The article provides an overview of Singapore’s classification system for 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 classification rules for in vitro diagnostic (IVD) medical devices. The document is intended to provide additional clarifications regarding the way IVD products should be classified, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure correct interpretation of respective legislation. However, the document is non-binding, and in case of any discrepancies with provisions of the applicable laws and regulations, the latter should prevail.
Under the general rule, regulatory controls should be proportional to the level of risk associated with an in vitro diagnostic (IVD) medical device. Hence, the higher the risk, the stricter said controls should be. Consequently, to determine the level of legal scrutiny and regulatory burden to be applied, all IVDs should be divided into categories based on the risk associated thereto. The risk itself depends mostly on the intended purpose of the product in question, as well as on the measures taken to mitigate such risk at all the stages including product design, manufacturing process, and use. The benefit/risk profile of the device is also impacted by the way the device operates (mode of operation), as well as the technologies used.
The scope of the present guidance covers any in vitro diagnostic medical devices subject to regulatory oversight under the existing framework based on the First Schedule of the Health Products Act.
First of all, the guidance provides definitions of the most important terms and concepts used in the context of the document including, inter alia, the following ones:
- Instrument – equipment or apparatus intended by the product owner to be used as IVD medical device;
- Intended purpose/intended use in the context of a medical device 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;
- IVD medical device for self-testing is a medical device intended by the product owner for use by laypersons (the latter are defined as individuals who do not have formal training in a relevant field or discipline);
- Near patient testing – any testing performed outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient (also referred to as Point-of-Care or POC testing);
- Reagent stands for any chemical, biological or immunological components, solutions, or preparations intended by the product owner to be used as IVD medical devices.
Apart from the ones listed hereinabove, the document provides definitions of such terms as “Accessory”, “Examination”, “Harm”, “Hazard”, “Product Owner”, “Risk”, “Specimen”, “Transmissible agent”, “Transmission” and others.
IVD Classification: Basics
The document further explains the ideas behind the classification rules and key underlying principles. As it was mentioned before, the main aspect to be considered in this regard is a risk associated with the device when it is used for the intended purpose. This concept covers the matters related to the indications for use, the qualification level of intended users, and also the way the information to be provided by the device will be used in the decision-making process. At the same time, the authority explicitly states that irrespectively of the applicable classification, any IVD medical devices should comply with the respective Essential Principles of Safety and Performance of Medical Devices, as well as the labeling requirements.
Classification System in Detail
According to the applicable legislation, IVD medical devices are divided into four classes as follows:
- Class A – Low individual risk and low public health risk;
- Class B – Moderate individual risk and/or low public health risk;
- Class C – High individual risk and/or moderate public health risk;
- Class D – High individual risk and high public health risk.
The guidance also provides examples of the ways different IVD medical devices should be classified according to the rules described hereinabove.
Risk Class Determination
To assist medical device manufacturers in determining the proper class to be applied, the authority provides additional clarifications regarding the way classification rules should be followed. According to the guidance, the steps to be taken include the following ones:
- Determine whether the product in question constitutes an in vitro diagnostic medical device and, consequently, is falling with the scope of IVD classification rules;
- Apply classification rules based on the intended purpose of the device and risks associated thereto, while in situations when multiple classification rules are applicable, the one prescribing the higher class should be applied;
- Document the appropriate justification for applying the particular risk class.
Apart from this, the HSA provides additional recommendations to be considered to ensure correct classification, namely:
- Standalone control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes should be placed in the same class as the IVD reagent(s);
- Standalone control materials with no assigned values intended for use with multiple or single analytes should not be placed in the same class as the IVD reagent(s);
- The software which is not incorporated into a medical device should be treated as standalone software, while in case such software meets the definition of an in vitro diagnostic medical device, it should be subject to classification under the IVD classification rules described herein.
IVD Classification Rules
The guidance further describes the applicable classification rules for in vitro diagnostic medical devices one by one, clarifies the way they should be applied, and also provides the rationale behind each of the rules. These rules describe the way the class of an IVD medical device should be determined depending on its intended purpose, indications for use, and also the risks associated with the use of the device (due to the specific nature of IVD products, the latter stands for the way the testing results device provides are intended to be used in a decision-making process, and the impact inaccurate results could have).
In summary, the present HSA guidance highlights the most important aspects to be considered by medical device manufacturers when determining the class of in vitro diagnostic medical devices. The document emphasizes the key points and describes the way classification rules should be applied depending on the specific features of the device in question.
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