IVD Medical Device Registration 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?
Market Access
Market Access
Registering your IVD device grants you legal access to the Cambodian market. Without proper registration, you cannot legally sell or distribute your products within the country.
Regulatory Compliance
Regulatory Compliance
Compliance with Cambodian regulations ensures that your IVD device meets the safety, efficacy, and quality standards required by the Ministry of Health. This compliance not only avoids legal issues but also builds trust with healthcare providers and patients.
Brand Reputation
Brand Reputation
A registered IVD device enhances your brand’s reputation. It shows that you prioritize regulatory compliance and patient safety, which can lead to increased trust and loyalty from healthcare professionals and patients.
Facilitates Import and Export
Facilitates Import and Export
Registered devices can be imported and exported more smoothly, as they meet the regulatory requirements of Cambodia. This can streamline your supply chain and reduce delays in getting your products to market.
Legal Protection
Legal Protection
Proper registration provides legal protection for your product. It helps in defending against counterfeit products and ensures that your intellectual property rights are safeguarded.
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
The registration fee and timeline apply the same to all classes of medical devices and IVD.
| Class | Fee | Timeline |
|---|---|---|
| Class A, B, C, D | 400,000 KHR (100 USD) | 12 - 18 months |
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia
