Countries

Phnom Penh, Cambodia

Cambodia

Local authorised representative in Cambodia Home 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. …

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Phnom Penh, Cambodia

Cambodia

Cambodia’s Medical Device Market 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 not available. …

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Phnom Penh, Cambodia

Cambodia

Post Market Surveillance of Medical Devices in Cambodia Home 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.   What are the requirements for …

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Cambodia countries we cover

Cambodia

How to register medical devices in Cambodia Home 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. Who can register a medical device in Cambodia? To be able to register medical devices and in vitro diagnostic (IVD) in …

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Regulatory services medical devices vietnam

Vietnam

Medical device registration in Vietnam Home 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.  Who can register a medical device in Vietnam? Only companies registered locally in Vietnam and who have a valid Establishment License …

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Regulatory services medical devices philippines

Philippines

The Philippines’ Medical Device Market 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 medical devices …

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Andaman Medical Thailand

Thailand

Thailand’s Medical Device Market 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 Solutions reports. …

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Regulatory Services Medical Devices Singapore BW

Singapore

Singapore’s Medical Device Market 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 in July …

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Regulatory services medical devices malaysia

Malaysia

Malaysia’s Medical Device Market 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 reports. Malaysia …

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Andaman Medical Indonesia

Indonesia

Indonesia’s Medical Device Market 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 measures to …

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