October Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices in Southeast Asia
Hey there,
The regulatory world is buzzing this November, and we want to ensure you're staying on top of the latest updates. We’ve rounded up the latest changes across Southeast Asia, so grab your coffee and dive into the updates that matter most for your medical devices and diagnostics.
Did we mention, we also have a sneak peek at upcoming events that could make a big impact on your business? It’s the best of both worlds. Read on to find out what’s new and what’s next!
Key Highlights ✨
🌐 Webinar: EU MDR & IVDR - How this affects the Southeast Asia market (25 Nov 2024)
How will the EU MDR & IVDR updates impact medical device and IVD companies in Southeast Asia? Find out on Monday, November 25, 2024, from 3:00 PM to 4:30 PM SGT in our upcoming webinar. Our experts will guide you through the new compliance challenges these updates bring and provide actionable advice to stay ahead. Save the date and join us!
📅 Event: Healthcare Expo Taiwan (5-8 Dec 2024)
We’re excited to participate in the Healthcare Expo Taiwan, at Taipei Nangang Exhibition Center! Come by Booth N1029 to connect with our team and explore how Andaman Medical can support your entry into Southeast Asia. We look forward to seeing you there!
🎤Online Seminar: OMETA Healthcare (10 Dec 2024)
Andaman Medical is excited to be part of the OMETA Healthcare Seminar on December 10, 2024, hosted by Nord Pacific Medical. This seminar promises valuable discussions on emerging healthcare trends and compliance challenges. Sign up now to gain insights from our experts and discover solutions for your regulatory needs across Southeast Asia.
🗣 Southeast Asia Medical Device Market Entry Seminar and Panel Discussion (12 Dec 2024)
Andaman Medical and Nord Pacific Medical are excited to invite you to a seminar and expert panel discussion, designed to guide medical device companies through the complexities of Southeast Asian market entry. Don’t miss this opportunity. Email dai@nordpacificmed.com to book your seat today!
Regulatory Update 📝
Indonesia 🇮🇩
Indonesia's Ministry of Communication and Information has introduced a regulation that outlines the requirements for overseas testing centers involved in the certification of telecommunication devices and equipment. Discover how this affects manufacturers and their certification processes.
Thailand 🇹🇭
The Thai Food and Drug Administration (FDA) has implemented guidelines for using previously submitted documents in new medical device applications, easing the process for manufacturers and importers. Understand the specific cases and procedures under which document referencing can streamline regulatory submissions.
Thailand's Ministry of Public Health has rolled out new standards under Notification No. 4 B.E. 2567 (2024) that local medical device manufacturers and importers must now comply with. Find out what’s required under the latest regulatory framework and its impact on the medical device industry.
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A new notification from Thailand’s Ministry of Public Health restricts certain medical device sales exclusively to healthcare providers and public health professionals. Read on to understand the regulatory requirements and compliance steps for operating in Thailand.
The Thailand Ministry of Public Health has issued Notification No. 3 B.E. 2567 (2024), requiring that all medical devices display shelf life, warnings, and precautions on their labels or in instructions for use. Find out what this means for your business and how to comply.
This visual guide aims to simplify the process for manufacturers and distributors, helping them stay compliant with regulatory requirements in Thailand. Learn more about how this infographic can assist your business.
This guidance is essential for companies looking to market wound care products in Thailand. Learn more about how this affects wound dressing product registration in Thailand.
The Thai FDA has introduced a new format for the consent form used in the Reliance Program, designed to streamline the submission process for medical device approvals. Learn more about the changes and what they mean for your submissions.
The Thai FDA has released an infographic explaining the process for referring and transferring approved licenses, aimed at clarifying steps for license holders and applicants. Learn more about the new guidelines.
This update outlines labeling requirements that manufacturers and distributors need to follow for medical devices in Thailand. Read more to understand how these guidelines affect your labeling processes in Thailand.
Singapore 🇸🇬
Singapore’s Health Sciences Authority has introduced Good Submission Practice guidelines to support medical device manufacturers in submitting clear, comprehensive applications. Read more about the compliance steps needed to meet these new standards.
Vietnam 🇻🇳
Vietnam’s Ministry of Health has announced new procedures for managing import applications of medical devices submitted before 2022 but still pending approval. This guidance is essential for manufacturers to understand their options and compliance obligations. Find out more about the impact on your business in Vietnam.
Vietnam is gathering feedback on its draft Medical Device Law to create a comprehensive regulatory framework that supports innovation and compliance. Stakeholders in the medical device industry are invited to participate in this survey to influence future regulations. Find out more about the survey process.
Reach out to us! 📨
Our expert in-house team is available for consultation in over 7 Southeast Asian countries!