2024

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

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 Compliance Consultancy Andaman Medical’s Medical Device (MD) Compliance Consultancy offers expert guidance through the complex regulations in Southeast Asia, covering markets including Singapore, Malaysia, Indonesia, the Philippines, Thailand, Vietnam, and Cambodia. Our team of experts ensures that your medical devices meet all necessary requirements for market entry and ongoing compliance. With a deep

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 The Thai Food and Drug Administration (Thai FDA) as a department of the Ministry of Public Health requires the Establishment License Holder, the Product License Holder or the Specification Provider to report medical device problems including device defects or Adverse Effect (commonly known as Adverse Events AE) and Field

Medical Devices Post-Market Surveillance in Singapore The Health Science Authority (HSA) in Singapore requires product owners to implement a Post Market Surveillance (PMS) plan in place in accordance with the ASEAN Medical Device Directive (AMDD) in 2015. However, each ASEAN member state is free in implementing the PMS for medical device requirements and each country

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,

Medical Devices Post-Market Surveillance in Cambodia The Department of Drug and Food requires foreign manufacturers to undertake Cambodia’s post-market surveillance (PMS) of medical devices, following the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read further to understand how post-market surveillance of medical devices is implemented in Cambodia. Contact

Local Authorised Representative in Vietnam Entering Vietnam’s medical device market can be challenging, especially when navigating local regulations from overseas. That’s where Andaman Medical comes in. As a trusted Local Authorised Representative (LAR) in Vietnam since 2017, we provide the local expertise and regulatory support you need to achieve smooth market access and ongoing compliance.

Local Authorised Representative in Thailand The Food and Drug Administration (FDA) or medical device authority in Thailand requires foreign manufacturers without a legal subsidiary to appoint a Local Authorised Representative (LAR), also known as an in-country representative or marketing authorization holder. Andaman Medical has been serving as a Local Authorised Representative in Thailand since 2017.

Local Authorised Representative in Singapore The Health Sciences Authority (HSA) in Singapore requires foreign manufacturers without a legal subsidiary to appoint a Local Authorised Representative (LAR), also known as an in-country representative, local marketing authorization holder, or Registrant. Andaman Medical has been serving as a Local Authorised Representative in Singapore since 2015. Contact Us Why

Local Authorised Representative in the Philippines Entering the Philippines’ medical device market can be challenging, especially when managing local regulations from abroad. That’s where Andaman Medical comes in. As a trusted Local Authorised Representative (LAR) in the Philippines, we offer the local knowledge and regulatory support you need to secure smooth market entry and maintain

Local authorized representative in Malaysia The Medical Device Authority (MDA) in Malaysia requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorized Representative (LAR). The LAR is also called an in-country representative or marketing authorization holder. Andaman Medical has been a Local Authorized Representative in Malaysia since 2014.

Local authorised representative in Cambodia The Department of Drug and Food (DDF) which is under the Ministry of Health (MOH) requires foreign manufacturers who have not set up their legal subsidiary to appoint a Local Authorised Representative in Cambodia. Find out how you can get in-country representation for your medical products with Andaman Medical. Contact

Medical Device Registration in the Philippines The Philippines’ healthcare market is rapidly growing, offering significant opportunities for medical device companies—but navigating its regulatory framework can be challenging and time-intensive. That’s where Andaman Medical steps in. With our proven expertise in medical device registration in the Philippines, we simplify the process and provide clear guidance every

Medical Device Registration in Singapore All medical devices, whether manufactured domestically or imported, must be registered with the Health Science Authority (HSA) before they can be supplied in Singapore. However, Class A low-risk medical devices are exempt from product registration. All product registration transactions, including renewals or change notifications, are conducted online through the Medical

Medical Device Registration in Cambodia Cambodia is an emerging market for medical device manufacturers looking to expand their presence in Southeast Asia. The Ministry of Health (MoH) oversees the regulation, registration, and approval of medical devices in the country. All medical devices, whether manufactured domestically in Cambodia or imported, must be registered with the Department

Medical device registration in Malaysia Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737). All medical devices that are imported, exported or placed on the market in Malaysia whether

Medical Device Registration in Vietnam Vietnam’s dynamic healthcare sector is full of potential—but navigating its regulatory landscape can be complex and time-consuming. That’s where Andaman Medical comes in. With our trusted expertise in medical device registration in Vietnam, we make the process clearer and more manageable. From understanding local requirements to ensuring full compliance, we

Medical Device Registration in Thailand Thailand is a rapidly growing market for medical devices, driven by its expanding healthcare sector and increasing demand for state-of-the-art medical technologies. For international manufacturers, understanding the medical device registration process in Thailand will go a long way in entering this promising market. All medical devices, whether manufactured domestically or