Andaman Medical

We’ve got some exciting news! 🎉 Andaman Medical is thrilled to announce the opening of our new Malaysia 🇲🇾 office. Same great team, same mission—now with more room to grow! Take a sneak peek at our fresh new space! Ready to take on Southeast Asia with us? Start here! https://lnkd.in/esPbg-ye #AndamanMedical #Malaysia #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

Over the years, I’ve learned that navigating regulatory requirements in Southeast Asia is no easy task. Medical device manufacturers need to: ➡️ Manage Different Regulatory Frameworks Navigating multiple regulatory authorities, unique rules, procedures, and timelines for medical device registration. ➡️Overcome Language Barriers Southeast Asia often requires communication with local authorities and documentation in local languages. Without this, your approval process can face serious delays. ➡️Work Around Non-standardised Regulation Unlike Europe, Southeast Asia does not have a unified regulatory framework across its countries. This makes managing compliance across ASEAN more complex. ➡️Understand Post-Market Surveillance and Compliance This includes reporting adverse events, conducting regular audits, and ensuring ongoing compliance with changing regulations. ➡️ Consider Cultural Differences and Business Practices Understanding local business cultures is essential for success. Negotiation styles, decision-making processes, and the pace of business can vary significantly across Southeast Asia. At Andaman Medical, we don’t just handle product registration—we provide the critical insights and guidance needed to avoid delays and compliance issues. From product registration to post-market surveillance and regulatory updates, we’re here to help you navigate these challenges. Ready to expand? Start here to see how Andaman Medical can support your journey. https://lnkd.in/ghGsaw8G

Navigating Cambodia’s medical device market can be complex, but Andaman Medical makes it seamless. We offer end-to-end services, including: 1. Independent License Holding 2. Medical Devices and IVDs Registration 3. Post Market Surveillance and Compliance With an in-house team of regulatory experts in Cambodia and over 2,000 successful device registrations across Southeast Asia, we ensure faster communication, compliance, and long-term regulatory oversight. As an independent authorised representative, we can hold product licences on your behalf, giving you the flexibility to choose your distributors freely without impacting your product registrations. Let us guide you through the entire market entry process in Cambodia. Learn more: https://lnkd.in/ewVD5VCD #AndamanMedical #Cambodia #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

With Singapore's medical device market projected to grow from $3.23 billion in 2023 to $7.11 billion by 2033*, there's no better time to enter this thriving market. Andaman Medical offers comprehensive, end-to-end support, including: 1. Independent License Holding 2. Medical Devices and IVDs Registration 3. Post Market Surveillance and Compliance Work with a single, trusted partner for the entire process. With locally employed regulatory experts in Singapore, we have the expertise, local language skills, and industry relationships to ensure smooth market entry and compliance. Plus, we're ISO 13485:2016 certified, aligning with the highest standards in medical device quality management. Learn more about how we can help: https://lnkd.in/e_AtuRAz #AndamanMedical #Singapore #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

With Singapore's medical device market projected to grow from $3.23 billion in 2023 to $7.11 billion by 2033*, there's no better time to enter this thriving market. Andaman Medical offers comprehensive, end-to-end support, including: 1. Independent License Holding 2. Medical Devices and IVDs Registration 3. Post Market Surveillance and Compliance Work with a single, trusted partner for the entire process. With locally employed regulatory experts in Singapore, we have the expertise, local language skills, and industry relationships to ensure smooth market entry and compliance. Plus, we're ISO 13485:2016 certified, aligning with the highest standards in medical device quality management. Learn more about how we can help: https://lnkd.in/e_AtuRAz #AndamanMedical #Singapore #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

Registering medical devices in Thailand? All products need Thai FDA approval via the "E-submission system". Foreign manufacturers can: 1. Set up a Thai subsidiary 2. Appoint a licensed local distributor 3. Partner with Andaman Medical, holding a certified Establishment License We guide you through licensing and registration, ensuring smooth market entry. Let us navigate Thai regulations while you focus on innovation. Learn more: https://lnkd.in/e8Yfd7Tv #AndamanMedical #Thailand #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

✨🪔 Sparkling wishes for a radiant Deepavali! 🪔✨ Happy Deepavali from all of us at Andaman Medical. May this Festival of Lights illuminate your life with vibrant health, boundless happiness, and endless prosperity. Stay glowing and safe as you celebrate! #AndamanMedical #deepavali2024 #diwali2024

Andaman Medical supports your medical device compliance journey from start to finish. We manage comprehensive post-market surveillance for medical devices in Thailand, including adverse event and FSCA reporting, timeline compliance, direct FDA communication, and online submissions through official systems. From registration to submission, Andaman Medical ensures your medical device stays fully compliant. 👉 Find out more about how we can support you: https://lnkd.in/g3Xh_AX6 #AndamanMedical #Thailand #regulatoryservice #postmarketsurveillance #regulatoryservice #medicaldeviceregistration #IVDregistration

Thailand 🇹🇭 #RegulatoryAffairs update: The Thai FDA released updated guidelines on medical device labeling, covering both home-use and professional-use devices. These guidelines provide detailed instructions on the required language, content, and clarity for labels, along with new requirements for attaching labels to packaging. Find out more details in our update below 👇 #AndamanMedical #Thailand #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance

🤝 We’re thrilled to announce a groundbreaking partnership with Korea Testing & Research Institute (KTR), marking a significant step in advancing regulatory support for medical device and in-vitro diagnostic (IVD) companies across Asia. This collaboration streamlines access to essential resources, testing, and market entry, enabling clients to navigate complex regulatory landscapes. With expert registration and representation across seven ASEAN countries—Indonesia, Malaysia, Vietnam, Thailand, the Philippines, Singapore, and Cambodia—innovative devices can now reach Southeast Asia faster. Mourad Kholti, CEO of Andaman Medical, shares, “Our collaboration bridges Korean medical innovation with Southeast Asia, enhancing healthcare outcomes and fostering economic growth across the region.” He envisions a thriving ecosystem of medical innovation and stronger healthcare ties between Korea and Southeast Asia. With Andaman Medical’s expertise and KTR’s resources, we’re ready to help Korean manufacturers bring their innovations to Southeast Asia, improving patient access to advanced care while supporting local regulatory needs. #AndamanMedical #KoreaTestingResearchInstitute #MedicalDeviceRegistration #IVDRegistration #RegulatoryServices #InnovationInHealthcare #ASEAN