The second article in our series covering HSA Guidance in Telehealth Products focuses the applicable classification rules for Telehealth products, and also specific regulatory controls these products are subject to.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices, has published a guidance document dedicated to Telehealth products. The document provides an overview of the applicable regulatory requirements and also highlights the key points to be considered by medical device manufacturers (software developers) to ensure compliance thereto. At the same time, anything provided in the document should not be construed as legal advice of any kind due to the non-binding legal nature of its provisions, while the recommendations provided could be subject to changes reasonably necessary to reflect the respective changes in the applicable legislation.
Classification: General Rules
First of all, the authority mentions that Telehealth products are subject to risk-based classification the same way as it applies to other medical devices. Hence, the aspects to be considered when determining the applicable class include, inter alia, the intended purpose of a medical device in question, as well as its functionality. The document further provides several examples demonstrating the way the classification rules should be applied, namely:
- Class A, which is associated with the lowest risk to public health, could be applied to software or app that does not measure, analyze or monitor patient parameters and solely displays real-time patient physiological parameters derived from another device (e.g., a patient monitor);
- Class B applies to an app used for measurement of heart rate and ECG – single measurements;
- Class C will cover an app used for continuous/live measurement and monitoring of ECG and irregular heart rate management in cardiac patients; as well as apps for measurement of blood glucose in whole blood and recommendation of medication dosage.
It is also important to mention that according to the chart provided in the guidance, Class D, which refers to the highest class under existing risk-based classification, should not be applied to Telehealth products.
Under the general rule, should the device in question be intended to monitor or predict any disease, the applicable classification will be higher when compared to a product intended merely to display parameters due to a more significant impact the product will have on the health of a patient. The same approach applies in the case of medical devices intended to analyze or monitor physiological parameters. Consequently, the level of scrutiny and regulatory requirements on a medical device will be commensurate with its risk class.
To assist medical device manufacturers (software developers) in determining the class of their product under the applicable risk-based classification, the authority provides a flowchart that describes the procedure to be followed in detail. The authority mentions that the procedure described therein is based on the recent guidance on medical device classification and is intended to illustrate the main points to be considered. In particular, the flowchart provides the following criteria to be applied:
- Class C applies to medical devices intended:
- For continuous monitoring of physiological parameters; or
- To provide therapy recommendations or modify ongoing therapies; or
- For diagnosis, monitoring, management, or treatment of critically ill patients.
- Class B applies to medical devices intended:
- For measuring physiological parameters or aid in diagnosis; or
- To administer or exchange energy in a non-hazardous way (e.g., electrical stimulation, ultrasound, etc).
- Class A applies to medical devices intended to merely display real-time patient physiological parameters.
Apart from the classification rules and the way they should be applied, the guidance also describes the applicable regulatory control Telehealth products are subject to. According to the guidance, these controls include:
- Product Registration;
- Dealer’s license requirements;
- Post-market obligations.
The guidance further describes each of them in detail.
Under the general rule, any telehealth medical devices intended to be marketed in Singapore should be allowed for marketing and used by the virtue of a respective clearance to be granted by the authority under the Product Registration framework, except Class A medical devices with the lowest risk for public health associated thereto. The particular procedure to be followed is described in the respective HSA guidance on medical device product registration, while Class A medical devices could be placed on the market immediately – it would be sufficient for an entity responsible for such a device to declare the products in question in the Class A exemption list before placing them on the market. The authority also mentions that Telehealth products are also subject to change notification requirements for medical devices. To assist medical device manufacturers (software developers) in ensuring compliance with these requirements, the authority has already published a detailed guidance document describing the approach to be applied to determine the regulatory status of changes and the way a respective notification should be provided to the authority. In particular, additional information on changes to medical devices already registered in the Singapore Medical Device Register (SMDR) should be submitted to the authority.
Any party interested in undertaking the activity in the sphere of Telehealth products in the country should apply for and obtain the appropriate license from the regulating authority. The particular requirements, as well as the procedure to be followed, are described in the respective Guidance on Licensing for Manufacturers, Importers, and Wholesalers of Medical Devices published earlier by the HSA. At the same time, in case the product to be manufactured, supplied, or distributed is a Class A medical device, a simplified approach could be applied as well – in particular, it will be sufficient to submit a declaration of conformity (DoC) to a Quality Management System. As it is stated by the HSA, the licensing regime for establishments involved in operations with medical devices is intended to ensure proper traceability and post-marketing monitoring of Telehealth medical devices marketed in Singapore.
Under existing regulatory requirements, the parties involved in the distribution of Telehealth products should follow the requirements on post-market surveillance, e.g., reporting adverse events, defects, and recall to HSA and ensuring appropriate investigation, to assure the continued safe use of the devices. At the same time, end-users of Telehealth products are also entitled to report adverse events they are aware of directly to the regulating authority.
In summary, the present HSA guidance provides an overview of the applicable risk-based classification for medical devices and describes the particular way it should be applied in the case of Telehealth products. The document also highlights the most important aspects associated with the regulatory controls Telehealth products are subject to.
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