The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field safety corrective actions, and also the ones that are not subject to change notification requirements.
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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 the change notification requirements. The document explains in detail the way medical device manufacturers should notify the authority about the changes to medical devices they are responsible for. In particular, the guidance describes the approach to be applied when submitting a change notification related to a medical device already placed on the market and outlines the requirements such notification should meet depending on the device itself, as well as on the nature of the changes and risks associated thereto. It is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications for the existing regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The document describes, inter alia, different types of changes to medical devices, and also explains the way such changes should be treated, and the requirements to be applied.
Changes to Medical Devices due to an AE and/or FSCA
The HSA pays special attention to the changes related to an adverse event (AE) or the ones implemented in the course of field safety corrective actions (FSCA). Due to the nature of such changes, they are initially intended to impact the safety, quality, and/or efficacy of the product, hence, require additional attention.
According to the guidance, the documents and information to be submitted by a responsible party concerning such changes include, inter alia, the following ones:
- Product owner’s Field Safety Notice (FSN) or Dear Healthcare Professional Letter (DHCPL) and/or other risk communication documents;
- Product owner’s Health Hazard Evaluation (HHE);
- Product owner’s Root Cause Analysis (RCA);
- Product owner’s Corrective and Preventive Action (CAPA) to reduce the likelihood of recurrence of device issue;
- The product owner’s CAPA effectiveness/ validation.
The authority also mentions that since the above documents are also to be submitted in the course of FSCA reporting, there is no need to submit them separately in the context of change notification in case there were no changes to them. In such a case, when submitting a change notification, a responsible party should indicate the FSCA reference number. However, in case some of the documents outlined hereinabove are still to be provided, the authority may issue the appropriate request, and also request any additional information it finds necessary to assess the case.
According to the guidance, the particular requirements to be applied concerning a change notification related to a reportable adverse event or field safety corrective action should be determined based on the respective type of change.
The HSA additionally emphasizes that the changes related to AEs or FSCAs are subject to prior approval before being implemented. The said approach should be applied to all medical devices placed on the market irrespective of the change category. However, the said requirement could be waived based on the appropriate written advice issued by the HSA.
Changes That do not Require Submission on Change Notification
The document also describes the situations when a change notification is not required. According to the guidance, the changes that do not require change notification include, inter alia, the following ones:
- Labeling changes that only involve changes in layout, color, font sizes, and design, without change in prominence of precautions, warnings, contraindications, and/or adverse events;
- Labeling changes that involve the addition and/or removal of languages not required by the authority;
- Labeling changes that involve the addition/removal of reference agency approvals;
- Labeling changes that involve the update of distributor information, including EU authorized representatives, and which do not affect the device listing information;
- Labeling changes that involve the addition/change or removal of barcodes, and which do not change the device listing information;
- Labeling changes that involve the addition of a Unique Device Identifier (UDI), and which does not change the device listing information;
- Change involves only a design change that does not affect performance characteristics and/or specifications of the medical device (e.g., changes that improve ergonomics, and aesthetic modifications).
The authority also explains that the approach described herein could be applied concerning changes to the date format in labeling, as well as raw material supplier changes (as long as such changes do not impact the specifications of a medical device already placed on the market). Apart from the above, change notification is not required for changes to the QMS certification, provided such changes are not related to the device itself, and also the changes to the certification body involved, in case the QMS certificate remains unchanged.
In summary, the present HSA guidance highlights the key points related to a specific category of changes – the ones associated with the reportable adverse events and field safety corrective actions. The document also outlines the scope of changes for which change notification is not required since the changes are not expected to impact the safety, quality, and efficacy of a medical device registered and allowed for marketing and use.
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