Cambodia recognises Drug-Device Combination Status in Singapore, Malaysia and Indonesia
December 17, 2018
As of present, there are a total of 1,985 medical devices and 1,136 reagents registered.
Currently in Cambodia, the AMDD is already translated into the national language and has been approved by the MOH. This means that the current registration guideline has already been updated to be in harmonization with the AMDD. The ratification to the AMDD is still ongoing and is expected to be completed by 2019.
For drug-device combinations, reference approvals from Singapore, Malaysia and Indonesia will be considered if they are classified as a drug or a device in Cambodia.
The validity of registration license is 3 years and renewal submission must be 6 months before the expiration date of the existing license.
Requirements for Labeling:
Name of product;
Name and Address of Manufacturer;
Name and Address of Marketing Holder/ Product Owner;
Batch number, Manufacturing date and expiration date (for consumable devices, disinfectants and reagents);
Storage condition (for disinfectants and reagents); and
Instructions for use, precaution, restriction and other necessary information.