The new article highlights the aspects related to the commencement of corrective actions and the appropriate notification requirements.
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 field safety corrective actions (FSCA) to be taken with respect to medical devices in order to address safety concerns and ensure public health protection. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the document, should it be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers various aspects related to adverse events, notification obligations, and actions to be taken in order to make sure the newly identified safety concerns are properly mitigated.
The Subject of Notification Obligations
First of all, the document describes the concept of a reporting person, which stands for a party performing its reporting obligations. According to the guidance, it could be an entity involved in manufacturing, importing, supplying medical devices, or applying for marking approval. As further explained by the HSA, in cases, where more than one dealer has manufactured, imported, or supplied the affected devices in Singapore, each dealer that manufactured, imported, or supplied the affected devices may be required to report individually. At the same time, the authority mentions that in situations when complete information could be obtained from one or several reporting persons, the authority will not request it from each of the parties involved.
FSCA Initiation
The document further describes the approach to be applied when initiating the FSCA. First of all, the authority emphasizes that once the appropriate decision has been taken by the responsible person, the actual implementation of the said actions should not be delayed.
Under the general rule, before initiating the FSCA in the country, a party responsible for the medical device in question should notify the authority, and only then proceed with the actions unless instructed otherwise. The authority explicitly states that any approval from the HSA is not required in order to commence the actions, as long as the appropriate notification has been duly submitted to the authority. At the same time, the latter may require changes to the FSCA risk communication or strategy to be implemented, however, this should not prevent the party responsible for a medical device to issue a communication to all the parties involved – should the said changes be requested by the authority, they should be communicated additionally by the virtue of a separate notice.
According to the guidance, the commencement of actions described in the Field Safety Notice (FSN) constitutes the initiation of the FSCA.
Reporting Timelines
The document also outlines the reporting timelines to be followed by all the parties involved in operations with medical devices in terms of field safety corrective actions. In accordance with the applicable regulatory requirements, FSCA that falls under MDRR3 reporting should be submitted within 30 days of the initiation in any country globally, while the FSCA MDRR1 Notification Report should be submitted before the initiation of FSCA or stock recovering in Singapore. As it was mentioned before, corrective actions should be initiated without undue delay, especially in situations when they have been already initiated in other countries. The authority mentions that it will issue an acknowledgment notice once the FSCA Notification Report is received.
According to the timelines described in the guidance, a Preliminary report, if requested by the Authority, shall be submitted within 24 hours after the commencement of the FSCA; while a Follow-up or Final report is to be submitted to the Authority within 21 days from the date of commencement of the FSCA.
FSCA Reporting: Details
The document also provides additional clarifications regarding the way FSCA should be reported. According to the guidance, the appropriate report should be submitted via the Online Safety, Compliance Application and Registration (OSCAR) System. The guidance further describes specific procedures to be followed when submitting a report. In particular, the steps to be taken and the respective timeframes would depend on the regulatory status of the medical device in question. For instance, with respect to medical devices already manufactured or supplied in the country, the following requirements apply:
- The initial notification should be submitted to the authority even if some of the information is missing and expected to be available at a later stage;
- Once the FSCA is initiated, a Final Report should be submitted within 21 days;
- Should the corrective actions be not completed within the aforementioned period, a follow-up report should be duly submitted at the 21st-day mark.
Should the FSCA be related to medical devices that have not yet been supplied in the country, the appropriate report should be submitted within 30 days from the date the respective actions have been initiated in any country.
The document also provides a flowchart illustrating the approach described hereabove. It is also stated that the HSA may reject the report, should it be submitted in a way or form, different from the ones prescribed by the applicable regulations.
In summary, the present HSA guidance describes in detail the way the field safety corrective actions should be initiated, as well as corresponding reporting requirements. The document also outlines the applicable reporting timelines to be followed by the parties responsible for medical devices in order to comply with their obligations.
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