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KD&A - Regulatory Consultants for Medical and IVD devices

kdent@kdas.com.au
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logo main
  • About Us
    • What our Clients Say
    • Frequently Asked Questions
    • Useful Links
  • Our Services
    • Medical Device Regulatory Strategy
    • ISO 13485 & MDSAP QMS Creation and Maintenance | KD&A Expert Regulatory Support
    • Internal Auditing & Audit Support (ISO 13485) | KD&A Expert Regulatory Support
    • Technical File Documentation | KD&A Expert Regulatory Support
    • Global Medical Device Registrations & ARTG Inclusions | KD&A Expert Regulatory Support
    • Post Market Surveillance (PMS) | KD&A Expert Regulatory Support
    • TGA Conformity Assessment and CE Marking | KD&A Expert Regulatory Support
    • Promotional Materials Review | KD&A Expert Regulatory Support
    • Australian TGA Sponsor Services | KD&A Expert Regulatory Support
    • Medical Device & IVD Classification Assessment | KD&A Expert Regulatory Support
    • Software as a Medical Device | KD&A Expert Regulatory Support
    • Retainer Services | KD&A Expert Regulatory Support
  • Our Clients
    • Australian Sponsors & Distributors | KD&A Expert Regulatory Support
    • Medical Device Manufacturers | KD&A Expert Regulatory Support
    • International Medical Device Manufacturers | KD&A Expert Regulatory Solutions
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May 2025

22
May
Regulatory ChangesTGA

What You Need to Know About Australia’s Unique Device Identification (UDI) System in 2025

Australia’s medical device regulatory landscape continues to evolve, and 2025 has brought significant updates to the Unique Device Identification (UDI) system that manufactur

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Latest Articles
July 21, 2026
ISO 20417:2026 Has Been Published: What Medical Manufacturers Need to Know
June 25, 2026
Understanding Australia’s Consent to Supply Mechanism for Medical Devices
May 19, 2026
TGA Now Accepting UK Conformity Assessed (UKCA) Certification as Comparable Overseas Evidence: What This Means for Medical Device Sponsors
April 23, 2026
From Voluntary to Mandatory: The Evolution of Post-Market Surveillance in Australia
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Australia Australian Medical Device Regulatory Framework European Union Manufacturer's Evidence Medical Device Medical Device Regulations Medicinal Substances Regulatory Changes Regulatory Compliance Regulatory Requirements Regulatory Strategy TGA

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+ 61 411 101 392
kdent@kdas.com.au

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KD&A provides expert regulatory consulting service to medical device and IVD companies selling on Australian and International markets.

    Contact us:
    kdent@kdas.com.au
    +61 411 101 392
    Our address:
    Suite 13,
    67 Wanganella Street,
    Balgowlah NSW 2093, Australia
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