The first article describes the regulatory background for labeling requirements, provides definitions of key terms, and also highlights the main points related to the general requirements for labeling including the way the safety and use-related information should be provided.
Table of Contents
The Health Services Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to labeling medical devices. The document provides additional clarifications regarding existing regulatory requirements and highlights the most important aspects to be considered by medical device manufacturers and other parties involved. It is important to mention that provisions of the guidance are non-binding, and could be subject to changes, should it be reasonably necessary to reflect the respective changes in the applicable legislation.
Regulatory Background
The guidance provides an overview of existing regulatory requirements related to labeling for medical devices. However, the authority also mentions that in certain cases, additional requirements could be applicable as well. Under the general rule, labeling serves to communicate safety and performance-related information to users of medical devices and/or patients as well as to identify individual devices; such information may appear on the device itself, on the packaging, as instructions for use, or in a patient information leaflet.
The scope of the present HSA guidance covers both general and in vitro diagnostic medical devices.
First of all, the authority provides the definitions of the most important terms and concepts used in the context of labeling including, inter alia, the following ones:
- Label for this guidance stands for any written, printed, or graphic representation that appears on or is attached to the health product or active ingredient or any part of its packaging, and includes any information sheet or leaflet that accompanies the health product or active ingredient when it is being supplied.
- Instructions for use applies to any information its manufacturer provides to duly inform potential users regarding the way it should be used, including the intended purpose and precautions.
- Intended purpose / intended use stands for the objective intended use or purpose, as reflected in the specifications, instructions, and information provided by the product owner of the medical device.
- Product owner stands for a party responsible for designing, manufacturing, labeling, packaging, or modifying the device, and then supplying it under its name.
- A refurbished medical device has been substantially rebuilt or restored to ensure it could be used for the initial intended purpose.
- Custom-made applies to the product that:
- Is made at the request of a qualified practitioner and following the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device;
- Is intended to be used only with a particular individual; and
- Is not adapted from a mass-produced medical device.
Apart from the ones listed hereinabove, the present guidance provides definitions of such terms and concepts as “clinical investigation”, “layperson”, “performance evaluation”, “single-use device”, and “user”. The authority also mentions that all the terms that are not explicitly defined in the guidance should be used in the meaning prescribed by the applicable legislation including the Health Products Act or Health Products (Medical Devices) Regulation 2010.
General Labeling Requirements
The authority outlines the main requirements to be followed concerning labeling for medical devices intended to be placed on Singapore’s market. The general requirements the labeling should comply with include, inter alia, the following ones:
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The information necessary to identify the product and ensure its use safely and efficiently should be placed on the product itself, as long as this is feasible. In order cases, it could be fully or partially provided on the individual package of a medical device and other packaging levels. If the aforementioned approach could not be applied, such information should be included in the instructions for use supplied together with the product in the form of a leaflet or manual.
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The way the information is provided should be appropriate in the context of the product in question, the way it should be used, and also the potential users (their experience and knowledge). This means that the instructions for use should be provided in a way ensuring they will be understandable for the intended users. In certain cases, it makes sense to provide information addressed to laypersons and healthcare professionals separately.
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For some of the low or moderate risk devices, the instructions for use are either not needed entirely, or could be provided in an abbreviated form, provided that such products could be used by intended users without additional instructions.
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By default, any product should be accompanied by the paper version of all labeling materials.
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If the product in question constitutes medical software, instructions for use could be provided in electronic format on the respective media.
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The choice of the way to provide instructions for use is also available for the manufacturer in case of medical devices that are not intended to be offered to the general public.
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Should the manufacturer decide to provide the instructions for use in non-paper format, it is important to ensure it is understandable how to access them.
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Should the information about the device be made available via the internet, the manufacturer shall ensure such information matches the one provided in paper form, while paper versions should be always accessible upon request.
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Residual risks which are required to be communicated to the user and/or another person should be included as limitations, contradictions, precautions, or warnings in the labeling.
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To ensure the information will be interpreted accurately, medical device manufacturers are encouraged to use internationally recognized symbols, especially concerning safety-related matters. Any new symbols introduced should be properly explained.
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The most important information should be provided in a human-readable format, while it could be also accompanied by machine-readable elements providing access to the same and/or additional information.
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All the information should be printed in a way ensuring it is visible and understandable.
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The language to be used for labeling should be English.
In summary, the present HSA guidance provides an overview of existing regulatory requirements in the sphere of labeling for medical devices as set forth by current legislation. The document provides the definitions of the most important terms and concepts used in the context of labeling, and also briefly described the main requirements to be followed to ensure that all the important information is duly communicated to users of the device.
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