The new article highlights the aspects related to the form and manner of reporting, responsible parties, as well as procedures and activities associated with reporting.
The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the reporting of adverse events for medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered 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 nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. It is also stated that in case of any doubts or concerns regarding the interpretation and fulfillment of the applicable regulatory requirements, the parties involved are encouraged to obtain additional professional advice.
Adverse event reporting constitutes one of the most important measures implemented in order to ensure the continued safety of any and all medical devices allowed for marketing and use in Singapore. In general, reporting includes both mandatory reporting medical device dealers are subject to, as well as reporting by healthcare professionals using the devices, together with the exchange of information related to adverse events associated with medical devices continuously conducted by the regulating authorities. The main purpose of adverse event reporting is to ensure the timely identification of issues giving raise to actual or potential risks in order for additional actions to be taken if necessary.
Prescribed Form and Manner For Submissions
First of all, the authority states that the reports related to adverse events should be submitted by responsible parties in the form and manner prescribed by the HSA. In particular,
- Form# MDAR1 should be used in case of adverse events that are not related to clinical trials; while
- Form# CTB_MD_AE should be used for reporting adverse events that are related to clinical trials.
With respect to the latter, the authority additionally emphasizes that it should be submitted to the Clinical Trials Branch in accordance with the respective guidance document issued by the HSA.
When making a submission, a responsible party may use email, fax, or post mail. Should an email be used, the authority encourages to use of pdf for providing the form, and mentions that 2MB email size limit applies.
The authority also provides clarifications regarding the parties considered to be responsible for submitting adverse events reports. Under the general rule, all persons who register, manufacture, import and supply medical devices in Singapore are required to report YEs involving medical devices, which they have placed on the market; where a reportable AE involving medical devices placed on the market by more than one person occurs, each person involved should make a report. Hence, all the parties involved in operations with medical devices allowed to be marketed and used in the country are subject to reporting obligations set forth under the applicable legislation.
Actions and Further Steps
As explained by the HSA, once the report of an adverse event associated with a medical device is received by the authority, the party submitting a report will be notified accordingly. The report will further be reviewed by the authority and entered into a respective database allowing the authority to identify and monitor trends associated with adverse events related to medical devices placed on Singapore’s market.
In certain cases, additional actions will be required based on the information included in the report in order to ensure public health protection and the safety of patients. In particular, when reviewing adverse event reports, the authority may identify unexpected hazards or adverse effects. The actions to be taken in order to address the issues identified may include, inter alia, making changes to the instructions for use, communicating additional safety-related information to all the parties using the device, or initiating the device’s withdrawal from the market, should the risks associated thereto be found unacceptable.
In summary, the present HSA guidance provides an overview of the regulatory requirements for reporting adverse events related to medical devices as set forth under the current framework. The document outlines the scope of events subject to reporting, describes in detail the reporting thresholds, provides additional clarifications regarding the forms to be used when submitting the reports, and also highlights the key points to be taken into consideration by all the parties responsible for reporting. In particular, the scope of the guidance covers specific aspects related to general and in vitro diagnostic medical devices based on the difference in the nature and risks of these types of products, and also describes the applicable reporting timelines to be followed.
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