The present article describes in detail the process of submission of unique device identification data elements via the electronic submission system. In particular, it covers the procedures for registered medical devices via the new e-service.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the unique device identification (UDI) system intended to improve the traceability of medical devices allowed to be marketed and used in the country. The document provides 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 and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective changes to the underlying legislation.
The present article addresses the aspects related to the use of the new e-service “Submission of Update of Unique Device Identifier” for updating specific data elements concerning the medical devices that are already registered. In particular, this service could be used to update a limited list of UDI data elements, namely:
- UDI-Device Identifier (UDI-DI);
- Direct Mark-Device Identifier Number (DM-DI);
- Issuing Agency (IA).
The authority also mentions that it is possible to make changes to the entries related to different medical devices at once, and such changes will be reflected properly in the system. At the same time, the HSA additionally emphasizes that updating UDI-DI, DM-DI, and IA for the registered medical devices in the device listing should not change any of the device registration information.
New e-service: Submission Process in Detail
The document further describes the submission steps and specific actions to be taken by a party responsible for a medical device to have the aforementioned information updated.
These steps include, inter alia, the following ones:
- A party responsible for the device (the registrant) should indicate specific devices to which the submission is related. As it was mentioned before, multiple devices can be indicated.
- The registrant should select specific UDI data elements to be updated, and then download a file containing all the information about the devices selected.
- Fill in the said file with the UDI-DI and DM-DI information. The authority explicitly states that changes to the details regarding the model name and number, as well as the brief device description cannot be made in such a way.
- Once completed, the file should be uploaded to the system, and the information provided should be verified.
- The registrant should also update the information about the issuing agency involved in issuing the unique device identifier used for the product in question.
As a result, the UDI-DI and DM-DI information will be updated in Singapore’s Medical Devices Registry, a country’s register for medical devices. The authority also mentions that the process described in the guidance is also explained in the appropriate video guides and additional guidelines available on the authority’s website.
Another approach to be applied to make changes to the entries related to medical devices already registered in the database is Change notification. According to the guidance, it could also be used to update UDI data elements, namely:
- Issuing agency,
- DM-DI Number (only if different from UDI-DI),
- Sterile medical device,
- Description sterile medical device: (e.g., sterilization methods),
- Device containing latex,
- Device containing DEHP,
- Device with measuring function,
- Clinical Size (including Volume, Length, Gauge, Diameter), SaMD version number /software version number.
As further explained by the HSA, this pathway could be used for making changes that do not require a Change Notification to be submitted and are falling within the scope of UDI data elements outlined hereinabove. It is also stated that the changes are to be introduced under the said procedure immediately upon receipt of an acknowledgment email from the authority.
The guidance also provides a step-by-step description of the actions to be taken by the registrant to update the UDI data related to the devices it is responsible for. As in the previous case, it will be necessary to indicate specific medical devices to which the changes are related, fill in the new details and confirm the changes. It would be also necessary to download and then upload a file with the changes. Apart from that, it will be necessary to submit additional supporting documentation including, inter alia, a signed copy of the Declaration on company letterhead by the registrant to confirm that the change notification application is only for the addition of UDI information for the models listed in the device listing and there is no change to any of the device listing information.
The authority further refers to the respective guidance on change notification for registered medical devices.
In summary, the present HSA guidance describes two approaches to be used for updating UDI-related information for medical devices that are already placed on the market and registered in the respective databases. The document outlines the scope of unique device identifier information that could be subject to changes via each of the pathways and also describes step-by-step procedures to be followed by a party responsible for a medical device in question to implement such changes. The guidance provides detailed instructions on the way the electronic submission systems should be used including, inter alia, the particular fields to be filled, and forms to be submitted.
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