Medical device distribution to Cambodia
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 Certificate of Corporate and Import-Export Pharmaceutical company license may distribute in Cambodia.
- What is important to remember is that multiple importers and distributors may be appointed in Cambodia as long as the agreement between the manufacturer and the distributor is non-exclusive. This means you can have several distribution channels available to you at any one time.
- The advantage in Cambodia, the distributor or importer doesn't need to be a license holder. The foreign manufacturers can be license holder, but the registration dossier must be submitted by a local licensed importer that employs a Cambodian pharmacist. . However, the best way to be hassle-free is to appoint a third-party agent to act as LAR so you can switch distributor networks without affecting the product license.
What are the requirements for distributing medical devices in Cambodia?
- To distribute medical devices, the company must have a Certificate of Corporate for business and an Import-Export Pharmaceutical license.
- A valid product registration license is also mandatory.
Advertising rules
Advertising, communication, and promotion of medical devices are a common part of a distributor contract. Please note that any advertising activities must be applied for an advertisement license from the Department of Drugs and Food (DDF). The fee and validity depend on the advertising materials and activities.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in Cambodia to:
- Maintain a record of all imports and exports
- Maintain a valid product registration license
- Maintain records of any complaints
- Report any Adverse Events (AE) or Field Safety Corrective Actions (FSCA) to the Department of Drug and Food (DDF) as well as to the Local Authorized Representative
- Comply with Good Distribution Practice regulation.
