Medical device importation to Cambodia
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 Corporate and Import-Pharmaceutical License from the Authority.
What are the requirements for importing medical devices into Cambodia?
- To import medical devices and IVDs, the company first must obtain a Certificate of Corporate as a business license and must register the company as an Import-Export Pharmaceutical Company at the Ministry of Health.
- The company also must hold a valid Medical device registration license.
- For shipment of importation, the company must apply for an import license from MOH first to process clearance at customs. In 2019, the Ministry of Health announced to participate using the Cambodia National Single Window (CNSW) portal launched by the Ministry of Economics to apply for an import license.
- Currently, only Cambodian companies can import and apply for an import license.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
Special Access Routes for importing medical devices into Indonesia
Special cases where special permits/certifications/exemptions are issued for unregistered medical devices:
- Emergency use such as during the COVID-19 pandemic
Importers' duties and obligations
It is mandatory for importers of medical devices and IVDs to Cambodia to:
- Maintain a record of all imports
- Keep all certificates of analysis of the devices
- Provide appropriate storage conditions to maintain the safety and quality of imported products
- Maintain valid product registration certificates
How Andaman Medical can help with importing medical devices to Cambodia:
Acting as your independent local authorized representative or marketing authorization holder in Cambodia, we will work with your license importers to:
- Authorize your selected importers to import your devices into Cambodia.
- Ensure that your license maintains post-marketing surveillance of your registered product.
- Liaise with your license importer concerning the mandatory reporting of Adverse Events and Product Calling.
We also offer additional support services such as:
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.