The article addresses the aspects related to the content of labeling for various types of medical devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the labeling requirements for medical devices. The document is intended to provide additional clarifications regarding the way the provisions of the respective legislation should be interpreted, and also recommendations to be considered by medical device manufacturers to ensure compliance thereto. However, provisions of the guidance document are non-binding, and in case of any discrepancies with provisions of the applicable legislation, the latter should prevail.
Under the general rule, any medical devices intended to be marketed and used in the country should be supplied together with all the information necessary to ensure they will be used safely and efficiently. Apart from this, the information accompanying a medical device should identify its manufacturer and other entities responsible for the product (if applicable).
The aforementioned information could be provided in the labels placed on the device itself or its packaging. These details should be also included in the instructions for use accompanying the device. The authority states that in any case the information should be communicated in a way ensuring it is available to the user. The scope of information to be provided, and the level of details to be addressed should be determined depending on the nature of the device in question, its intended purpose, and risks associated thereto.
As further explained by the HSA, the general elements to be included in labeling are:
- Name and contact details of the Product Owner,
- The trade or brand name of the medical device,
- Sufficient details for the user to identify the device,
- For devices where these are not obvious, its intended purpose, user and patient population of the device,
- An indication of either the batch code/lot number or the serial number,
- An unambiguous indication of the date until when the device may be used safely, expressed at least as the year and month,
- If the above is not applicable – an indication of the date of manufacture,
- An indication of any special storage and/or handling condition that applies,
- Date of issue or latest revision of the instructions for use,
- an indication of what the package contains, expressed in terms appropriate to the medical device,
- Any special operating instructions for the use of the medical device,
- Information on the way to identify the devices to which the device in question should be connected when used for its intended purpose,
- The information needed to verify whether the device is properly installed and can operate correctly and safely,
- The performance intended by the product owner and any undesirable side effects,
- Specifications that the user requires to use the device appropriately,
- Any requirement for special facilities, or special training, or particular qualifications,
- The circumstances when the user should consult with a healthcare professional (if the device is initially intended to be used by non-professionals having no formal qualification and experience),
- Any contra-indications, warnings, restrictions or precautions,
- Precautions related to materials incorporated into the device,
- Indications on actions to be taken in case the device are not operating as intended,
- Information about the risks arising due to the presence of the device in terms of potential interferences,
- Details about the matters related to electromagnetic compatibility.
The points listed hereinabove constitute the most important ones to be addressed in the labeling, which stands for any sources of information accompanying the device including not only the labels placed on the device itself, or its packaging, but also the instructions for use, operating manuals, and other leaflets that could be supplied with the device to communicate important use-related information to ensure the device is used safely and efficiently.
Apart from the general points addressed above, the guidance also covers certain specific cases.
Considerations for Sterile and Non-Sterile Devices
In case the medical device is supplied in a sterile condition, the appropriate indication should be made. Moreover, it is also necessary to provide information about the particular sterilization method used, in case such information is valuable to the users due to the nature of the device and its intended use. These details should be provided on the packaging of the product. Apart from this, it is also necessary to provide recommendations regarding the actions to be taken in case the packaging of the product is damaged. For instance, instructions on re-sterilization could be provided, if this is something that could be performed outside the manufacturing facility.
For the devices that are supplied non-sterile, the information could include the details on sterilization and other actions to be taken by the user before the device will be used. The HSA additionally emphasizes that should sterilization be required before use, the appropriate recommendations should be duly provided by the manufacturer. These instructions should describe in detail the particular steps to be taken to ensure the device meets the Essential Principles of Safety and Performance of Medical Devices and could be used for its intended purpose.
Considerations for Single-Use and Reusable Devices
The scope of the guidance also covers specific matters to be considered depending on the number of times the device can be used. For instance, in the case of a single-use medical device, the appropriate indication should be included in the labeling. For reusable medical devices, the manufacturer should duly provide detailed enough instructions on maintenance to take place between uses (e.g., cleaning, disinfection, packaging, and re-sterilization). Furthermore, it is also necessary to describe the way the user can identify that the device should be no longer used.
Other Specific Matters
The present HSA guidance also provides additional considerations related to the content of labeling for medical devices, such as:
- If the product in question constitutes a custom-made medical device created under the appropriate request and in line with the needs of a specific patient, this should be indicated in its labeling.
- If the device is intended to be used in clinical investigation and is not intended to be placed on the market, the appropriate indication should be added as well.
- The same approach should be applied in the case of medical devices intended for non-clinical use.
- In the case of refurbished medical devices, the appropriate indication should be included in its labeling.
In summary, the present guidance outlines the most important aspects to be considered about the content of labeling for medical devices depending on their nature and specifics. The document provides additional details regarding the safety warnings to be included to ensure that all the important information is duly communicated to the users.
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