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As Southeast Asia’s healthcare market continues to expand, Thailand and Vietnam offer significant opportunities for medical device manufacturers. Successfully entering these markets requires more than just regulatory approval—it demands a clear understanding of local regulations, culture, and stakeholder dynamics to ensure your device reaches the right hands safely and compliantly. CMS SciDoc acts as your trusted Local Authorised Representative (LAR) in Thailand and Vietnam, supporting you from initial registration to post-market surveillance and ongoing regulatory compliance. Our Services Include:💠 Registration with Thai FDA & Vietnam MOH💠 Vigilance, incident reporting & post-market surveillance💠 Continuous regulatory updates & compliance guidance💠 Legal representation & liaison with health authorities💠 Strategic insights to drive long-term[…]

Regulatory compliance doesn’t end once your medical device enters the market. Sponsors are required to continuously monitor product performance, manage complaints, report adverse events, and maintain up-to-date documentation to stay compliant and audit-ready. At CMS SciDoc, we help TGA sponsors manage post-market requirements with confidence. Our support includes: • Adverse event and vigilance reporting (MDR)• Complaint handling processes• CAPA management• Post-Market Surveillance (PMS) documentation• Annual reporting obligations• Technical documentation maintenance• Ongoing regulatory compliance support Let our experts simplify your post-market compliance workload and reduce regulatory risk. Book a free consultation with CMS SciDoc today and stay ahead of your obligations.

Unlock expert-level mastery of ISO 13485:2016 with our intensive Two-Day Workshop, crafted specifically for professionals in medical devices who demand excellence in quality management, compliance, and patient safety.​ 🔍 What You’ll Gain – In-Depth Learning Outcomes:✅ Core Purpose & Impact: Explore why ISO 13485 is the global benchmark for medical device QMS, its role in risk-based thinking, and how it drives continuous improvement across design, production, and distribution.​ ✅ Clause-by-Clause Mastery: Detailed walkthrough of all key clauses – from leadership commitments and resource planning to design controls, supplier management, and post-market surveillance – with real-world case studies and examples.​ ✅ Practical Implementation Toolkit: Hands-on guidance for applying the standard, including process mapping, risk[…]

Regulatory approval isn’t optional — and having a qualified local representative is essential for market access and ongoing compliance. At CMS SciDoc, we specialize in providing Professional Local Representation Services to ensure smooth regulatory compliance and successful product registration in both markets: 💠 🇦🇺 Australia – TGA ComplianceOfficial Australian Sponsor – supporting submissions, ARTG inclusion, and communication with the Therapeutic Goods Administration. 💠🇳🇿 New Zealand – Medsafe ComplianceAuthorized NZ Agent – managing regulatory liaison and maintaining your ongoing obligations with Medsafe. Our end-to-end services include:✔ Regulatory submissions & ARTG inclusion✔ Post-market surveillance & adverse event reporting✔ Direct liaison with TGA & Medsafe✔ Support for Class I–III and IV medical devices 🔒 Stay compliant🚀 Accelerate market entry Contact us today to[…]