Medical device distribution to Cambodia Home Only registered medical devices may be imported into Cambodia, which means the medical devices must be registered with the Department of Drug and Food (DDF) and have been issued with a Medical Device Registration License. Who can distribute medical devices in Cambodia? Only Cambodian companies who hold a valid …
Medical device distribution in Vietnam Home Only registered medical devices may be distributed in Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate also known as the Product …
Medical device distribution in Thailand Home Only registered medical devices may be distributed in Thailand, that means they must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health and been issued with a Product License (Listing Certificate/Notification Certificate/License). Importation depending upon their class, and unless exempted from …
Medical device distribution in Singapore Home Only registered medical devices may be distributed in Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR), unless exempted from registration (all Class A products). Who can distribute medical devices in Singapore? Only a company with a valid Wholesaler’s License (otherwise known as …
Medical device distribution in the Philippines Home Only registered medical devices may be imported into the Philippines, that means they must be registered with the Food and Drug Administration’s (FDA) Center for Device Regulation, Radiation, Health and Research (CDRRHR) and been issued with a Certificate of Medical Device Notification (CMDN), a Certificate of Medical Device …
Medical device distribution in Malaysia Home Only registered medical devices may be distributed in Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR), unless exempted from registration. Who can distribute medical devices in Malaysia? Only a company with a valid Distributor’s License may distribute medical devices in Malaysia. …
Medical device distribution in Indonesia Home Only registered medical devices may be distributed in Indonesia, which means that the product has been issued with a Distribution Approval Number or NIE (Nomor Izin Edar) otherwise known as the Product Approval License from the Ministry of Health via the Kemenkes Online Medical Device Registration platform unless exempted …
