sec-1

1. Introduction

1.1 Objective The Health Sciences Authority (HSA) is issuing these guidelines to provide clarity on the types of Telehealthproducts that are regulated as medical devices, as well as its current regulatory approach and requirements for such products regulated by HSA. The guidelines reflect HSA’s current policy stance and practice, and should not be misconstrued as a new regulatory control on Telehealthproducts. 1.2 Background Telehealthproducts are instruments, apparatus, machines or software (including mobile applications) that are involved in the provision of healthcare services over physically separate environments via infocommtechnologies (including mobile technology),categorisedinto four broad domains: •Tele-collaboration; •Tele-treatment; •Tele-monitoring; •Tele-support. As not all Telehealthproducts in the market are medical devices, this document serves to provide clear guidelines on identifying a Telehealthmedical device. As a general rule, a Telehealthproduct intended for medical purposessuch as investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process; will be classified as a medical device subject to regulatory controls by HSA. In recent years, Telehealthtechnology has advanced at a rapid pace of innovation and introduced a myriad of benefits, along with some potential risks to public health. As part of Singapore’s Smart Nation initiatives, HSA aims to refine and streamline its regulatory framework for Telehealthmedical devices, so as to promote better innovation and efficiency in our healthcare sector. The regulatory approach adopted will be largely similar to the regulatory principles applied in the regulation of the other medical devices –they are: •Risk-based regulation –HSA employs a rule-based approach (GN-13: Guidance on Risk Classification of General Medical Devices) to classify medical devices into four risk classes (A, B, C & D), according to the nature of the device and its intended functions. The level of scrutiny and regulatory requirements on a medical device will in turn commensurate with its risk class. •Confidence-based regulation –The evaluation routes (e.g. Immediate Class B/C Registration route, Expedited Class C/D Registration routes and etc.) for medical devices are set out according to a confidence based approach by leveraging on the approvals of HSA’s reference regulatory agencies and/or prior safe marketing history of the medical devices. The submission requirements (GN-15: Guidance on Medical Device Product Registration) are titrated according to the evaluation routes that the device qualifies. This will allow faster access to new and innovative Telehealthmedical devices to provide high quality Telehealthservices to healthcare professionals, patients and consumers, whilst safeguarding public health. 1.3 Scope This document applies to all Telehealthproducts which include hardware devices, software and mobile applications, specifically on the classification and regulation of such products. It does not cover the practice of Telehealthservices as this falls out of HSA’s purview. 1.4 Definitions PRODUCT OWNER (as stated in the Medical Device Regulations): in relation to a health product, is defined as a person who — suppliesthe health product under his own name, or under any trade mark, design, trade name or other name or mark owned or controlled by him; and is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the health product, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf. TELEHEALTH: The provision of healthcare services over physically separate environments via infocomm technologies,categorisedinto four broad domains: •Tele-collaboration; •Tele-treatment; •Tele-monitoring; •Tele-support. TELE-COLLABORATION:It refers to 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: It refers to the provision of direct clinical care e.g. triage, history, examination, diagnosis and treatment including robotic surgery from a remote location via infocommtechnologies (including mobile technology). TELE-MONITORING: It refers to biomedical and other forms of data collection 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-monitoring is used in remote chronic disease management e.g. management of hypertension (blood pressure), diabetes (blood glucose) and coronary heart disease (weight, ECG). TELE-SUPPORT:It refers to the use of online services for non-clinical (i.e. educational and administrative) purposes to support the patient, caregiver or user. TELEHEALTH PRODUCTS: All forms of devices, including hardware devices, software and mobile applications, used in the delivery of Telehealthservices.WELLNESS DEVICE: A device or software which is intended by its Product Owner to be used only to enable or encourage the user of the device or software to adopt or maintain a healthy lifestyle, or for the user’s general wellbeing, but not to be used for any specific medical purposes.

sec-2

2. Categorisation of Telehealth Products as Medical Devices

PRODUCTS AS MEDICAL DEVICES The intended useof the Telehealthproducts will determine whether it will be regulated as a medical device. The intended use is reflected on the specifications, instructions and information provided by the Product Owner of the device. If the Telehealthproduct is intended by the Product owner to be used for investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process, it is a Telehealthmedical device and is subject to HSA’s regulatory control. On the other hand, if the Telehealthproduct is intended by the Product Owner to be usedas a wellness device(e.g. intended for fitness tracking), but is able to perform such medical function/ purpose (e.g. monitoring heart rate), Product Owners are required to include the following “clarification statement” (or equivalent) on their labels to clearly inform the users of the product’s appropriate use:“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.” PRODUCTS AS MEDICAL DEVICES This information should be presented clearly to the users, where practicable (e.g. Packaging, Instructions for use (IFU) or splash screen/loading screen in a mobile application). This is necessary to ensure that users do not misconstrue any health-related information accessed through these devices as medical advice. Users should still seek proper medical advice from a physician regarding any health-related issues. For a step by step decision tree to determine whether a Telehealthproduct is a Telehealth medical device, please refer to Flowchart 1 for more details.

flowchart-1

Flowchart 1: Is a Telehealth Product a Medical Device?

Device? TelehealthProducts Notmedicaldevice. Examples: 1.Commercialoff-the-shelfmobile platforms(e.g.genericsmartphones andtablets)thatarenotintendedtobe usedformedicalpurposebythe ProductOwner. 2.Onlineeducationalmedicalinformation (Tele-support). 3.Webcamtomonitorthemovementsof elderlypeopleathomeremotely(Tele- monitoring). 4.AppsthatcancalculateBMIortotal watercontentbasedonspecificinput parametersbutdonotperformany diagnosisortherapeuticfunctions. 5.Telehealthproductsthatareintended solelyforcommunicationpurposes suchasvideoconferencesystemsthat areintendedsolelytoperformremote consultationsbetweenclinicsand patients. 6.Softwareisintendedsolelyforstoring, retrievingofmedicaldataanddoesnot processtheinformationforpatient management/monitoringordiagnosis ofmedicalcondition. Can the device and/or mobile applications be used for purpose of investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process? No Yes Device? No Yes Is the device labelled with a statement from Product Owner that: 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 or contraception). 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. Not medical device. Examples: 1.Heart-ratemonitorsinsmart phonesorwatchesforlifestyle purposesandnotformedical diagnosis. 2.SpO2metersforuseby athletesandnotintendedfor medicaldiagnosisor monitoringpurpose. The device is a Medical Device. Examples: 1.RemoteSurgicalSystemsthatallowdoctorstoperformsurgeryonapatienteventhoughtheyarenotphysicallyinthesamelocation. 2.Remotepatientmonitoringdevice: •Softwareorapplicationthatmonitorsandtransferspatient’sdatatoacentralviewingstationfordisplayandpatientmonitoring. •SoftwareorapplicationthatdisplaysECGorothervitalsignsinremotelocationastransmittedfrompatientsideformonitoringpurpose. 3.Mobilemedicalappsthattransformamobileplatformintoaregulatedmedicaldevice. •Mobileappsthatuseasensororleadthatisconnectedtoamobileplatformtomeasureanddisplaytheelectricalsignalproducedbytheheart(electrocardiographor ECG). •Mobileappsthatuseanattachmenttothemobileplatformtomeasurebloodoxygensaturationfordiagnosisandmonitoringofspecificdiseaseorcondition.

sec-3

3. Risk Classification of Telehealth Medical Devices

TELEHEALTH MEDICAL DEVICES As with all other medical devices, the Telehealthmedical devices are classified into different risk classification (as shown in Table 1), depending on the nature of the device and its intended functions. Increasing risk High Risk Low Risk App used for measurementof heart rate and ECG –single measurements Software for prediction of low blood glucose level episodes in patients based on past glucose measurements & diet App used for continuous / live measurement and monitoring of ECG and irregular heart rate management in cardiac patients Apps for measurement of blood glucose in whole blood and recommendation of medication dosage Software or app that does not measure, analyze or monitor patient parameters and solely displaysreal time patient physiological parameters derived from another device (e.g. patient monitor) N.A. Table 1: Examples of TelehealthMedical Devices of various risk classes. TELEHEALTH MEDICAL DEVICES If the device is intended to monitor or predict any disease or medical conditions or to measure, analyze or monitor physiological parameters (e.g. SpO2, ECG measurement) it will be in a higher risk category as compared to a device that solely displaysreal time patient physiological parameters This is because of the greater impact on patient health and safety when the higher risk device fails. Hence, the level of scrutiny and regulatory requirements on a medical device will commensurate with its risk class. To determine the risk classification of Telehealthmedical devices, please refer to Flowchart 2 (Risk Classification of TelehealthMedical Devices) for more details. The flowchart is based on the current risk classification rules as per GN-13 and is meant to provide guidance in layman terms. The following sections are applicable to industry members that are dealing with Telehealth medical devices and standalone mobile applications that are medical devices.

flowchart-2

Flowchart 2: Risk Classification of Telehealth Medical Devices

Medical Devices Class C Medical Device Examples: 1.Devicesusedforcontinuous/real-time measurementandmonitoringofECGand heartrateforarrhythmiamanagementin cardiacpatients. 2.Deviceswhichcancontroland/ormonitor pacemaker. 3.Radiotherapyplanningsoftwareusedto controlandinfluencetheemissionof ionisingradiationtobeadministeredto patient. Class B Medical Device Examples: 1.Standalonemobileappforpredictionof hypoglycemiaepisodesinpatientsbasedon pastglucosemeasurements. 2.Therapeutichandheldultrasoundprobefor usewithmobiledevices. 3.Standalonemobileappthatanalysesan imageofaskinlesionusingmathematical algorithms,suchasfractalanalysis,and provideautomatedskindiseasediagnosis. No Yes Yes Isthedevicedesigned/intended: •Forcontinuousmonitoringofphysiological parameters; OR •Toprovidetherapyrecommendationsor modifyon-goingtherapies; OR •Fordiagnosis,monitoring,managementor treatmentofcriticallyillpatients. Is the device designed/ intended: •Formeasuringphysiologicalparametersor aidindiagnosis; OR •Toadministerorexchangeenergyinanon- hazardousway(e.g.electricalstimulation, ultrasoundetc.) Medical Devices Class A Medical Device Examples: 1.Softwareorappthatdoesnotmeasure,analyseormonitorpatientparametersand solelydisplaysreal-timepatientphysiologicalparameters(e.g.heart-rate,ECGandetc.). 2.Mobileappthatisintendedtocollectandmeasurethedegreeoftremorin patientswithParkinson’sdiseaseviathesmartphoneinbuiltaccelerometer.The informationislatersenttothephysicianforreviewwheretheappitselfdoesnotcarry outanyanalysisofthepatientcondition. No

sec-4

4. Regulatory Controls for Telehealth Medical Devices

TELEHEALTH MEDICAL DEVICES Telehealthproducts that are “medical devices” (Telehealthmedical devices) are subject to the following medical device regulatory controls: a)Product Registration; (where applicable) b)Dealer’s licence requirements; c)Post-market obligations. (a) Product Registration: In order to supply a Telehealthmedical device in Singapore, the company is required to obtain marketing clearance for the device from HSA via Product Registration before supply of the devices in Singapore unless the device is a Class A device. The submission requirements and process, depending on the risk class of the Telehealthmedical device, will follow as per GN-15: Guidance on Medical Device Product Registration. Please note that Class A Telehealthmedical devices will have exemption from Product Registration with HSA. Therefore, such devices are able to be supplied immediately. TELEHEALTH MEDICAL DEVICES Table2:Theeligibilitycriteriaforevaluationroutes. TELEHEALTH MEDICAL DEVICES Local manufacturers and importers that are dealing with such Class A Telehealthmedical devices only will be required to declare these devices in the Class A exemption list found under the importer’s and manufacturer’s licences and update the list prior to import. Like all other medical devices, Telehealth medical devices undergo changes as part of their product life cycle. Please refer to GN-21: Guidance on Change Notification for Registered Medical Devices to determine whether a Change Notification submission to HSA is required for specific proposed changes to a medical device that is registered on the Singapore Medical Device Register (SMDR). (b) Dealers’ Licence requirements: If you want to engage in the manufacture, import and/or wholesale of Telehealthmedical devices in Singapore, you will need to obtain the appropriate dealer licences from HSA. The submission requirements and process will follow as per GN-02: Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices. This licensing requirement is to ensure proper traceability and post-market monitoring of Telehealthmedical devices marketed in Singapore.For companies dealing with only Class A medical devices (sterile or non-sterile), they may submit a declaration of conformity (DoC) to a Quality Management System, in lieu of the ISO 13485 or GDPMDS certification, for the application of manufacturer, importer or wholesaler licence. For more information, please refer to GN-02Guidance. TELEHEALTH MEDICAL DEVICES (c) Post-market obligations: Dealers of Telehealthmedical devices are obliged to perform post-market duties, including but not limited to reporting of adverse events, defects and recall to HSA and ensuring appropriate investigation, so as to assure the continued safe use of the devices. Healthcare professionals and users of Telehealthmedical devices may also report any adverse events related to the use of a medical device or device failure related issues to HSA on a voluntary basis.

sec-5

5. Regulatory Controls for Standalone Mobile Applications that are Medical Devices

MOBILE APPLICATIONS THAT ARE MEDICAL DEVICES Standalone Mobile Applications refers toa software and/or mobile application that is intended to function by itself and are not intended for use to control or affect the operation of other hardware medical devices. Typically such “standalone” mobile applications include algorithm based calculators of specific parameters for use in clinical practice or for use in diagnosis or managing a disease or condition. Such applications are required to be designed based on formulas with established scientific evidence and clinical utility. Where such Class B or Class C Standalone Medical Mobile application has been registered by one of HSA’s reference agencies and its clinical utility has been reviewed by the agency, they may qualify for Immediate Registration Route. MOBILE APPLICATIONS THAT ARE MEDICAL DEVICES The eligibility criteria for the Immediate Registration Route at the point of submission are: •Approval by at least one of HSA’s independent reference agencies for intended use identical to that submitting for registration in Singapore [HSA’s independent reference regulatory agencies are i) Health Canada, ii) Japan’s Ministry of Health, Labour and Welfare, iii) United States Food and Drug Administration, iv) Australian Therapeutic Goods Administration v) European Union Notified Bodies and the corresponding approvals indicated in GN-15.] •No safety issues globally associated with the use of the medical device(s) when used as intended by the Product Owner, in the last three years or since the launch of the medical device(s) globally, defined as a.No reported deaths; b.No reported serious deterioration in the state of health of any person; and c.No open field safety corrective actions (including recalls) at the point of submission. •No prior rejection/withdrawal of the medical device by/from any reference regulatory agency/that foreign jurisdiction(s) or HSA/Singapore due to quality, performance/efficacy or safety issues. MOBILE APPLICATIONS THAT ARE MEDICAL DEVICESPlease refer to GN-15: Guidance on Medical Device Product Registration for further details on product registration, including submission requirements, process, turn-around-time and fees. Please note that other standard regulatory controls (i.e. Dealers’ Licence and Post-Market obligations) are still applicable to standalone mobile applications that are medical devices. With the widespread and rampant adoption and use of mobile applications and virtual distribution of these applications and devices globally, it is important to note that only local online platforms are within the local regulatory purview.