The new article describes the implementation process related to changes to registered medical devices.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to change notification to registered medical devices. The document provides additional clarifications regarding the regulatory requirements related to changes to medical devices allowed for marketing and use in the countries, as well as recommendations to be considered by medical device manufacturers 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. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to the actual implementation of the changes to medical devices.
Regulatory Background
First of all, the authority additionally emphasizes that changes to the registered devices may be implemented upon approval of the respective Change Notification applications by the Authority. The authority further explains that once the respective application has been approved, a party responsible for a medical device is allowed to supply both the initial and modified versions of the product in question, provided both versions are compliant with the Essential Requirements for Safety and Performance for medical devices as set forth under the existing regulatory framework.
Furthermore, a party responsible for a medical device is obliged to take all the measures necessary to ensure the initial and new versions of a medical device could be easily distinguished from each other. For instance, this could be ensured by the device of batch/ lot/ serial under and manufacturing date. Apart from this, it is also important to sustain compliance with the applicable regulatory requirements in terms of record-keeping, as this allows to ensure traceability together with the effectiveness of potential corrective actions the party responsible for a medical device may need to initiate to ensure public health protection and safety of patients in case of any issues identified, while the distribution records should be provided to the authority upon request.
At the same time, the above mentioned approach when both the initial and modified medical devices are supplied simultaneously cannot be applied in case the changes are implemented in response to an Adverse Event (AE) or the course of Field Safety Corrective Actions (FSCAs) since such changes usually impact the safety, quality and/or effectiveness of the product in question, so the supply should be agreed with the HSA in the context of respective adverse events or corrective actions.
The authority also describes a situation when there are changes to the medical device labeling due to changes to the product owner. In such a case, the parties involved would have to inform the authority about the inventory stock available and the timeframe within which the old devices are expected to be fully substituted by the new ones. Furthermore, it is important to ensure that all the parties exposed (e.g., users of medical devices) are duly notified of the changes to the product owner to be able to get in touch in case of any issues with the products supplied, especially during the interim period. Under the general rule, concurrent supply is allowed for a specific period to be agreed upon with the authority while ensuring that all the respective documents are duly provided by the parties involved.
Another situation described in the guidance relates to changes to the manufacturing or sterilization site. In such a case, concurrent supply could also take place, provided the authority is duly informed about the timelines for the product replacement. In this respect, the authority additionally emphasizes the importance of ensuring that the old manufacturing site holds a valid QMS certificate within the whole interim period.
Change Notification Turn-Around-Time (TAT)
The document also highlights the key points related to the change notification turn-around time (TAT). Under the general rule, a party intended to submit a Change Notification application is responsible for ensuring its completeness before submitting, and also responding to additional requests promptly to avoid undue delays in the review process. According to the guidance, the turn-around time depends on risk classification, and also the type of change notification (i.e, review changes, administrative changes, technical changes). In particular, the turn-around time would constitute:
- For Class B medical devices, 45 business days for review changes and 30 for administrative changes;
- For Class C medical devices, 30 business days for administrative changes and 75 for technical ones; and
- For Class D medical devices, 30 business days for administrative changes and 90 for technical ones.
The authority also mentions that in case a Class D medical device in question incorporates a medicinal product subject to registration, additional consultation with the authority will be required.
Under the general rule, the calculation of the turn-around time should commence from the date the application was initially submitted. The HSA additionally emphasizes that additional requests do not trigger a stop-clock time for the applicant to provide additional information or clarifications. When deciding on the timeline to be applied, the highest applicable change category should be considered in case when multiple changes are covered by the scope of a single Change Notification application. In the case of several applications, the turn-around time should be applied to each of them on a per-application basis.
Change Notification Fees
The guidance also provides a reference to a special page indicating the fees payable by the applicants in the context of Change Notifications. According to the guidance, all the application fees are non-refundable.
In summary, the present HSA guidance highlights specific aspects associated with the change notification applications and implementation of the underlying changes. The document outlines the key points to be considered by medical device manufacturers to ensure compliance with the applicable regulatory requirements.
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