December Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices and IVD’s in Southeast Asia
Hey there,?
Welcome to 2025! ?? As we kick off the new year, we’re here to help you navigate the opportunities and challenges ahead in the dynamic Southeast Asian medical device regulatory landscape.
This month’s highlights are packed with everything you need to stay ahead.?
What’s Inside This Month’s Newsletter??
?? Event Highlights: Relive December’s key moments, featuring valuable insights from our webinars and trade show successes.
??Upcoming Event: Mark your calendars!? Join us for our upcoming FREE webinar, "Navigating Vietnam's Medical Device Regulatory Pathway," this February. More details below!
?? Regulatory Updates: Stay informed with the latest compliance changes across Southeast Asia.
?? 2025 Trends: Discover the innovations and regulatory shifts shaping the medical device industry this year.
?? Let’s dive in and set the stage for an exceptional 2025!
December Event Highlights ??
?? Healthcare Expo Taiwan 2024?
Thank you for visiting Nord Pacific Medical and Andaman Medical during Healthcare Expo Taiwan 2024!
We hope you enjoyed learning about navigating Southeast Asia’s medical markets and gained valuable insights into regulatory compliance, product approvals, and market entry strategies.
If you have further questions or would like to continue the conversation, don’t hesitate to reach out to us at? https://andamanmed.com/contact-us/
Looking forward to collaborating with you!
?? OMETA Healthcare Seminar 2024
Nord Pacific Medical , the newest expansion of Andaman Medical, hosted the insightful seminar with industry leaders, diving deep into the latest trends in medical devices and global market opportunities.?
From Japan-Taiwan trade collaborations to Southeast Asia’s compliance strategies, we hope the discussions provided you with actionable insights and valuable takeaways to support your business goals.
Your participation made this event a success, and we are grateful for your time and engagement.?
We look forward to connecting with you again as we continue driving innovation in the healthcare industry. ??
?? Southeast Asia Medical Device Market Entry Seminar and Panel Discussion?
We want to extend our heartfelt thanks to everyone who joined us on 12th December at AP Tokyo Marunouchi for our seminar and panel discussion focused on the medical device market in Southeast Asia.
The exclusive event, hosted by Nord Pacific Medical and sponsored by Andaman Medical, offered a comprehensive overview of medical device regulations in countries such as Singapore, Malaysia, the Philippines, Indonesia, Thailand, Vietnam, and Cambodia. Attendees also gained valuable insights into navigating regulatory challenges and strategies for successful market entry through expert-led discussions and panel sessions.
We hope you left with actionable insights to confidently approach the dynamic Southeast Asian medical device market.
For those who couldn’t make it or if you have further questions, feel free to reach out to us at https://nordpacificmed.com/contact-us/.
Looking forward to more conversations and collaborations ahead!
What’s Next??
??? FREE Webinar: Navigating Vietnam's Medical Device Regulatory Pathway?
Ready to enter Vietnam’s medical device market? Join our exclusive webinar, hosted by Andaman Medical and Nord Pacific Medical.?
Our experts? break down Vietnam’s regulatory framework step-by-step. Learn how to navigate registration processes, compliance requirements, and recent regulatory updates to ensure smooth market entry.?
Stay tuned for registration details!
领英推荐
Regulatory Update???
Indonesia ???? ?
The Indonesian Ministry of Health has announced a temporary closure of its medical device licensing and online certification systems. This suspension is part of ongoing system upgrades to enhance efficiency. Learn how this affects licensing processes and what steps businesses can take to prepare. Indonesia Classifies Dried Blood Spot Products as Medical Devices
The Indonesian Ministry of Health has officially classified dried blood spot products as medical devices, impacting regulatory requirements for manufacturers and distributors. Discover what this means for manufacturers and how to align with the new regulations.
Thailand ????
The announcement details the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. The purpose of this new draft is to regulate medical device advertisements, promoting messaging that is truthful, ethical, and culturally appropriate. Find out what this means for your business and how to comply. ?
Starting in 2024, Thailand will implement a revised fee structure for medical device monitoring, auditing, and surveillance. This adjustment supports improved oversight and compliance. Explore what this means for the medical device industry.
Philippines?????
This initiative streamlines the application process, improving efficiency and compliance for medical device manufacturers and distributors. Learn more about the pilot results and its implications for CMDN applications nationwide. ?
The Philippines FDA has released Administrative Order No. 2024-0015, revising regulations for health product establishments. These updates aim to enhance compliance and safeguard public health. Discover the key updates and their implications for your business.
The Philippines FDA has released implementation guidelines for its updated schedule of fees and charges, impacting medical device and health product businesses. Find out what this means for your compliance obligations.
Vietnam ????
The Vietnam Ministry of Health has issued a comprehensive list of medical devices with HS codes, simplifying regulatory processes for businesses. Discover the implications for import and compliance. Discover the implications for import and compliance.
The Vietnam MOH has abolished rules on manufacturer codes and medical supplies encoding to streamline processes for medical device manufacturers and suppliers. Find out how this update affects your business.
The Vietnam Ministry of Health has issued guidance for medical device import licenses expiring by the end of 2024. Find out how to ensure continued compliance and uninterrupted operations.
The Vietnam Ministry of Health has drafted amendments to the Medical Device Management Decree, introducing changes to improve regulatory processes. Explore the potential implications for manufacturers and distributors.
Malaysia ????
Malaysia’s Medical Device Authority (MDA) has established new guidelines for handling obsolete and discontinued medical devices in healthcare facilities. These regulations emphasize safe management and disposal to maintain high safety standards. Find out what this means for medical device owners and operators.
Reach out to us! ??
Our expert in-house team is available for consultation in over 7 Southeast Asian countries!