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
Andaman Medical
医疗设备制造业
Regulatory affairs and market access experts for medical devices in Southeast Asia
关于我们
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.
- 网站
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https://www.andamanmed.com
Andaman Medical的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 51-200 人
- 总部
- Singapore
- 类型
- 私人持股
- 创立
- 2013
- 领域
- 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和Market access
地点
Andaman Medical员工
动态
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Vietnam ???? #RegulatoryAffairs update: The Ministry of Health in Vietnam has issued a new circular mandating price declarations for specific medical devices. This regulation aims to enhance transparency and ensure fair practices in the healthcare sector. Find out more details in our update below ??
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Join us for the OMETA Healthcare Seminar on 10 December 2024! Gain valuable insights into the latest trends and strategies in healthcare, and learn how Andaman Medical can support your journey in launching medical devices and IVDs across Southeast Asia. ?? Date: 10 December 2024 ?? Time: 2:30 PM to 4:20 PM JST (5:30 AM to 7:20 AM CET)(12:30 PM to 2:20 PM SGT) ?? Location: Online (Zoom) Register at [email protected] to save your seat. Let’s connect and explore opportunities together! #OMETAHealthcareSeminar #MedicalDevices #IVD #SoutheastAsia #HealthcareInnovation #NordPacificMedical
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EU MDR & IVDR Webinar: What It Means for Southeast Asia ?? Join Andaman Medical’s experts to explore the latest MDR & IVDR updates and their Southeast Asian implications. ?? Event Details: Date: Monday, November 25, 2024 Time: 3.00 PM to 4.30 PM Singapore Time (SGT), 8:00 AM to 10:30 AM Central European Time (CET) Topic: EU MDR & IVDR - How This Affects the Southeast Asia Market What to Expect: ? Break Down MDR & IVDR Updates Learn the latest changes and how they affect your product compliance. ? Smooth Transition Tips Understand critical timelines and step-by-step guidance for compliance. ? Regional Market Insight Discover how Southeast Asian markets are adapting to new regulations and what it means for you. ? Direct Q&A with Experts Connect with Andaman Medical’s experts and get your questions answered in real-time. Turn compliance into your competitive advantage! ?? Reserve Your Spot Now : https://lnkd.in/gAShuJM4 #AndamanMedical #webinar #MedicalDevices #RegulatoryAffairs #MarketAccess #IndustryUpdates #SoutheastAsia #HealthcareCompliance
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We’re heading to Taiwan! ?? Nord Pacific Medical is thrilled to announce our participation in Healthcare Expo Taiwan from 5-8 December 2024 at the Taipei Nangang Exhibition Center. We’re excited to share our expertise on entering the Southeast Asia market. Stop by our booth to learn how Andaman Medical and Nord Pacific Medical can help you navigate complex regulatory landscapes and accelerate your market entry. ?? Mark your calendars ?? Location: Taipei Nangang Exhibition Center (Booth: N1029) ?? Let’s connect, discuss your goals, and explore how we can support your success in the Southeast Asian healthcare market. #HealthcareExpoTaiwan #MedicalDevices #IVD #SoutheastAsia #RegulatoryAffairs #MarketEntry #NordPacificMedical
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At Andaman Medical, we do more than just help you navigate the regulatory process—we enable your business to thrive in Southeast Asia with: ? Fast, Safe Market Entry ? Local Expertise ? Flexible Distribution ? Seamless Regulatory & Commercial Success ? Proven Track Record Concentrate on improving healthcare, while we handle the regulatory complexities for you. Get in touch with us today to learn more: https://andamanmed.com/ #AndamanMedical #SoutheastAsia #RegulatoryAffairs #MedicalDevices #IVDregistration #MarketEntry #Compliance
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Indonesia ???? #RegulatoryAffairs update: The Indonesian Ministry of Health has announced the deactivation of the Electronic Catalogue System Version 5. This new directive outlines updated procedures and requirements for medical device procurement in Indonesia, emphasizing compliance and operational efficiency. Find out more details in our update below ??
Indonesia: Deactivation of the Electronic Catalogue System Version 5
https://andamanmed.com
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Thailand ???? #RegulatoryAffairs update: The Thai FDA has released a draft announcement concerning medical device advertising licenses. This new guidance outlines the requirements and responsibilities for companies aiming to advertise medical devices in Thailand Find out more details in our update below ??
Thailand: A Draft TFDA Announcement on Medical Device Advertising Licenses by the Thai FDA
https://andamanmed.com
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EU MDR & IVDR Webinar: What It Means for Southeast Asia ?? Join Andaman Medical’s experts to explore the latest MDR & IVDR updates and their Southeast Asian implications. ?? Event Details: Date: Monday, November 25, 2024 Time: 3.00 PM to 4.30 PM Singapore Time (SGT), 8:00 AM to 10:30 AM Central European Time (CET) Topic: EU MDR & IVDR - How This Affects the Southeast Asia Market What to Expect: ? Break Down MDR & IVDR Updates Learn the latest changes and how they affect your product compliance. ? Smooth Transition Tips Understand critical timelines and step-by-step guidance for compliance. ? Regional Market Insight Discover how Southeast Asian markets are adapting to new regulations and what it means for you. ? Direct Q&A with Experts Connect with Andaman Medical’s experts and get your questions answered in real-time. Turn compliance into your competitive advantage! ?? Reserve Your Spot Now : https://lnkd.in/gAShuJM4 #AndamanMedical #webinar #MedicalDevices #RegulatoryAffairs #MarketAccess #IndustryUpdates #SoutheastAsia #HealthcareCompliance