How to register medical devices in Cambodia
All medical devices, whether manufactured domestically in Cambodia or imported, must be registered with the Department of Drug and Food (DDF) under the Ministry of Health.
Who can register a medical device in Cambodia?
To be able to register medical devices and in vitro diagnostic (IVD) in Cambodia, the company must first obtain their Certificate of Corporate from the Ministry of Commerce (MoC), then legally registered their company at the Ministry of health (MoH). To obtain the local pharmaceutical company license, the company must have a Cambodian pharmacist name to be their representative in the license.
For foreign manufacturers, there are 3 possibilities to register their medical devices and IVD in Cambodia:
Set up a legal subsidiary entity
To register the medical device, a Certificate of Corporate from (MOC) and pharmaceutical company license from (MOH) is required. A local office set up and having a local pharmacist representative is a must.
Appoint a local distributor
That has a valid Certificate of Corporate and Pharmaceutical company license to register the medical devices.
Appoint an independent third party
Such as Andaman Medical to register the medical device. Andaman Medical has a valid Certificate of Corporate and Pharmaceutical company license which can act directly as a local authorized representative and can register all classes of medical devices: A, B, C, and D on behalf of foreign manufacturers. We handle all regulatory issues, and maintaining your license, so you can appoint any importer or distributor without affecting your product license once the distributorship change.
Classification of medical devices in Cambodia
The medical device in Cambodia are classified in terms of risk following the ASEAN Medical Device Directive (AMDD), which lists 4 classes:
Class A, Low Risk
Class B, Low to Moderate Risk
Class C, Moderate to High Risk
Class D, High Risk
The risk presented by a medical device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during the design, manufacture, and use. Hence, the risk classification depends upon the design and claims made by the product owner and on its intended purpose.
The Department of Drug and Food (DDF) will follow the classification (A,B,C,D) of the device according to the manufacturer/ product owner stated in the dossier.
Medical device grouping in Cambodia
Currently, there is no “product grouping” available in Cambodia. An application must be made separately for each specific medical device.
The registration process
Registration application of all classes of medical devices and IVDs are manually submitted to the Drug Registration Bureau in DDF. The dossier shall be submitted in soft copy (USB flash drive) along with a hard copy application form and some required documents. The authority officer responsible for dossier evaluation will do the pre-assessment. Should all the submitted documents comply with the checklist, payment will be requested. After the payment is done, the application details and device data will be recorded in the Drug Registration Bureau internal system. Evaluation process will continue with many ranks of officers till completed at the Secretary of State (MOH) office. The final approval will be conducted every 3 months, however, delays on the schedule are common in Cambodia.
What documents are required to register medical devices in Cambodia?
Various documentation is required to register a medical device in Cambodia. Only Cambodian and English languages are accepted.
In general, you will be required to submit a Common Submission Dossier Template (CSDT):
a) Executive Summary
b) Relevant Essential Principles and Methods Used to Demonstrate Conformity
c) Device Description
d) Summary of Design Verification and Validation Documents
e) Device Labeling
f) Risk Analysis
g) Manufacturer Information
Documents that are mandatory to submit along are:
- Certificate of GMP or Certificate of ISO from the Country of Origin
- Certificate of Free Sale from the Country of Origin
- Certificate of Analysis from the Country of Origin
- Declaration of Conformity Letter
- Letter of Authorization
Typical fees and timelines
A fee is payable for each new medical device registration and renewal.
The registration fee and timeline apply the same to all classes of medical devices and IVD.
For medical device and IVD new and renewal registration:
| Class | Fee | Timeline |
|---|---|---|
| Class A, B, C, D | 400,000 KHR (100 USD) | 12 - 18 months |
How Andaman Medical can help:
Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists will register your medical device in Cambodia.
Our registration services include:
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Amendment and change notification
- Product license transfer
Our authorised representative services include:
- Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
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
- Relabelling