Local authorised representative in Cambodia
The Department of Drug and Food (DDF) which is under the Ministry of Health (MOH) requires foreign manufacturers who have not set up their legal subsidiary to appoint a Local Authorized Representative (LAR), sometimes referred to as the in-country representative for product registration on behalf of the foreign manufacturers.
What are the (legal) requirements for a LAR in Cambodia?
The in-country representative must be a local licensed pharmaceutical company which has a Cambodian pharmacist name as the representative.
Can you appoint multiple marketing authorization holders or registrants in Cambodia?
- No, in Cambodia, one device is allowed to register by only one registrant per time.
- Foreign manufacturers need to issue a letter of authorization (LOA) to appoint /authorize the registrant to register their product.
- The registrant can be changed during renewal.
- The foreign manufacturers can be a license holder, but the registration dossier must be submitted by a local licensed importer that employs a Cambodian pharmacist. The foreign manufacturer can appoint either themselves or their local distributor as the license holder /marketing authorization holder.
How Andaman Medical can help with in-country representation in Cambodia:
As your in-country representative/ license holder/ registrant in Cambodia we will:
Represent your company in all dealings with the DDF and other authorities responsible for medical devices and in-vitro diagnostics including:
- Registering your product
- Dealing with all regulatory issues
- Submitting change notification
- Reporting Adverse Events
- Ensure that the medical device or IVD is correctly labeled, and that information is provided in English
- Maintain communication with the appointed distributor
- Accept all calls from the FDA regarding the foreign manufacturer and its products and liaise accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
- Obtaining advertisement permit if there are any advertising events/ activities.
