Singapore: New Dental laboratory requirements in Singapore (No QMS certification required for Class

• Local dental laboratories have experience with manufacturing custom-made dental MDs

• Locally manufactured custom-made dental MDs

- have had no serious safety incidents reported so far

- are typical of lower risk class (risk class A and B)

- are manufactured based on a prescription and fitted by registered dentists

1. Dealers Control (Manufacturing Activity)

• Standalone dental laboratories manufacturing higher-risk MDs (Class C and /or Class D) will be subject to standard regulatory requirements.

2. Product Control

3. Post-market Control

• All post-market obligations will apply,e.g.

–Mandatory reporting of field safety corrective actions and adverse events

–Maintenance of distribution records and complaints

Source:

Dental Laboratory Requirements

Contact us at info@arqon.com for more information.