IVD Medical Device Registration in Cambodia

Cambodia is a burgeoning market for medical device manufacturers seeking to expand in Southeast Asia. The Ministry of Health (MoH) regulates the registration and approval of medical devices in Cambodia.

Our team of experienced regulatory affairs specialists can assist you in navigating the MoH registration process for your medical devices. We offer comprehensive support, from initial classification and submission to post-market compliance.

Why Register Your IVD Medical Device in Cambodia?

Registering your IVD device in Cambodia gives you a significant advantage for several reasons:

Our IVD Medical Device Registration Services

Regulatory Strategy

Customised regulatory strategy tailored to your device's classification and target market.

Dossier Preparation

Compiling and reviewing all necessary documentation for Ministry of Health (MoH) requirements.

Submission Management

Managing the entire submission process, including communication with the MoH.

Post-Market Compliance

Support in adverse event reporting, change notifications and more.

HSA Registration Process Overview

Registering your IVD medical device in Cambodia  involves the following well-defined steps by the Ministry of Health (MoH). These processes are designed to assess and validate the safety and efficacy of medical devices: 

Step 1: Classification

Medical devices are classified based on their intended use and potential risks as below: 
Class A: Low risk devices 
Class B: Low to moderate risk devices 
Class C: Moderate to high risk devices 
Class D: High risk devices

Step 2: Submission

The registration dossier is submitted to the MoH, which includes documents such as: 

  • 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 Authorisation

Step 3: Evaluation

MoH reviews the submission and may request additional information or clarification. It will then be evaluated by multiple ranks of officers at the Secretary of State (MOH) office. The final approval is conducted every 3 months, but anticipate any delays during this process.

Step 4: Approval

After successful evaluation, MoH issues a registration certificate valid for three years, after which a new application must be submitted for renewal.

Step 1: Classification

Medical devices are classified based on their intended use and potential risks as below: 
Class A: Low risk devices 
Class B: Low to moderate risk devices 
Class C: Moderate to high risk devices 
Class D: High risk devices

Step 2: Submission

The registration dossier is submitted to the MoH, which includes documents such as: 

  • 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 Authorisation

Step 3: Evaluation

MoH reviews the submission and may request additional information or clarification. It will then be evaluated by multiple ranks of officers at the Secretary of State (MOH) office. The final approval is conducted every 3 months, but anticipate any delays during this process.

Step 4: Approval

After successful evaluation, MoH issues a registration certificate valid for three years, after which a new application must be submitted for renewal.

Typical Fees and Timeline

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

Why Choose Andaman Medical as Your IVD Consultant in Cambodia?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for IVD registration and market access in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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