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Newsletter Issue No. 101
February/March 2026
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Why New Zealand, Why Now?
Qualtech has expanded into New Zealand with our 15th office, opening access to a market that combines regulatory simplicity with growing healthcare demand.
Key highlights
- No pre market approval required
- WAND database notification only, no license or registration fee
- Low entry barrier among developed markets
At the same time:
- Healthcare spending ~10% of GDP
- Ageing population driving demand
- Ongoing healthcare infrastructure investment
New Zealand offers a rare balance of accessibility today and growth potential ahead, making it a strategic entry point within APAC.
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Qualtech invites you to a free webinar on April 17, 2026, on mastering Technical Documentation under the EU Medical Device Regulation (MDR). Regulatory expert Dr. Arkan Zwick will share practical guidance on MDR documentation, Annex XVI requirements, legacy device transitions, and working with notified bodies. The session provides valuable insights for all medical device manufacturers currently active in, or planning to enter, the European market.
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This webinar recap summarizes a session organized by Qualtech on key EU MDR developments in 2026, including updated transition deadlines, EUDAMED implementation, and new requirements for Notified Bodies, along with upcoming regulatory reforms aimed at improving efficiency, transparency and innovation.
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Australia: Musculoskeletal Burden And Opportunities For Orthopedic Device Growth
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Musculoskeletal (MSK) conditions are a major health burden in Australia, ranking among the top 5 contributors to overall disease burden in 2024 and affecting nearly 7.3M people. Rising prevalence, aging demographics, and significant healthcare spending are driving growing demand for orthopedic technologies. As advanced solutions such as surgical robotics, smart implants, and regenerative therapies gain adoption, Australia's orthopedic sector continues to expand with increasing demand for innovative medical technologies.
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[Japan] Frequently Asked Questions and Tips for Identifying Raw Materials in the Application Form
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Founded in 2000 by Dr. Y.P. Chang, Qualtech Consulting Corporation now has 25 years of experience supporting medical device manufacturers worldwide. With an extensive presence across 5 continents, we are dedicated to supporting our valued clients with expertise in:
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