Webinar on Dental Laboratory Regulatory Requirements in Singapore

The Health Sciences Authority, Singapore organised a Zoom webinar on 10th May 2022 covering the upcoming risk-calibrated requirements for local standalone dental laboratories.

Local standalone dental laboratories that manufacture only custom-made Class A and/or Class B dental devices will no longer require a Manufacturer's Licence. They will only be required to:

• Have a Quality Management System in place for their manufacturing site (no certification required),

and

• Submit a notification to HSA

Please find more information in the presentation slides attached below:

Dental Laboratory Requirements Singapore May 2022_v3410 KB

The dental laboratory notification form is now available online at https://go.gov.sg/dentallab-notification. Please refer to the attached document for a step-by-step guide through the notification process.

Dental Lab Notification Process Step Guide515 KB

The legislative updates for these requirements and mandatory notification to HSA will take effect from 9 January 2023. Dental laboratories that fall within the above category should submit the notification form by 9 January 2023. Subsequently, the notification form should be submitted prior to manufacture of any new type of custom-made Class A and/or Class B dental devices.

For clarifications regarding dental laboratory requirements or the notification form, please email HSA_MD_Info@hsa.gov.sg with the email subject "Dental Laboratory".

Published: 1 Apr 2022

Regulatory Updates