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