New Strategic Alliance with IVDEXEL: Simplified Access to the Australian Market for Medical Devices

🌏 Exciting Strategic Partnership! 🚀
We are thrilled to announce our collaboration with IVDEXEL, a leading company specializing in the registration of medical devices and in vitro diagnostic (IVD) products in Australia. This partnership strengthens our commitment to providing comprehensive and effective regulatory compliance solutions in one of the most demanding markets globally.

Through this alliance, we now have the support of local experts who excel in the requirements of the Therapeutic Goods Administration (TGA) and offer unique services, such as:
✅ Complete management of medical device and IVD registration in Australia.
✅ Sponsorship service: acting as your official representative to the TGA for a seamless market transition.
✅ Tailored technical and regulatory advice, customized to the needs of your product and business.

This partnership makes us the ideal partner to ensure the regulatory success of your products in the Australian market. 🌟

📩 Contact us to learn more and explore how we can help you expand your business in this thriving market: international@medtech-darapy.com

Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲

📝 Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲 "𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘂𝗻𝗱𝗲𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟲" 📎 The main update has been in rule 3(f) about companion diagnostics (CDx), where more examples of CDx products and products that are not considered CDx have been added. ✏️ This revision also has a flowchart […]
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DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products.
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