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 …
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 …
How to register medical devices with the FDA Philippines Home 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 …
Medical device registration in Malaysia Home Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737). All medical devices that are imported, exported or placed on the market in Malaysia …
Medical device registration in Thailand Home 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”. Who can …
Medical device registration in Indonesia Home 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). Who can register a medical device in Indonesia? In order to register a medical device in Indonesia, a company …
Medical device registration in Singapore Home 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 …
