Medical Device Product Registration and Approval in Cambodia
MEDICAL DEVICE REGULATION IN CAMBODIA
Medical devices are regulated by the Department of Drugs and Food (DDF) in the Ministry of Health in Cambodia whose objective is to ensure the quality and safety of medical devices that are locally produced or imported from other countries. They follow regulations that are in line with the ASEAN Medical Device Directive (AMDD).
MEDICAL DEVICE REGISTRATION AND APPROVAL IN CAMBODIA
Recently, DFF clarified that the License Holder and Manufacturer can be a foreign company. But the registration dossier must be submitted by a local licensed pharmaceutical importer that employs a Cambodian pharmacist.
The local pharmaceutical importer can prepare, sign and submit the application dossier, liaise with the DDF on the dossier, and receive the product registration certificate, all on behalf of the foreign manufacturer.
Medical devices are classified into 4 categories namely class A, B, C and D (A being the lowest risk and D being the highest risk).
If the classification has not yet taken place in any ASEAN jurisdiction, we would need to classify the product first by visiting the DDF. Lastly, please note family registration for medical devices is not available in Cambodia.
Registration timeline usually takes six to twelve months, but delays are common. Sometimes authorities exercise their discretion during registration and delay procedures in an effort to solicit unofficial payments. Since we are bound by our firm’s zero-tolerance anti-corruption policy, we are strictly prohibited from making any unofficial payments to expedite action from the authorities.