Proposed Regulatory Guidelines for Telehealth Devices

Health Sciences Authority (Health Products Regulation Group)

Consultation Period: 17 Oct 2016 - 30 Nov 2016

Status: Closed - Summary of Responses

Consultation Outcome

Conclusion to the Consultation on the Regulatory Guidelines for Telehealth Products

1. The Health Sciences Authority (HSA) would like to thank our stakeholders for your feedback on the proposed regulatory guidelines for Telehealth products that were posted for consultation from 17 October 2016 to 30 November 2016.

2. These guidelines are meant to provide clarity on the types of Telehealth products that are regulated as medical devices. The guidelines also present an overview of the proposed regulatory approach for such Telehealth products which is largely similar to the regulatory principles for all medical devices.

3. As part of this consultation on the proposed guidelines, HSA received a total of 155 responses from 61 respondents over the consultation period. Majority of the feedback received came from the industry sector (52%), followed by healthcare professionals and healthcare institutions (39%). The rest came from government agencies and the general public. 

4. In summary, the feedback received were in support of the proposed guidelines. Majority of the feedback consisted of editorial and technical clarifications on the guidelines. Technical clarifications include how HSA classifies and regulates Telehealth products as medical devices and labelling requirements of Telehealth products. There were also questions on how standalone mobile medical devices are regulated. 

5. HSA has identified common themes based on the feedback raised by the various stakeholders and incorporated them into the Telehealth guidelines to improve clarity. HSA has also compiled a list of FAQs based on the feedback to enable better understanding on the Telehealth guidelines. There is no change on the policy position and regulatory control made to these guidelines. You may access both the finalised Telehealth guidelines and FAQ document here. 

6. Do note that the new Immediate Registration Route for Standalone Mobile Applications will be available at a later date when the legislation for medical devices - Health Products (Medical Devices) Regulations are updated. 

7. If you are developing a Telehealth product with novel technology or intended purpose, we encourage you to contact the Medical Devices Branch (email: HSA_MD_Info@hsa.gov.sg) to discuss the regulatory requirements that may apply.

HEALTH PRODUCTS REGULATION GROUP

HEALTH SCIENCES AUTHORITY

SEPTEMBER 2017

Detailed Description

Background 

1. Telehealth devices are instruments, apparatus, machines or software (including mobile applications) that are involved in the provision of healthcare services over distance via infocomm technologies, categorised into three broad service areas:

   1. Clinical services e.g. Tele-radiology, Tele-consultation

   2. Education e.g. Educational web portals

   3. Administration e.g. Care management systems

2. A Telehealth device may or may not be classified as a medical device (MD), depending on the intended purpose. This consultation is to provide clarity on the types of Telehealth devices that are MDs. The consultation will also look into the proposed regulatory approach which is largely similar to the regulatory principles for other MDs.

Key guidelines under review

3. A Telehealth device is classified as an MD if it has a medical intended use. Please refer to the consult document below for more information.  

4. A Telehealth device intended for a person’s general well-being will not be regulated as an MD, but will be subjected to certain labelling requirements. Please refer to the consult document below for more information.

5. Risk classification of Telehealth devices that are MDs will be classified into one of the four risk classes (risk class A to D). 

6. Telehealth devices that are MDs will be subjected to the following MD regulatory controls: Product Registration, Dealer’s Licensing, and Post-market obligations.

7. Regulatory controls for standalone mobile applications that are MDs will be subjected to the same regulatory controls as other MDs. Only standalone mobile applications that are distributed on local online platforms will be regulated.

Your Feedback is Important

8. HSA welcomes your comments and feedback on the proposed regulatory guidelines on Telehealth devices provided in the consult document below. The consultation window will be from 17 October 2016 to 30 November 2016.

9. Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.

10. Please provide your feedback using the prescribed excel template below and send it to HPRG_feedback@hsa.gov.sg by 30 November 2016. 

Proposed regulatory guidelines for Telehealth devices [PDF, 218 KB]

HSA Telehealth Consultation Prescribed excel template [XLXS, 12 KB]