The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices allowed for marketing and use in Singapore.
Table of Contents
The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document on complaint handling of medical devices. The document provides an overview of the regulatory requirements set forth under the existing framework, as well as additional clarifications and 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 guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. Furthermore, the authority encourages the parties involved to obtain case-specific advice on the way the applicable regulatory requirements should be followed since the recommendations provided in the guidance are non-exhaustive and do not address all possible situations.
Regulatory Background
First of all, the authority emphasizes the importance of ensuring the effectiveness of a complaint handling system being a part of a quality system. Under the general rule, any complaint received with respect to a medical device allowed for marketing and use in Singapore should be subject to rigorous evaluation and investigation, based on which the appropriate corrective actions should be taken in order to ensure proper operations of the device, as well as the safety of patients. The authority also mentions that the results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences.
In accordance with the existing regulatory requirements for complaints handling, all the parties involved in operations with medical devices (including medical device manufacturers, importers, wholesalers, and registrants) are obliged to:
- Maintain records of complaint reports and of actions taken in response to these reports, and produce such records for inspection by the authority or an enforcement officer as and when required; and
- Establish and implement documented procedures to conduct effective and timely investigations of reported problems.
Thus, recommendations provided in the present HSA guidance would be applicable to any party involved in placing medical devices on the country’s market.
The Health Products (Medical Devices) Regulations (Regulations) establish the mandatory reporting timelines to be followed when reporting serious adverse events associated with medical devices. In this respect, the authority also refers to the respective guidance document dedicated to reporting adverse events for medical devices which describes in detail the applicable regulatory requirements and provides additional recommendations to be followed to ensure compliance thereto.
Terms and Definitions
In order to assist the parties involved in interpreting the provisions of the existing regulations, the document also provides definitions of the most important terms and concepts used in the context of complaints handling processes and procedures.
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- Customer complaint stands for any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, or performance of a medical device that has been placed on the market;
- Product owner, as defined in the Regulations, stands for a person who:
- Supplies the health product under his own name, or under any trademark, design, trade name, or other name or mark owned or controlled by him; and
- Is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying the health product, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf.
Record-Keeping Requirements
As it was mentioned before, the existing regulatory framework establishes record-keeping requirements all the parties involved should fulfill in order to ensure traceability and proper processing of information related to adverse events associated with medical devices. The guidance further outlines the scope of information to be recorded with respect to each complaint. According to the document, such information should include:
- Details about the device itself, including its brand name, the applicable license number, as well as other numbers or elements that could be used to identify the affected device;
- Details about the medical device manufacturer and other parties involved in the supply of the affected device on the market;
- Issue-specific records describing the incident itself.
Moreover, in accordance with the existing record-keeping requirements, any and all actions taken by the parties involved with respect to a medical device based on a corresponding complaint should be duly documented. This applies to any communications with other parties, evaluation/investigation conducted, and any actions taken in order to address the issue identified. According to the guidance, such steps might include increased post-market surveillance of the medical device, corrective and preventive action with respect to the design and manufacture of the medical device, or product recall.
The authority additionally emphasizes the importance of continuous analysis of incident-related records as a way of identifying trends in problems associated with medical devices. Each of the incident reports should be evaluated not only separately, but also in connection to other similar cases.
In summary, the present HSA guidance provides an overview of the regulatory requirements for complaints handling as set forth under the existing framework. The document outlines the key points to be considered by medical device manufacturers and other parties involved when receiving complaints and taking action.
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