Medical Device Compliance Consultancy in Southeast Asia Medical devices are integral to modern healthcare, providing vital solutions that enhance patient care and save lives. As the medical landscape evolves in Southeast Asia, understanding and adhering to the complex regulatory requirements is critical for manufacturers eager to bring their innovations to market. Here is where Andaman […]
Medical Device Registration in Thailand Thailand’s dynamic healthcare market is full of opportunity, but its regulatory landscape can be challenging to navigate. That’s where Andaman Medical comes in. We simplify medical device registration in Thailand, guiding you through every step to ensure compliance with Thai FDA regulations and a faster market entry. Whether you’re a
How to register medical devices in Cambodia All medical devices, whether manufactured domestically in Cambodia or imported, must be registered with the Department of Drug and Food (DDF) under the Ministry of Health. Contact Us Home Who can register a medical device in Cambodia? To be able to register medical devices and in vitro diagnostic
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 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 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 Thailand All medical devices, whether manufactured domestically in Thailand or imported, must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Medical device registrations in Thailand must be submitted via the online medical device registration system called the “E-submission system”. Contact Us Home
Medical device registration in Indonesia Navigating Indonesia’s regulatory landscape for medical device post-market surveillance can be complex. With Andaman Medical’s expert MDR solutions, we take the burden off your shoulders by managing the entire process for you. From complying with local regulations to monitoring device performance and safety, we ensure your products remain compliant, reliable,
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, except for Class A low-risk medical devices, which are exempted from product registration. All product registration transactions including any future renewals or change notifications are conducted
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
