The new article describes in detail the way the new unique device identification system will be implemented in Singapore. In particular, the article addresses the matters related to the development and placement of identifiers.
The Health Sciences Authority (HSA), a country’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 provides an overview of the applicable regulatory requirements, as well as additional recommendations to be considered by all the parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and could be subject to changes, should such changes be reasonably necessary to reflect the respective amendments to the underlying legislation.
Developing and Placing the UDI: Key Points
According to the applicable regulatory requirements, manufacturers or product owners are responsible for accurately assigning and placing the UDI in HRI and AIDC formats on the device label or on the device itself, and all higher levels of the device package level hierarchy following the issuing agency’s specifications. The authority further explains in detail the requirements to be applied depending on whether the product in question is allowed for marketing and use in the USA and/or European Union. If the product is allowed for marketing in those regions, the initial identifier could be used in Singapore as well. The information about Class B, C, and D devices should be submitted for inclusion in Singapore’s Medical Device Register (SMDR), while the information related to Class A medical devices should be included in the respective database for low-risk products. At the same time, in case the product is not approved for marketing in the US or EU, the party responsible for such product would have to develop and implement the identifiers by the national regulatory requirements. In particular, it will be necessary to choose an issuing agency from the list of agencies approved by the HSA and assign the appropriate identifier to a medical device by the recommendations provided in the present guidance.
The scope of the guidance covers, inter alia, the aspects related to:
- Designated issuing agency in Singapore;
- Implementing UDI-DI triggers, that should be in a consistent manner that promotes UDI as a global standard for device identification;
- Direct marking on medical devices.
Issuing Agency (IA)
The document further provides additional information about issuing agencies and their role in the processes related to the unique device identification system. As explained by the authority, an issuing agency is an organization designated by HSA to operate a system for the issuance of UDIs for regulatory purposes. The list of issuing agencies includes, inter alia, such organizations as GS1, the Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA). All the above mentioned organizations are approved by the HSA and could be referred to when assigning UDIs to medical devices intended to be marketed in Singapore.
According to the guidance, in order to be designated as an IA, an organization should meet the following criteria:
- Operates a system for the issuance of UDIs which conforms to the relevant international standards;
- Issue UDIs that are adequate to identify a device throughout its distribution and use;
- Makes its system for the issuance of UDIs available to all users following a set of predetermined and transparent terms and conditions;
- Undertakes to make available to HSA, upon request, any information concerning its system for the assignment of UDIs.
The authority further provides additional clarifications to be considered concerning the UDI assignment. For instance, the HSA emphasizes the importance of assigning a new UDI-DI in case of significant changes made to the device to ensure both new and initial medical devices remain easily identifiable and traceable. In such a case, a party responsible for a medical device in question would have to submit a Change Notification or a new premarket application. In this respect, the authority refers to the respective guidance on change notification for registered medical devices.
Another important aspect addressed in the guidance is direct marking, which stands for placing the UDI and, potentially the full UDI carrier, permanently on the device itself. The authority acknowledges that nowadays a wide range of technologies and solutions could be used to place identifiers directly on the device, however, the authority additionally emphasizes the importance of ensuring the identifier is placed in such a way that it remains visible and readable within the whole expected service life of the product. Hence, to ensure this, the manufacturer should take into consideration the way the device is expected to be used, and also the factors that could potentially impact the device and direct marking in particular. According to the guidance, the factors to be considered concerning direct marking shall include:
- Potential interference arising from any type of direct marking on the safety or performance/effectiveness of the device;
- The technological feasibility of direct marking on the specific device in question.
Thus, when considering the use of direct marking, the manufacturer should pay special attention to the characteristics of the technology to be applied, as well as to the way the device will operate when used for its intended purpose.
In summary, the present guidance provides additional clarifications regarding the way the identifier should be assigned and placed. The authority indicates the issuing agencies that are recognized in Singapore, and also highlights the main points to be considered concerning placing unique device identifiers directly on the device itself.
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