Keeping up with changing regulations in Southeast Asia can be challenging, but Andaman Medical makes it easier. Our team of local experts, based in offices across the region, monitors regulatory updates daily. We stay in close contact with national authorities, ensuring you have the latest information to keep your medical devices compliant and ready for market. 👉 Learn more: https://andamanmed.com/
Andaman Medical
Pembuatan Peralatan Perubatan
Regulatory affairs and market access experts for medical devices in Southeast Asia
Perihal kami
Andaman Medical is a global pioneer in the field of regulatory services, working tirelessly since 2013. We ensure the seamless execution of key processes for medical device registration, independent authorized representatives, importation, and managing post-market compliance in Southeast Asia. Our focus is providing you with a hassle-free experience, so you can concentrate on what you do best - innovating and advancing your medical devices. With our comprehensive services, we take care of the red tape, enabling you to expedite your entry into new markets. * Medical Device Registration: Our experts navigate the intricacies of medical device registration, eliminating challenges and mitigating risks associated with getting your medical device approved. * Authorized Representative: We act as your third-party authorized representative, liaising with regulatory authorities on your behalf, ensuring your interests are always protected. * Importation: Navigating the complex maze of import regulations can be daunting. We take this burden off you, ensuring your products move smoothly through customs and reach their destination on time. * Post Market Compliance: Keeping up with post-market requirements & updates in regulations can be time-consuming and complex. We offer you peace of mind ensuring you stay ahead of the game and avoid regulatory pitfalls. We're your strategic partner with in-house expertise, prompt communication, and innovative solutions that save you time and resources. Since opening our office in 2013, we have established ourselves as a leading provider of regulatory services, exclusively on medical devices. We're committed to upholding the highest standards of professionalism and integrity, and our proven track record speaks to this commitment. Experience the Andaman Medical difference - where your success is our mission. We invite you to reach out today and see how we can assist you in navigating the medical device regulatory landscape.
- Laman web
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http://www.andamanmed.com
Pautan luaran untuk Andaman Medical
- Industri
- Pembuatan Peralatan Perubatan
- Saiz syarikat
- 51-200 pekerja
- Ibu pejabat
- Singapore
- Jenis
- Milik Persendirian
- Ditubuhkan
- 2013
- Pengkhususan
- 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, Market access
Lokasi
Pekerja di Andaman Medical
Kemas Kini
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Vietnam 🇻🇳 #RegulatoryAffairs Update: Vietnam’s Ministry of Health has released draft amendments and supplements to the Decree on medical device management. These changes aim to streamline processes and address key regulatory challenges for manufacturers, importers, and distributors. Find out more details in our update below 👇
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Indonesia 🇮🇩 #RegulatoryAffairs Update: The Indonesian Ministry of Health has issued guidance classifying dried blood spot products as medical devices. This classification affects manufacturers, importers, and distributors, who must now ensure compliance with medical device regulations in Indonesia. Find out more details in our update below 👇
Indonesia: Notification of Dried Blood Spot Product Classification as a Medical Device
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🌟 Here’s to a New Year of Opportunities!🌟 Happy New Year from all of us at Andaman Medical! In 2024, we achieved incredible milestones together, and we’re looking forward to even greater accomplishments in 2025. Here’s to another year of advancing healthcare and making a difference together. May the new year bring you success, health, and happiness! #AndamanMedical #MedicalDevices #BusinessExpansion #Healthcare #SoutheastAsia #MarketGrowth #RegulatoryAffairs
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Vietnam 🇻🇳 #RegulatoryAffairs Update: The MOH in Vietnam has eliminated the regulations on manufacturers' codes and medical supplies encoding, easing the regulatory process for medical devices. Find out more details in our update below 👇
Vietnam: MoH Abolishes Regulations on Manufacturer’s Codes and Medical Supplies Encoding
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Thailand 🇹🇭 #RegulatoryAffairs Update: Thailand has provided clarification on vehicles and medical equipment products classified as medical devices. This clarification aims to help manufacturers and importers ensure compliance with the Medical Device Act. Find out more details in our update below 👇
Thailand: Clarification on Vehicles and Medical Equipment Products as Medical Devices
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Vietnam 🇻🇳 #RegulatoryAffairs Update: The Ministry of Health in Vietnam has promulgated a detailed list of medical devices with assigned Harmonized System codes, simplifying trade and regulatory processes for medical device companies. Find out more details in our update below 👇
Vietnam: MoH Promulgates List of Medical Devices with Assigned Harmonized System Codes
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Vietnam 🇻🇳 #RegulatoryAffairs Update: Vietnam’s Ministry of Health (MOH) has issued a notice regarding medical devices with import licenses expiring on December 31, 2024. Manufacturers and importers are advised to renew their licenses before the deadline to ensure continued compliance. Find out more details in our update below 👇
Vietnam: MoH Issues Notice on Medical Devices with Import Licenses Expiring December 31, 2024
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Looking to expand your medical device business? Southeast Asia offers incredible growth opportunities 📈, thanks to: - Rapid Market Growth: The Asia-Pacific medical device market is projected to surpass $225 billion by 2030, with Southeast Asia leading the charge. - Large & Growing Population: The 6 major ASEAN markets—Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam—are home to over half a billion people, offering a vast customer base. - Rising Middle Class: By 2030, 65% of the population will be part of the middle class, driving demand for higher-quality healthcare. - Low Market Penetration: With medical devices still underpenetrated, there are endless opportunities for growth. - Government Support & Trade Agreements: Countries like Malaysia are heavily investing in healthcare infrastructure, and regional trade agreements like RCEP are facilitating easier market access. Ready to explore the opportunities in Southeast Asia 🌏? Get in touch with us today at https://lnkd.in/esPbg-ye #AndamanMedical #SoutheastAsia #regulatoryservice #medicaldeviceregistration #IVDregistration #postmarketsurveillance
Ready to explore the opportunities in Southeast Asia? Get in touch with us today