The new article highlights the aspects related to the content of reports to be submitted by the parties involved at different stages of the process.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the field safety corrective actions (FSCA) to be taken with respect to medical devices allowed for marketing and use in the country in order to ensure their continued safety and public health protection. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the recommendations provided in the document, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the matters related to the information to be included in FSCA reports to be submitted by the parties responsible for medical devices. According to the guidance, once the need for corrective actions has been identified, a party responsible for a medical device should ensure it has all the necessary information on the matter. Even though the authority acknowledges that some of the information might not be immediately available, it should be provided without undue delay.
MDRR1 Notification or Preliminary Report
First of all, the authority outlines the scope of information to be included in preliminary reports to be submitted after the commencement of the corrective actions. According to the guidance, the initial submission should contain the following details:
- Reason for the FSCA;
- FSCA strategy (if the affected stock has been supplied in Singapore);
- Product owner’s Health Hazard Assessment (HHA);
- Product owner’s Root Cause Analysis (RCA);
- Product owner’s CAPA to reduce likelihood of recurrence of device issue;
- Product owner’s CAPA effectiveness/validation;
- Affected device status (e.g., the list of devices affected and their quantity);
- Product owner’s FSN or other risk communication documents;
- A draft “Dear Healthcare Professional” Letter (DHCPL) or print advertisement (if applicable).
As further explained by the HSA, the root cause analysis should provide detailed enough technical information with respect to the root cause identified, and also describe the approach to be applied when identifying the affected devices. Corrective and preventive actions taken by a party responsible for a medical device should correspond to the root cause. Information about all the abovementioned matters should be duly provided to the authority without unreasonable delay.
If the affected device is not supplied in the country, this should be clearly indicated in the report.
The authority additionally emphasizes that providing information that is false or misleading constitutes a serious offense and could result into actions taken against the party responsible for a medical device.
Once the authority will review the initial report provided, it may provide additional instructions to be followed by the party undertaking CAPA by issuing the appropriate notice. According to the guidance, these actions may include:
- Perform an inspection of affected devices supplied in Singapore and to revert with an inspection report;
- Modify/amend risk communication on FSCA;
- Label existing supplied stock with information specified by the Authority; or
- Publish risk communication in specified media.
It is further stated that failure to comply with the said requirements would constitute an offense under the Health Products Act.
Final and Follow-Up Reports
The document further outlines the scope of information to be included in final or follow-up reports. Under the general rule, a final report should be submitted within 21 days from the date the FSCA has commenced. Should it appear that the FSCA has not been completed within the said period, a follow-up report should be submitted to update the authority on the progress, containing the information available at the stage.
According to the guidance, the authority expects the following details to be included in a follow-up or final report:
- Product owner’s CAPA to reduce likelihood of recurrence of device issue;
- Product owner’s CAPA effectiveness/validation;
- For recalls, destructions certificates or airway or shipment bills of returned of recalled devices to the product owner;
- Declaration letter from the dealer on dealer’s letterhead stating the completion of field correction for affected consignees in Singapore;
- Consignee acknowledgment receipts confirming the receipt of the Field Safety Notice or DHCPL by the local affected consignees;
- For FSCAs that require a software upgrade or device modification, service reports for the completion of the corrective actions specified in the FSN or other risk communication documents.
The authority additionally emphasizes that in order to meet the formal requirements, consignee acknowledgment receipts and service reports should be duly signed by the respective consignees, otherwise they would not be accepted by the authority. At the same time, in the case of foreign consignees, such an acknowledgment will not be required.
It is also stated that the authority may request additional information to be provided by a party responsible for a medical device with respect to the actions taken in order to mitigate the risks identified and ensure public health protection.
MDRR3 Notification Report and Identification of Affected Device
Apart from the aspects described hereabove, the document also provides additional clarifications regarding the scope of information to be included in the MDRR3 Notification Report. According to the guidance, the said report should contain the FSN, as well as the details about the number of medical devices imported but not supplied.
The document also outlines the scope of identifying information to be included in a Field Safety Notice with respect to a medical device affected.
In summary, the present HSA guidance describes in detail the information the authority expects to be included in different reports and notices associated with the FSCAs to be taken by the parties responsible for medical devices when such actions are reasonably necessary to ensure the public health protection and safety of patients. The document outlines the key elements to be covered and provides additional recommendations to be followed.
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