Medical device importation to Cambodia Home Only registered medical devices may be imported into Cambodia, which means they must be registered with the Department of Drug and Food (DDF) and be issued with a Medical Device Registration License. Any Company wishing to import medical devices and in-vitro diagnostic (IVDs) must have a valid Certificate of …
Medical device importation to Vietnam Home Only registered medical devices may be imported into 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 unless exempted from registration (see …
Medical device importation to Thailand Home Only registered medical devices may be imported into Thailand, that means they must be registered with the Thai Food and Drug Administration and has been issued with a Listing Certificate, Notification Certificate or License prior to importation unless exempted from registration (see below). What are the requirements for importing …
Medical device importation to Singapore Home Only registered medical devices may be imported into Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR) unless exempted from registration (all Class A products). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Singapore must have a valid Importer’s …
Medical device importation to 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 importation to Malaysia Home Only registered medical devices may be imported into Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR) unless exempted from registration (see below). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Malaysia must have a valid Establishment Licence …
Medical device importation to Indonesia Home Only registered medical devices may be imported into Indonesia, which means only products that have 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 Online Medical Device Registration platform (hereafter called the …
