As of April 18, Singapore’s Health Sciences Authority (HSA) will adopt a new approach — by introducing a risk management process — for deciding whether the supply of medical devices can be continued if they are affected by an ongoing field safety corrective action. Before this approach was introduced, the interim supply of such devices was approved on a case-by-case basis. The HSA has revised its Guidance on Medical Device Field Safety Corrective Action (the Guidance) to provide further information on this approach.
The Risk Management Process
A field safety corrective action (FSCA) is required when the product owner of a medical device takes action to eliminate or reduce the risk of hazards identified. An FSCA may be triggered when the owner’s postmarket surveillance reveals an unacceptable increase in the medical device’s risk. The HSA may also, when necessary, order the implementation of a FSCA due to a device’s risk of serious injury or death to patients. Based on the corrective action intended, FSCAs can be divided into two categories: recalls and other corrective actions. Companies should ensure that recalled devices are quarantined or disposed, and not permitted for further supply.
FSCAs that fall under the category of “other corrective actions” are divided into two subcategories: corrections limited to labeling and corrections not limited to labeling. The HSA noted in the Guidance that changes in indication or shelf life will fall under the latter subcategory.
With respect to medical devices affected by corrections limited to labeling (e.g., updating the label with new user warnings), new supply will be permitted, provided that such supply is accompanied by the product owner’s field safety notice (FSN), which is a notice the owners send to device users in relation to the FSCA.
For corrective actions not limited to labeling, there are two further subcategories: correction-in-progress devices and corrected devices.
New supply of correction-in-progress medical devices is permitted if the product owner or dealer is able to provide substantiation to the HSA’s satisfaction as to how the interim risk mitigation measures taken for the device are sufficient. However, permission for such new supply may be subject to conditions, e.g., providing a declaration confirming that full correction has been completed before the end of the FSCA and requiring an FSN to be provided to each local consignee prior to supply.