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Health Sciences Authority
Regulatory Updates

Regulatory Guidelines for Telehealth Products and Devices for Modification of Appearance or Anatomy

Audiences

Healthcare professional

Industry member

Product type

Medical devices

1 June 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

REGULATORY GUIDELINES FOR TELEHEALTH PRODUCTS Rev 2.0 [pdf]

FAQ-REGULATORY GUIDELINES FOR TELEHEALTH PRODUCTS Rev 2. [PDF, 402 KB]

Aesthetic-Related Guidelines_ [PDF, 462 KB]

Implementation of the Amendments to the Medical Device (MD) Regulations (1 June 2018)

HSA has amended the Health Products (Medical Devices) Regulations and will be implementing these amendments with effect from 1 June 2018. The key amendments being implemented are in line with what we have shared during our briefing session to stakeholders in February 2018.

With this amendments, we have also updated our guidance documents and guidelines. Please visit our website for the updated documents.

We wish to take this opportunity to thank all stakeholders who have participated in our various focus group and engagment sessions in the course of the last 2 years on the various regulatory policies leading to these amendments and also to those who have provided your comments and feedback during the consultation on our guidance documents.

We look forward to your continued support and engagement.

Medical Devices Branch

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