Navigate the Medsafe registration process with confidence. We guide you from initial classification to market placement, with expert consulting, documentation support, and in-country representation.
Your Regulatory Journey
Every medical device follows a product life cycle. Here’s how we support you at each stage on your way to Asia submission in Asia.
You are at the beginning of your medical device journey in New Zealand. We help you understand whether your product falls under Medsafe rules, how to define its intended use, and what the first regulatory decisions mean for WAND notification, sponsor responsibilities and market access.
Your company is taking shape. We help you answer the first regulatory questions, classify your device, identify applicable standards and build a practical route towards Medsafe compliance and international readiness.
Before development starts, we help you prepare the regulatory and quality foundation for your New Zealand medical device project. We review your strategy, quality system, technical documentation and resource setup so your next steps are clear and controlled.
Define intended purpose, user requirements, and design inputs aligned with the requirements of your priority markets. We make sure your technical file foundation supports efficient submissions.
Assess feasibility per market. We evaluate clinical evidence needs, equivalence routing, regulatory expectations, and which markets are realistic in your timeline and budget.
During development we support specification, usability engineering, software validation, risk management, verification and validation, with regulatory planning built into the process.
Transition from design to production. We ensure your IQ, OQ, PQ processes are ready, technical documentation is complete, and country-specific dossiers can be assembled efficiently from a common core.
Review your quality system, prepare for audits, and keep improving after submission. We help you stay inspection-ready and make sure weak points are found before they become problems.
We help you meet local representation requirements so your device can be placed on the market with the right legal partner in place.
We support your market entry pathway and guide you through the registration steps, documentation needs and authority expectations.
After launch, we help you keep your device compliant, monitor real-world performance and respond correctly when incidents or field actions occur.
Expand your reach. We help you enter additional markets, reuse your documentation where possible and adapt your regulatory strategy where needed.
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