TGA Compliance

Meeting the highest standards in regulatory compliance.

Regulatory Excellence

Shiny Dental Lab operates in full compliance with the Therapeutic Goods Administration (TGA) requirements for custom-made medical devices.

All our dental prosthetics are manufactured in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002 and meet the Essential Principles for safety and performance.

Our TGA registration details will be displayed here once available.

TGA Compliant

Australian Made

ISO Standards

Quality Assured

Our Compliance Framework

Quality Management

Quality management system aligned with ISO 13485
Documented procedures for all manufacturing processes
Regular internal audits and quality reviews
Continuous improvement processes

Material Traceability

Full batch traceability for all materials
Certificates of conformity maintained
Only TGA-listed materials used
Supplier qualification process

Record Keeping

Complete case documentation retained
Digital records stored securely
Records maintained as per TGA requirements
Easy retrieval for audit purposes

Staff Training

Qualified dental technicians
Regular compliance training
Manufacturer certification on equipment
Ongoing professional development

100% Australian Made

Every restoration that leaves our laboratory is manufactured right here in Sydney. We're proud to support Australian jobs and maintain the highest quality standards by keeping our entire production process local.

Questions About Compliance?

If you have questions about our regulatory compliance or require documentation, please contact us.