufficient to tick the checkbox or provide a “Yes” or “No” answer.
For instance, the scope of information to be uploaded to the SMDR covers the following data elements:
- Indication of an issuing agency (a choice for the suggested options to be made);
- Indication of whether the device in question is intended to be supplied in a sterile condition;
- A detailed description of sterilization processes and procedures;
- Indication of whether the device contains latex or DEHP;
- Indication of whether the device has measuring functions;
- Details about the UDI-DI, its number;
- Clinical size;
- SaMD version number.
In the case of low-risk medical devices subject to inclusion in the Class A medical device database, the scope of information required will be limited to:
- DM DI Number;
- Indication of an issuing agency (to be selected from a drop-down list).
In summary, the present HSA guidance highlights the most important aspects related to the components of the UDI system and also outlines the key points concerning labeling requirements for UDI, such as the format of identifiers or the way they should be placed. The authority also describes the scope of UDI-related information to be included in the country’s databases for medical devices.
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