The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices, has published a guidance document dedicated to the regulatory requirements for telehealth products. The document provides an overview of the applicable legislation, as well as additional recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with the requirements these products are subject to. At the same time, the authority explicitly states that the document is not intended to introduce new rules or obligations the parties involved should follow.
First of all, the document defines telehealth products – according to the guidance they are instruments, apparatus, machines, or software (including mobile applications) that are involved in the provision of healthcare services over physically separate environments via Infocomm technologies (including mobile technology), categorized into four broad domains:
The authority further mentions that not all Telehealth products meet the definition of a medical device. Thus, to assist medical device manufacturers (software developers) in determining the regulatory status of their products and the framework to be applied, the authority has issued the present guidance.
As it is further explained by the HSA, such a determination should be based on the intended purpose of the product in question: should it be intended for medical purposes (e.g., investigation, detection, diagnosis, monitoring, treatment, or management of any medical condition, disease, anatomy or physiological process), it should be treated as a medical device, and all the respective regulatory requirements should be applied.
The authority acknowledges the accelerated development of innovative technologies, including the ones used in Telehealth products. Such a development creates not only new clinical benefits for the patients but also additional risks associated with the use of such products for their intended purposes. Hence, it is vitally important to ensure the benefit-risk balance is duly evaluated. In this respect, the authority intends to take all the steps necessary to improve the existing regulatory framework to ensure the timely availability of novel Telehealth products on the market provided they do not expose customers to extensive risks.
According to the guidance, the approach to be applied to Telehealth products is quite similar to the one applied for medical devices. In particular, it is based on the following key principles:
- Risk-based regulation. Any medical devices allowed to be marketed and used in Singapore are divided into four classes from A to D based on the risks associated thereto, while the requirements these devices are subject to actually correspond to their class under the aforementioned risk-based classification.
- Confidence-based regulation. Existing legislation also provides special accelerated pathways for certain medical devices. The authority decides on the scope of applicability of these pathways based on the assessment carried out by other regulating authorities, as well as the prior marketing history of the product in question. In this regard, the authority refers to the general Guidance on Medical Device Product Registration.
As it was mentioned before, the authority intends to ensure the application framework does not impose an unneeded regulatory burden while ensuring the safety and effectiveness of the products allowed for marketing and used in the country.
According to the guidance, its scope covers all Telehealth products including both hardware and software products. At the same time, the document does not address the matters related to Telehealth services.
Apart from the general definition of a Telehealth product, the document provides other definitions of the most important terms and concepts including, inter alia, the following ones:
- Tele-collaboration – interactions between (facility-based or mobile) onsite and remote healthcare professionals for clinical purposes e.g. referral, co-diagnosis, supervision, or case review.
- Tele-treatment – the provisions of direct clinical care e.g. triage, history, examination, diagnosis, and treatment including robotic surgery from a remote location via Infocomm technologies (including mobile technology).
- Tele-monitoring – biomedical and other forms of data collected directly from patients (or through caregivers) by remote systems, which are used by healthcare professionals for clinical purposes such as vital signs monitoring and home nursing.
- Tele-support – the use of online services for non-clinical (i.e. educational and administrative) purposes to support the patient, caregiver, or user.
In addition to the ones listed hereinabove, the guidance also provides definitions of such terms as “product owner”, “telehealth products”, “wellness device”.
The guidance also describes the categorization of Telehealth products as medical devices. As it was mentioned before, the regulatory status of Telehealth products should be determined based on their intended use, which is indicated in the respective specifications, instructions for use, and other documents supplied by a party responsible for the product. Should the product subject to review be intended for medical purposes, such a product should be considered a medical device. At the same time, should the product be intended for general wellness purposes, but also include some of the functions covered by the definition of a medical device, the responsible party should provide the appropriate “clarification statement” to communicate all important information to the users. Such a statement should be included in the labeling of the product. The guidance also provides an example of such a statement: “This device or software is intended for use only for general wellbeing purposes or to encourage or maintain a healthy lifestyle, and is not intended to be used for any medical purpose (such as the detection, diagnosis, monitoring, management or treatment of any medical condition or disease). Any health-related information provided by this device or software should not be treated as medical advice. Please consult a physician for any medical advice required”. The authority explicitly states that this information should be visible to the customers. According to the guidance, it is vitally important to ensure the information provided by such a product would not be construed as medical advice of any kind.
To assist medical device manufacturers (software developers) in determining the regulatory status of their products, the guidance also provides a flowchart describing the way the product should be assessed. According to the flowchart, the questions to be assessed include the following ones:
- Whether the device in question is intended to be used for any of medical purposes; and
- Whether the device contains a statement indicating the nature of the product and information it provides as described hereinabove.
In summary, the present HSA guidance describes in detail the regulatory approach to be applied to Telehealth products. The document highlights the most important aspects to be considered when determining the regulatory status of such products and the particular framework to be applied.
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