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  • Home
  • About Us
  • Our Team
  • Services & Expertise
    • Strategy Planning
    • Product Development and Standards
    • Regulatory Submissions
    • Re-scheduling / Re-classification Services
    • Postmarket Compliance & Surveillance
    • Regulatory and Administrative Appeals
    • Literature-Based Medicine Submissions
    • Biosimilar & Biotechnology Medicine Development
    • Due Diligence and Technical Assessment
    • Quality Management Systems
    • Authorised Representation, Sponsorship & Distribution Management
    • Reimbursement – Strategy, Advice and Submissions
    • Distribution Services
    • Diagnostics and IVDs
    • Biocompatibility
  • News and Articles
  • Events
  • Videos
  • Contact Us

News and Articles

3D Printing of Hand

Transition plan from Custom device to Patient-matched

February 11, 2021 | | Jean Boudaud
Vaccine and Vial

Provisionally yours

January 27, 2021 | | Grant Bamde
Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

January 22, 2021 | | Jenny Lin

EUDAMED is LIVE

December 15, 2020 | | Jean Boudaud

MD Regulatory transition under Brexit

December 15, 2020 | | Jean Boudaud
Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

November 26, 2020 | | Luis Jimenez

Formulated ingredients and premixes: Keeping the IP of a PI

November 24, 2020 | | Nicole Tan
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

November 19, 2020 | | Homi Dalal
Taipei, Taiwan

Upcoming update to the Taiwan FDA Medical Devices Act

November 2, 2020 | | Jenny Lin

TGA deploys Post Market Review Compliance Dashboard

October 29, 2020 | | Homi Dalal
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Brandwood CKC is the premier regulatory, quality systems and reimbursement consultancy in Australia serving local and international healthscience innovators for more than 20 years.

ABN: 61 128 762 505

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