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 Authorized Representative (LAR), sometimes referred to as the in-country representative for product registration on behalf of the foreign manufacturers. Contact […]
Cambodia’s Medical Device Market Contact Us Home The medical device market in Cambodia Cambodia’s market for medical device imports is growing, doubling in size between 2015 and 2020 according to health professionals. The establishment of new private hospitals has boosted the demand for quality machinery. Cambodia depends heavily on imported devices since local production is
Post Market Surveillance of Medical Devices in Cambodia The Department of Drug and Food requires foreign manufacturers to undertake post-market surveillance (PMS) following the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read further to understand how post-market surveillance is implemented in Cambodia. Contact Us Home What are the
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
The Philippines’ Medical Device Market Contact Us Home The medical device market in the Philippines The medical device market in the Philippines is expected to see a compound annual growth rate (CAGR) of 8.8% growing to US$884.3 million by the end of 2024 as reported by Fitch Solutions. The Philippines relies heavily on imports for
Thailand’s Medical Device Market Contact Us Home The medical device market in Thailand The domestic medical device market in Thailand is forecasted to be worth US$2.0 billion in 2022, with a Compound Annual Growth Rate (CAGR) of 7.5% between 2018 and 2022F according to a report published by KPMG based on figures sourced from Fitch
Singapore’s Medical Device Market Contact Us Home The medical device market in Singapore Singapore’s domestic medical device market is projected to register a compound annual growth rate (CAGR) of 8.4 per cent between 2018 to 2023, with the industry valued at almost US$1 billion in 2023, according to a report by Fitch Solutions Macro Research
Malaysia’s Medical Device Market Contact Us Home The medical device market in Malaysia The domestic medical device market in Malaysia is forecasted to be worth US$2.0billion in 2022, with a Compound Annual Growth Rate (CAGR) of 7.5% between 2018 and 2022F according to a report published by KPMG based on figures sourced from Fitch Solutions
Indonesia’s Medical Device Market Contact Us Home The medical device market in Indonesia The domestic medical device market in Indonesia was forecasted to be worth US$3.0 billion by 2020, with a compound annual growth rate (CAGR) of 5.8% between 2017 and 2020 according to the Indonesian Medical Device Producers Association (ASPAKI) In spite of protectionist
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
Post-Market Surveillance of Medical Devices in the Philippines The Philippines’ Food and Drug Administration (PFDA) is the local authority responsible for 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
Post Market Surveillance of Medical Devices 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)
Post Market Surveillance of Medical Devices 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) which came into effect on 1st January 2015. However, each ASEAN member state is free in implementing the
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
Post Market Surveillance of Medical Devices in Indonesia Post market surveillance of medical devices in Indonesia is under the control of the Surveillance Directorate of Medical Device and Household Health Supplies (PKRT) in the Ministry of Health (MoH). Manufacturers and their local authorized representative or importer are required to implement post market surveillance (PMS) in
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 Singapore The Health Sciences Authority (HSA) or medical device authority in Singapore require foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative, local marketing authorization holder or Registrant. Andaman Medical has been a Registrant in
Local authorised representative in Thailand The Food and Drug Administration (FDA) or medical device authority in Thailand requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder. Andaman Medical has been a local authorized representative
Local authorised representative in the Philippines The Food and Drug Administration (FDA) or medical device authority in the Philippines requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorized Representative (LAR), sometimes referred to as the in-country representative or local agent. Andaman Medical has been a local authorized
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 Indonesia Expanding into Indonesia’s medical device market can be challenging without local expertise. That’s where Andaman Medical comes in. As a trusted Local Authorised Representative (LAR) in Indonesia, we provide the local expertise and regulatory support you need to ensure seamless market entry and compliance. From handling complex requirements to ensuring
Vietnam’s Medical Device Market Contact Us Home The medical device market in Vietnam The domestic medical device market in Vietnam is forecasted to be worth US$ 1.8 Billion by 2022, with a compound annual growth rate (CAGR) of 9.6% between 2017 and 2022F according to a report by Ken Research In terms of domestic consumption
How to register medical devices with the FDA Philippines All medical devices, whether manufactured domestically in the Philippines or imported, must be registered with the Philippines Food and Drug Administration’s (FDA) Center for Device Regulation, Radiation, Health and Research (CDRRHR). Registrations of Class A medical devices are currently being processed via an online medical device
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 PMS 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
ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653
ANDAMAN MEDICAL PTE LTD
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653
