2024

Regional Expertise and Dynamic Teams At Andaman Medical, our strength lies in the depth of expertise of our regional teams. By embracing local knowledge, we bring impactful solutions to clients across Southeast Asia. Our teams are strategically located across the region, offering a deep understanding of the local regulatory landscapes, cultural nuances, and market dynamics. […]

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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 in Vietnam The Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MoH) requires foreign manufacturers to conduct post-market surveillance (PMS) of medical devices in Vietnam, in line with the ASEAN Medical Device Directive (AMDD), which took effect on 1st January 2015. However, each ASEAN member state has

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 Devices Post-Market Surveillance in the Philippines The Philippines’ Food and Drug Administration (PFDA) is the local authority responsible for the medical devices in the Philippines and requires all medical device manufacturers and distributors (whether importer, exporter or wholesaler) to undertake post-market surveillance (PMS) and have a PMS plan. The Philippines FDA has chosen to

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

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 In compliance with the Ministry of Health regulations, foreign manufacturers without a legal subsidiary in Vietnam must appoint a Local Authorised Representative (LAR), also known as an in-country representative or marketing authorisation holder. Andaman Medical has served as a Local Authorised Representative in Vietnam since 2017. Contact Us Why Appoint

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 The Food and Drug Administration (FDA) or medical device authority in the Philippines requires foreign manufacturers without a legal subsidiary to appoint a Local Authorised Representative (LAR), also known as an in-country representative or local agent. Andaman Medical has been serving as a trusted Local Authorised Representative in the

Local Authorised Representative in Malaysia Entering Malaysia’s medical device market can be a complex process, especially if you’re navigating it from abroad. That’s where Andaman Medical comes in. As a trusted Local Authorised Representative (LAR) in Malaysia since 2014, we provide the local expertise and hands-on support you need to ensure seamless market access and

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 Philippines All medical devices, whether made locally or imported, must be registered with the Philippines FDA’s Center for Device Regulation, Radiation, Health, and Research (CDRRHR). Class A devices are registered through the online “e-notification portal system”. Class B, C, D, and IVD devices are registered via email. Contact Us Why Register

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 Malaysia’s thriving healthcare market offers incredible opportunities, but navigating the regulatory process can feel overwhelming. That’s where Andaman Medical steps in. With our expert guidance in medical device registration in Malaysia, we simplify every step, helping you overcome challenges, avoid delays, and secure a smooth market entry. Whether you’re an

Medical Device Registration in Vietnam The In Vitro Diagnostics (IVD) market in Vietnam is growing rapidly, driven by demand for early disease detection and advancements in healthcare. The Department of Medical Equipment and Construction (DMEC) regulates IVD device registration to ensure safety and quality. Our medical device registration consultancy in Vietnam offers complete support, from

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

Medical Device Registration in Indonesia Indonesia is experiencing significant growth in the healthcare sector, driven by an increasing demand for medical devices. Understanding Indonesia’s regulatory requirements for medical device registration is essential for ensuring safe and effective access to healthcare devices in the market. All medical devices, whether domestically manufactured or imported, are required to

Local Authorised Representative in Indonesia The Indonesian Ministry of Health requires foreign manufacturers without a local subsidiary to appoint a Local Authorised Representative (LAR), also known as an in-country representative or market authorisation holder. Andaman Medical has been serving as a Local Authorised Representative in Indonesia since 2016. Contact Us Why Get Local Authorised Representative

Medical Device Post-Market Surveillance in Indonesia Post-market surveillance of medical devices in Indonesia is controlled by the Surveillance Directorate of Medical Device and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) in the Ministry of Health (MoH). Manufacturers and their local authorised representative or importer are required to implement post-market surveillance (PMS) in accordance with

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 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