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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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March 2026

12
Mar
Regulatory ChangesSoftwareTechnologyTGA

TGA Compliance Principles 2026–2027: What the Update Means for Industry

Recent Regulatory Update In January 2026, the Therapeutic Goods Administration (TGA) released its Compliance Principles for 2026–2027, outlining how the regulator intends to moni

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Latest Articles
August 25, 2026
Are You Ready for a TGA Post-Market Review? Post-Market Surveillance (PMS) Obligations for Australian Sponsors
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
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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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