Skip to the content

KD&A - Regulatory Consultants for Medical and IVD devices

kdent@kdas.com.au
logo mainlogo darklogo light
  • About Us
    • About Us
    • What our Clients Say
    • Frequently Asked Questions
  • 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
    • Our Clients
  • News
  • Useful Links
Get In Touch
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
  • Latest News
  • Contact Us

NZ Tag

27
Nov
TechnologyTGA

Red light on ANZTPA

The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue.

Read More
Share
24
Jul
Regulatory Changes

Revised Medical Device Definitions Implemented in New Zealand – Effective 1 July 2014

In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for definin

Read More
Share
27
Jun
TGA

Advertising – What’s Required? All the Info You’ll Need for Australia and New Zealand

In the world of marketing, it is very easy to forget that there are legal requirements associated with the advertising of therapeutic goods. Medical device suppliers and manufactur

Read More
Share
06
Dec
Regulatory ChangesTGA

Early Warning Mechanisms for Australia and New Zealand

The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing a

Read More
Share
18
Jul
Regulatory ChangesTGA

Harmonisation for Australia and NZ on the Horizon

Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The jo

Read More
Share
News Categories
  • EU
  • FDA
  • International Standards
  • KD&A
  • Medical Device Classification
  • Regulatory Changes
  • Research
  • Software
  • Technology
  • TGA
  • UK
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
Tags

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

  • What We Do
  • Who We Help
  • What our Clients Say
+ 61 411 101 392
kdent@kdas.com.au

Get our latest expert updates to your inbox

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
    Our social:
    Terms and conditions
    Privacy policy
    © 2025 KD&A Pty Ltd
    w

    Lorem ipsum dolor sit amet, consectetur adipiscing elit eiusmod tempor

    w
    leroux@qodeinteractive.com