Dental device tools including dentures

Dental Laboratory Regulatory Requirements In Singapore

A confidence-based, risk-calibrated approach to regulatory controls of Local Standalone Dental Laboratories will be taken by Health Sciences Authority (HSA) Singapore, as announced via an online webinar held on 10th May 2022. This effects:

  • Manufacturing only Class A and/or Class B custom-made dental devices
  • Not licensed by Ministry of Health (MOH) under the Private Hospitals and Medical Clinics Act (PHMCA)

Key requirements of Local Dental Laboratories:

  • QMS – perform only one-time notification on local manufacturing site location and scope of activities, no fees applicable
  • Product control – perform notification of type of dental medical device prior to supply, no registration fees applicable
  • Post-market control – all post-market obligations such as AEs, FSCAs, distribution records and complaints shall remain applicable

Full implementation is expected in Quarter 3, 2023. 

You can view the slides from the online webinar here.

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