The article provides an overview of the regulatory framework related to the safety and performance requirements for 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 Essential Principles for Safety and Performance of medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, the document is non-binding, and could be subject to changes, should such changes be reasonably necessary to reflect the respective changes to the underlying legislation.
Essential Principles: Basics
Under the general rule, any medical devices intended to be marketed and used in Singapore should comply with the applicable Essential Principles of Safety and Performance, while the parties involved should ensure the said compliance to be allowed to undertake the respective activities. In this respect, the authority also refers to the applicable international standards addressing specific aspects. The authority additionally emphasizes that compliance to the said principles is mandatory irrespectively of the particular regulatory pathway applied when placing a device on the market, i.e., even the devices that do not require registration should comply with the Essential Principles as well.
To be deemed compliant with a standard, the medical device should comply with the respective requirements related to the safety, effectiveness, and labeling as set forth therein; and the appropriate evidence should be provided by the party responsible for the medical device in question. The said conformance could be demonstrated, inter alia, by having a quality management system duly developed and implemented following the requirements set forth by the respective standard. If the devices are supplied sterile, the appropriate sterilization procedures should be validated to ensure they meet the necessary endpoints.
As it was mentioned before, compliance with the Essential Principles is mandatory for all medical devices irrespectively of their class under the risk-based classification. However, since Class A (low-risk) medical devices are exempted from registration, it would be sufficient for their manufacturers to follow the record-keeping requirements in the context of documenting the key aspects to be able to provide the necessary information and documentation to the authority upon request. If the Class A product in question is intended to be supplied sterile, the appropriate records related to sterilization methods and procedures should be maintained as well.
It is important to mention that the existing regulatory framework does not prescribe a specific approach to be followed by medical device manufacturers to achieve and sustain compliance with the Essential Principles to provide them with additional flexibility in determining the optimal one.
According to the guidance, for purposes of medical device registration in Singapore, evidence of conformity to Essential Principles of Safety and Performance can be provided in the form of a tabular checklist with supporting documentation to demonstrate conformity. The document also provides examples of such checklists to assist medical device manufacturers in complying with the said requirements. The authority also states that the previous version of a conformity checklist is still admissible, together with the one based on the requirements set forth by the applicable regulations outlined in the European Union or by the Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare products.
The scope of the present guidance covers any medical devices intended to be marketed and used in Singapore.
Terms and Definitions
To assist medical device manufacturers and other parties involved with the correct interpretation of the applicable regulations, the present guidance provides definitions of the most important terms and concepts used in the context of the Essential Principles of Safety and Performance. Some of the terms are also defined in the respective legislation, including the Health Products Act and Health Products (Medical Devices) Regulations 2010. The guidance explains the most important terms in a way that will be understandable for persons without the respective background in healthcare. The definitions provided in the guidance include, inter alia, the following ones:
- Analytical performance (of an in vitro diagnostic medical device) – the ability of an IVD medical device to detect or measure a particular analyte;
- Clinical evaluation – the assessment and analysis of clinical data about a medical device to verify the clinical safety and performance of the device when used as intended by the product owner;
- Clinical evidence – all the information that supports the scientific validity and performance for its use as intended by the product owner;
- Clinical investigation – any designed and planned systematic study undertaken on human subjects to verify the safety or performance of a specific medical device;
- Label – 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.
For some of the terms, the document provides in-depth descriptions and additional clarifications. For instance, it is explained that the term “stability” refers to the ability of the product to maintain its performance characteristics throughout the whole period of shelf life and intended use. This means that the characteristics of the device should not be adversely impacted by storage, transportation, or use provided that the appropriate instructions communicated by the manufacturer are strictly followed. At the same time, a bit specific meaning of “stability” should be considered in the case of IVD reagents or measuring systems – it will refer to the ability of the product to react properly and within the appropriate period.
The authority also mentions that the concept of “labeling” covers all the materials supplied with a medical device placed on the market and used by the manufacturer to communicate the important information related to the way the device should be stored, transported, and used to ensure the safety and effectiveness.
In summary, the present HSA guidance provides an overview of the regulatory framework associated with the Essential Principles of Safety and Performance and highlights the key points to be considered in this respect. The document also provides the definitions of the most important terms and concepts.
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