The new article addresses the requirements to be applied in specific cases, such as:
Medical devices incorporating or administering medicinal or biological substance;
Implantable medical devices;
Medical devices intended to emit radiation;
In-vitro diagnostic 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 existing regulatory framework, and also to assist medical device manufacturers in ensuring compliance thereto. The scope of the guidance covers general regulatory requirements, as well as device-specific rules to be followed.
Medical Devices Incorporating or Administering Medicinal or Biological Substance
According to the applicable regulations, in case a medical device contains or incorporates a medicinal or biological substance, the appropriate indication should be included in its labeling. Moreover, the information to be included in such an indication should be sufficient to ensure proper identification of the particular substance. Apart from this, the manufacturer should provide complete information about any safety-related warnings and precautions, as well as applicable limitations for use.
In case the device itself does not incorporate any substance but is intended to administer such products, the information to be provided by the manufacturer should include the details about the products compatible with the device, the way such products should be selected, and also compatibility criteria, if applicable.
Another section of the guidance covers the aspects related to the labeling requirements for implantable medical devices. First of all, the authority emphasizes the importance of including information about the risks associated with the implantation of the product. It is also stated that for active implantable medical devices, the device shall display a code that can be used to identify the type of medical device, the product owner of the medical device, and the year of manufacture of the medical device. The said code should be provided in a way ensuring it is readable even upon implantation of the device – for instance, via the use of radio-opaque symbols.
The scope of the document also describes the requirements to be applied in the case of medical devices intended to emit radiation. For this type of product, the scope of information to be included in the labeling should cover the nature, type, intensity, distribution of this radiation, and the means of protecting the patient and user from unintended radiation during the use of the device.
According to the guidance, special rules should be also applied in the case of medical devices intended for in vitro diagnostic (IVD) use. For instance, it is necessary to ensure the information includes an explicit indication of the intended use of a product. The authority further explains that the information about the intended purpose should include, inter alia, the following details:
- Type of analyte or measurand of the assay;
- Whether the test is quantitative or qualitative;
- Role of the test in the clinical use e.g. screening, diagnostic or detection, aid to diagnostic, monitoring;
- The specific disorder, condition, or risk factor of interest that it is intended to detect, define or differentiate;
- Type of specimen to be used;
- Patient population the IVDD [in vitro diagnostic device] is to be used in;
- The intended users (e.g. self-testing by layperson, near-patient by trained personnel or professionals);
- The specific name of instrument required for the assay, if any;
- The intended use should also include the modes of operation for instruments (e.g., random access, batch, stat, open tube, closed tube, automatic, manual).
Apart from the details listed hereinabove, the labeling for in vitro diagnostic medical devices should include sufficient information about such aspects as:
- The underlying principle of operations;
- The way specimen should be collected to ensure proper performance of the device, as well as accuracy and reliability of test results;
- Elements, components, and accessories, such as reagents or calibrators, and the way they should be used;
- Reference materials to be used for calibration purposes;
- The process of using the device, and also the way the results should be interpreted;
- A list of materials provided and a list of special materials required but not provided;
- Cautions regarding the hazardous materials the product contain;
- Quality control procedure and the way it should be performed;
- Requirements regarding storage conditions to be followed to ensure the device remains operational, as well as the indication of a product’s shelf life upon opening the packaging;
- Indications on the way performance of the product should be evaluated (including information on interfering substances or limitations, analytical performance characteristics, as well as clinical performance characteristics and clinical study design). This covers sensitivity, specificity, and accuracy.
In summary, the present guidance document addresses the most important aspects related to the labeling requirements for medical devices and provides recommendations to be taken into consideration by medical device manufacturers to ensure compliance thereto. The document outlines the scope of information to be included in the labeling depending on a medical device, its intended use, and risks associated thereto. It is important to mention that the guidance issued by the HSA contains references to similar guidance documents issued by Health Canada, the Canadian regulating authority in the sphere of medical devices. As explained by the regulatory agency, the information accompanying the device should be sufficient to ensure the safe and efficient use of the product for its intended purpose and in the appropriate environment. Hence, an entity responsible for labeling should ensure all necessary information including warnings, cautions, and contradictions are duly communicated to intended users by the virtue of labels placed on the device itself, it is packaging, or documentation supplied together with the device.
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