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KD&A - Regulatory Consultants for Medical and IVD devices

kdent@kdas.com.au
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  • About Us
    • About Us
    • What our Clients Say
    • Frequently Asked Questions
  • Our Services
    • Medical Device Regulatory Strategy
    • ISO 13485/ MDSAP QMS Maintenance, Internal Audit and Support
    • Technical File Documentation
    • Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
    • Post Market Surveillance
    • TGA Conformity Assessment / CE Marking
    • Promotional Materials Review
    • Australian TGA Sponsor Services
    • Medical Device and IVD Classification Assessment
    • Software as a Medical Device (SaMD)
  • Our Clients
    • Australian Sponsors & Distributors
    • Medical Device Manufacturers
    • International Medical Device Manufacturers
    • Our Clients
  • News
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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 Maintenance, Internal Audit and Support
    • Technical File Documentation
    • Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
    • Post Market Surveillance
    • TGA Conformity Assessment / CE Marking
    • Promotional Materials Review
    • Australian TGA Sponsor Services
    • Medical Device and IVD Classification Assessment
    • Software as a Medical Device (SaMD)
  • Our Clients
    • Australian Sponsors & Distributors
    • Medical Device Manufacturers
    • International Medical Device Manufacturers
  • Latest News
  • Contact Us

June 2014

30
Jun
TGA

TGA Fees & Timeframes – MTAA White Paper Bares All

The Medical Technology Association of Australia (the MTAA) has released a white paper on the regulatory burdens medical device companies face in Australia. They key focus of the pa

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27
Jun
Regulatory Changes

Medical Devices in Malaysia – Tips to Master Market Access!

Malaysia has a well established regulatory system for medical devices governed by the Health Sciences Authority (HSA). The market has a reputation for being difficult to enter from

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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

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11
Jun
TGA

TGA Product Registration – KD&A’s Tips and Tricks

If you wish to sell medical devices in Australia, the Therapeutic Goods Administration (TGA) require you to include the device on the Australian Register for Therapeutic Goods (ART

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Latest Articles
March 20, 2025
Understanding Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal Origin Substances
February 13, 2025
TGA Recall Reforms: A Closer Look at the PRAC
December 6, 2024
KD&A Can Help You From the Start – Medical Devices Steps to Market
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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:
    Level 3, Suite 301,
    27 Belgrave Street,
    Manly NSW, Australia
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    © 2025 KD&A Pty Ltd
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