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Phnom Penh, Cambodia

Cambodia

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 […]

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Phnom Penh, Cambodia

Cambodia

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

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Phnom Penh, Cambodia

Cambodia

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

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Cambodia countries we cover

Cambodia

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

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Regulatory services medical devices vietnam

Vietnam

Medical device registration in Vietnam All medical devices, whether manufactured domestically in Vietnam or imported, must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health.  Contact Us Home Who can register a medical device in Vietnam? Only companies registered locally in Vietnam and who have a valid

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Regulatory services medical devices philippines

Philippines

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

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Andaman Medical Thailand

Thailand

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

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Regulatory Services Medical Devices Singapore BW

Singapore

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

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Regulatory services medical devices malaysia

Malaysia

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

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Andaman Medical Indonesia

Indonesia

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

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Regulatory services medical devices vietnam

Vietnam

Post Market Surveillance of Medical Devices in Vietnam The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post-market surveillance (PMS) 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

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Regulatory services medical devices philippines

Philippines

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

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Andaman Medical Thailand

Thailand

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)

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Regulatory Services Medical Devices Singapore BW

Singapore

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

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Regulatory services medical devices malaysia

Malaysia

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,

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Andaman Medical Indonesia

Indonesia

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

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Regulatory services medical devices malaysia

Malaysia

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.

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Regulatory Services Medical Devices Singapore BW

Singapore

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

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Andaman Medical Thailand

Thailand

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

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Regulatory services medical devices philippines

Philippines

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

Philippines Read More »

Regulatory services medical devices vietnam

Vietnam

Local authorised representative in Vietnam The Ministry of Health in Vietnam 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 in Vietnam since 2017. Contact Us

Vietnam Read More »

Andaman Medical Indonesia

Indonesia

Local authorised representative in Indonesia The Ministry of Health in Indonesia 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 in Indonesia since 2016. Contact Us

Indonesia Read More »

Regulatory services medical devices vietnam

Vietnam

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

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Regulatory services medical devices philippines

Philippines

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

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Andaman Medical Thailand

Thailand

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

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Andaman Medical Indonesia

Indonesia

Medical device registration in Indonesia All medical devices, whether manufactured domestically in Indonesia or imported, must be registered with the Ministry of Health via the Online Medical Device Registration platform (hereafter called the Kemenkes system). Contact Us Home Who can register a medical device in Indonesia? In order to register a medical device in Indonesia,

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Regulatory Services Medical Devices Singapore BW

Singapore

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

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