2024

Medical Device Post Market Surveillance (PMS) in Singapore Medical Device PMS Management for HSACompliance and Regulatory Confidence – Singapore In Singapore, post-market surveillance obligations must be carried out in accordance with Health Sciences Authority (HSA) regulations and national compliance requirements. Once a device is registered and placed on the market, manufacturers and their appointed local […]

Medical Device Post-Market Surveillance Post-Market Surveillance in Southeast Asia Placing a device on the market in Southeast Asia carries ongoing regulatory responsibility. Post-market surveillance (PMS) is a formal requirement for manufacturers and their appointed local dealers (economic operators), providing a framework to monitor safety, evaluate incidents, and maintain compliance throughout the product lifecycle. Indonesia, Malaysia,

Local Authorised Representative Local Authorised Representative Many countries require foreign manufacturers to have a Local Authorised Representative (LAR) in Southeast Asia if they don’t set up a foreign subsidiary. Also called an in-country representative, local agent, or marketing authorization holder, the LAR is the regulatory contact for medical devices or IVDs.  At Andaman Medical, we

Local Authorised Representative in Thailand Local Authorised Representative in Thailand Entering Thailand’s medical device market can be complex, especially when managing local regulations from abroad. That’s where Andaman Medical comes in. As a trusted Local Authorised Representative (LAR) in Thailand, we offer the regulatory expertise and in-country support you need for smooth market entry and

Medical Device Registration in Southeast Asia Streamlined Market Entry Across ASEAN Planning your medical device registration in Southeast Asia? The region offers significant growth opportunities through access to multiple high-growth healthcare markets, but navigating multiple regulatory systems can be complex. Although Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam are signatories to the ASEAN Medical

Stay Ahead with Medical Device Regulatory Insights Our in-house team of regulatory affairs specialists and market access experts are strategically located across our offices in seven major Southeast Asian markets. With daily engagement with local medical device regulatory authorities and government departments, we provide real-time updates and expert guidance on medical device registration, importation procedures,

Andaman Medical has been turning regulatory challenges into market opportunities throughout Southeast Asia since 2013. Our comprehensive solutions ensure smooth market access for medical device and IVD companies globally. With eight strategic offices across Southeast Asia and additional coverage in East Asia through Nord Pacific Medical, we provide comprehensive regional support for Medical Device &

Event & Other News Search Find Events Events Past Events Updates April 2026 View details View details View details May 2026 View details View details View details June 2026 View details View details View details July 2026 View details View details View details View details View details August 2026 View details View details View details

Event & Other News Search Find Events Events Updates March 2025 View details April 2025 View details View details Andaman Medical Indonesia Celebrates Independence Day with Enthusiasm and Team Spirit August 27, 2024 Last week, Andaman Medical’s Indonesian team came together to celebrate a significant milestone in the nation’s history—Indonesia’s Independence Day. The 17th of

Regulatory affairs and market access for medical devices & IVDs across Southeast Asia since 2013 Welcome to Andaman Medical. We are your trusted partner for regulatory affairs and market access in Southeast Asia. Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape

Sign Up To Our Newsletter! Get expert guidance on navigating Southeast Asia’s medical device markets! With 8 local offices and a team of experienced regulatory specialists, we provide the latest insights and updates for Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore and Cambodia. Don’t miss out—stay informed and ahead of the curve! Stay Ahead in Southeast

Medical Device Post-Market Surveillance in Southeast Asia Manufacturers and their locally appointed dealers (aka economic operators) are required to carry out Post-Market Surveillance (PMS) of their medical devices in the ASEAN market to ensure the quality and evaluate the safety, performance, and effectiveness of medical devices. This means manufacturers and appointed dealers shall actively monitor

Medical Device Registration All medical devices, whether manufactured domestically or imported, must be registered with local regulatory authorities before they can be placed on the market, with some exceptions and exemptions. Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam are signatories to the ASEAN Medical Device Directive (AMDD), harmonizing medical device registration in Southeast Asia.

Local Authorised Representative Many countries require foreign manufacturers to have a Local Authorised Representative (LAR) in Southeast Asia if they don’t set up a foreign subsidiary. Also called an in-country representative, local agent, or marketing authorization holder, the LAR is the regulatory contact for medical devices or IVDs. They handle all interactions with local medical

Medical Device Post-Market Surveillance (PMS) in Vietnam Keeping your medical devices safe, compliant, and reliable in Vietnam’s regulatory landscape can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Vietnam, we take the stress off your shoulders by managing the entire process for you. From navigating local regulations to demonstrating ongoing device performance

Medical Device Post-Market Surveillance in Thailand Maintaining compliance, safety, and reliability for your medical devices in Thailand can be complex. That’s where Andaman Medical steps in. With our expert post-market surveillance services in Thailand, we manage the entire process—from meeting Thai FDA requirements to tracking ongoing product performance and safety. We help ensure your devices

Medical Device Post Market Surveillance (PMS) in Singapore Medical Devices Post-Market Surveillance in Singapore Ensuring your medical devices remain safe, compliant, and effective within Singapore’s regulatory environment can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Singapore, we manage the entire process on your behalf. From meeting local requirements to monitoring ongoing

Medical Device Post-Market Surveillance (PMS) in the Philippines Ensuring your medical devices remain safe, compliant, and effective within the Philippines’ regulatory environment can be complex. With Andaman Medical’s expert medical device post-market surveillance in the Philippines, we take the burden off your shoulders by managing the entire process for you. From navigating local requirements to

Post Market Surveillance of Medical Devices in Malaysia The Medical Devices (Duties and Obligations of Establishment) Regulations 2019 detail the requirements for post market surveillance and vigilance for all medical devices in Malaysia as legislated for in Chapter 3 of the Medical Devices Act 2012 (Act 737). These regulations are imposed to ensure manufacturers, importers,