𝘼𝙧𝙚 𝙩𝙚𝙙𝙞𝙤𝙪𝙨 𝙧𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝙩𝙖𝙨𝙠𝙨 𝙨𝙩𝙖𝙣𝙙𝙞𝙣𝙜 𝙗𝙚𝙩𝙬𝙚𝙚𝙣 𝙮𝙤𝙪 𝙖𝙣𝙙 𝙩𝙝𝙚 𝙡𝙞𝙛𝙚𝙨𝙖𝙫𝙞𝙣𝙜 𝙞𝙣𝙣𝙤𝙫𝙖𝙩𝙞𝙤𝙣𝙨 𝙮𝙤𝙪’𝙧𝙚 𝙙𝙚𝙫𝙚𝙡𝙤𝙥𝙞𝙣𝙜? That’s where we come in. Andaman Medical has successfully registered and represents 2500+ medical devices & IVDs. Our dedicated teams handle every regulatory detail, so you can focus on what truly matters: creating products that improve lives. With Andaman Medical managing your registrations and representation, you’ll save time, reduce risks, and accelerate market access for your life-enhancing devices. Want to know how we can help you? Get in touch with us: andamanmed.com #AndamanMedical #MedicalDevices #MarketAccess #RegulatoryCompliance #ASEAN
Andaman Medical
Medical Equipment Manufacturing
Regulatory affairs and market access experts for medical devices and IVD’s in Southeast Asia
About us
Since 2013, Andaman Medical has been transforming regulatory challenges into market opportunities across Southeast Asia. Our comprehensive solutions ensure seamless market access for medical device and IVD companies worldwide. Medical Device & IVDs Registration: Our expert in-house team streamlines complex regulatory requirements through a proven fast-track process. We manage all aspects from document preparation to final approval, significantly reducing time-to-market while maintaining complete compliance. Authorized Representative Services: As your independent authorized representative, we serve as your direct liaison with regulatory authorities. Our independence offers unique flexibility in distributor relationships, ensuring you maintain full control of your licenses while we protect your interests throughout the regulatory process. Import Solutions: We navigate the intricate customs regulations in the Philippines, Indonesia, and Thailand. As license holders, we ensure efficient customs clearance and timely delivery, leveraging our deep understanding of regional trade requirements to prevent delays. Post-Market Compliance Management: Our vigilant team handles all aspects of post-market surveillance, including incident reporting, Field Safety Corrective Actions (FSCAs), and recalls. We continuously monitor regulatory changes and manage reporting obligations, keeping you fully compliant while you focus on business growth. With eight strategic offices across Southeast Asia and additional coverage in East Asia through Nord Pacific Medical, we provide comprehensive regional support. Partner with Andaman Medical to transform regulatory complexity into your competitive advantage in Asia's dynamic medical device market.
- Website
-
https://www.andamanmed.com
External link for Andaman Medical
- Industry
- Medical Equipment Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Singapore
- Type
- Privately Held
- Founded
- 2013
- Specialties
- Regulatory Affairs, Product Registration & Licensing, Clinical Affairs, Auditing, Authorized Representation, Training & Support, Business Services, Quality Management, Medical Regulatory Compliance, Regulatory Intelligence, medtech, Healthcare, Medical device, In-country Representation, Medical equipment, IVD, and Market access
Locations
Employees at Andaman Medical
Updates
-
🇮🇩 Indonesia #RegulatoryAffairs Update 1. The Indonesian Ministry of Health will carry out scheduled maintenance on the Online Licensing System for medical devices and household health products, temporarily affecting access to IDAK, statements, and other licensing processes. Find more details in our update below 👇 https://lnkd.in/g-9rgJ2a 2. The Indonesian Ministry of Health has extended the product listing period for its e-Catalogue Version 5. This extension gives manufacturers and suppliers additional time to ensure their products are included under the current catalogue version. Learn more in our update below 👇 https://lnkd.in/gpCVgHMP
-
-
𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗱𝗼𝗲𝘀𝗻’𝘁 𝗲𝗻𝗱 𝗮𝘁 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹. After your medical device or IVD enters the market, you’re expected to actively monitor its safety, manage potential risks, and respond to any issues that arise. This process is called post-market surveillance (PMS), and in Southeast Asia, it's a critical part of maintaining compliance. If not managed properly, post-market obligations can lead to: ⛔ Regulatory penalties ⛔ Product recalls or license suspension ⛔ Lasting damage to brand reputation At Andaman Medical, we support you with: ✅ Post-market surveillance and safety monitoring ✅ Adverse event reporting to local authorities ✅ Recall planning and coordination ✅ Ongoing updates on regulatory changes We help ensure your device remains compliant, safe, and available across Southeast Asia. 👉 Learn more at andamanmed.com #AndamanMedical #RegulatoryCompliance #PostMarketSurveillance #MedicalDevices #IVD #MarketAccess #MedTech #ASEAN #HealthcareInnovation
-
🎉 𝗖𝗲𝗹𝗲𝗯𝗿𝗮𝘁𝗶𝗻𝗴 𝗮 𝗠𝗮𝗷𝗼𝗿 𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲! We are delighted to congratulate Nord Pacific Medical on their instrumental role in the certification of an innovative AI Solution in Hong Kong, which was completed faster than expected! This achievement underscores the power of collaboration and our shared commitment to advancing healthcare through cutting-edge innovation. At Andaman Medical, we understand the significance of efficiently navigating regulatory landscapes, and this accomplishment is a testament to the impact of trusted partnerships in driving success. We look forward to seeing all the positive changes this will bring to Hong Kong’s healthcare system. Here’s to continued success and innovation ahead!
𝗥𝗲𝗰𝗼𝗿𝗱-𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴 𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲 𝗔𝗰𝗵𝗶𝗲𝘃𝗲𝗱! We’re thrilled to celebrate the successful medical device certification of an AI Solution in Hong Kong, and the entire process was completed faster than we expected! 🎉 At Nord Pacific Medical, we’re proud to have played a key role throughout this journey. This swift and successful certification highlights the strength of our collaboration and our mutual dedication to innovation and excellence. Beyond regulatory compliance, this accomplishment highlights what can be achieved through trusted partnerships and united expertise. Thank you, AITRICS, for your faith in us. We’re excited to see your AI Solution making a meaningful impact in Hong Kong’s healthcare system, and we look forward to future successes together. #NordPacificMedical #AITRICS #VitalCare #MedicalAI #MedicalDevices #RegulatorySuccess #MarketAccess #HongKongHealthcare #MedTechAsia #PatientSafety #DigitalHealth #RegulatoryAffairs #GlobalExpansion
-
-
🇲🇾 Malaysia #RegulatoryAffairs Update 1. The Malaysian Medical Device Authority (MDA) has released the Third Edition Guidance Document (MDA/GD/0063) on Harmonised Borderline Products in ASEAN, clarifying product definitions and regulatory status across the region as of June 2025. Learn more in our update below 👇 https://lnkd.in/g6e77USJ 2. The Malaysian Medical Device Authority (MDA) has released the Third Edition Guidance Document (MDA/GD/0062) on the ASEAN‑harmonised classification of medical devices, issued in June 2025. This update aligns device risk classification with the ASEAN Medical Device Directive, streamlining regulatory consistency and transparency across the region. Find more details in our update below 👇 https://lnkd.in/ggQCwAnF 3. The Malaysian Medical Device Authority (MDA) has introduced a new login feature via MyDigital ID on the MedC@St 2.0+ portal, effective 23 June 2025. This optional Single Sign-On enhancement strengthens user security with two-factor verification and alignment with national digital ID standards. Logging in via MyDigital ID is highly encouraged for a safer, more seamless experience. Get the full details in our update below 👇 https://lnkd.in/gATfTaJt
-
-
The WHO South-East Asia hybrid workshop to improve the regulation of medical devices highlights the growing importance of regional collaboration in shaping the future of health policy. At Andaman Medical, we work hand-in-hand with MedTech companies to stay ahead of these changes. Our team actively monitors policy shifts and regulatory developments across Southeast Asia to help businesses remain compliant, reduce time to market, and ultimately bring safe, effective innovations to patients faster. Want to keep pace with the region’s evolving regulatory landscape? Follow us for timely insights, or contact us to receive Regulatory Intelligence Briefings tailored to your product type and target markets. #AndamanMedical #RegulatoryCompliance #MedicalDevices #HealthcareSystems #SouthEastAsia
In a message to Regional Hybrid Workshop to Improve Regulation of Medical Devices, Regional Director Saima Wazed reiterated WHO’s commitment to give long-deserved attention to regulation of life-enabling and life-saving products.
-
-
🇲🇾 Malaysia #RegulatoryAffairs Update The Malaysian Medical Device Authority (MDA) has introduced an enhanced dispute resolution process for medical device classification, enabling manufacturers and conformity assessment bodies to resolve classification disagreements more efficiently and transparently. Find more details in our update below 👇 https://lnkd.in/eucsGs7a
-
-
📣 𝗪𝗲'𝗿𝗲 𝗛𝗶𝗿𝗶𝗻𝗴: 𝗟𝗲𝗴𝗮𝗹 𝗖𝗼𝘂𝗻𝘀𝗲𝗹 📍 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: 𝗚𝗲𝗼𝗿𝗴𝗲𝘁𝗼𝘄𝗻, 𝗣𝗲𝗻𝗮𝗻𝗴 𝗪𝗲'𝗿𝗲 𝗲𝘅𝗰𝗶𝘁𝗲𝗱 𝘁𝗼 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲 𝗮𝗻 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼 𝗷𝗼𝗶𝗻 𝗼𝘂𝗿 𝗴𝗿𝗼𝘄𝗶𝗻𝗴 𝘁𝗲𝗮𝗺 𝗮𝘁 𝗔𝗻𝗱𝗮𝗺𝗮𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹! If you're a legal professional with a sharp eye for detail, a proactive mindset, and a passion for navigating complex legal matters in a dynamic, fast-evolving environment—we want to hear from you. As Legal Counsel, you’ll play a key role in supporting our operations across Southeast Asia and beyond, ensuring compliance, managing risk, and contributing to strategic decisions. At Andaman Medical, we value integrity, growth, and teamwork. If you're looking to make a meaningful impact and grow your career with a purpose-driven company, apply today! 📩 𝗦𝗲𝗻𝗱 𝘆𝗼𝘂𝗿 𝗖𝗩 𝘁𝗼: 𝗚𝗲𝗻𝗲𝗿𝗮𝗹𝗛𝗥@𝗮𝗻𝗱𝗮𝗺𝗮𝗻𝗺𝗲𝗱.𝗰𝗼𝗺
-
𝗘𝗻𝘁𝗲𝗿𝗶𝗻𝗴 𝗦𝗼𝘂𝘁𝗵𝗲𝗮𝘀𝘁 𝗔𝘀𝗶𝗮’𝘀 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗺𝗮𝗿𝗸𝗲𝘁? It’s not just about submitting documents and waiting for approval. Each country in the region follows a multi-step regulatory process, from product classification and dossier preparation to post-market surveillance. Missing even one step can cause major delays or jeopardise your launch altogether. At Andaman Medical, we guide you through every stage of the registration lifecycle. Our local teams ensure you meet country-specific requirements, avoid bottlenecks, and stay compliant throughout. Ready to navigate the full journey with confidence? Subscribe to our newsletter for regular updates, insights, and expert tips on medical device registration: https://lnkd.in/g9_THbAm #AndamanMedical #MedicalDevices #MarketAccess #ASEAN #RegulatoryCompliance #MedTech #MedicalDeviceRegistration #IVD #HealthcareInnovation #PostMarketSurveillance
Subscribe to our newsletter for regular updates, insights, and expert tips on medical device registration
-
Building Stronger MedTech Pathways Together 🇹🇼🌏 As a Patron Member of TMBIA, Andaman Medical is honoured to partner with one of the region’s most influential medtech associations to advance regulatory excellence. During our recent exclusive seminar for TMBIA members, Southeast Asia Medical Device Regulations: Latest Management & Post-Market Requirements, we shared expert perspectives on navigating regulatory complexities and meeting post-market demands. Our partnership with TMBIA reflects our long-term commitment to supporting Taiwan’s manufacturers as they pursue regional expansion and highlights our role as a trusted regulatory ally in Southeast Asia. This seminar marks the beginning of our collaboration with TMBIA. We look forward to empowering Taiwan manufacturers with actionable insights and ongoing support to navigate Southeast Asia’s evolving regulatory landscape. #AndamanMedical #TMBIA #AsiaPacific #MarketAccess #RegulatoryAffairs #MedicalDevices #HealthcareInnovation #TaiwanMedTech #MedTechLeadership #SoutheastAsia