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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
    • 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
  • Useful Links

Kenya Tag

19
Mar
Regulatory Changes

An Insight Into Medical Device Requirements in Kenya

The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The docum

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Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B
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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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