Medical Device Registration in Cambodia

Your Market Entry into an Emerging Healthcare Market - Cambodia

Cambodia’s growing healthcare sector presents exciting opportunities for medical device manufacturers. However, navigating the country’s regulatory framework can be challenging without the right local expertise.

At Andaman Medical, we manage the full medical device registration process in Cambodia from start to finish. From interpreting local regulations to ensuring complete regulatory compliance, we guide you through every step so your products can reach the market efficiently. Whether you are an emerging manufacturer or an established global company, we handle the regulatory complexity so you can stay focused on delivering safe, high-quality medical technologies.

Why Register Your IVDs or Medical Devices in Cambodia?

  • Enter an emerging healthcare market with increasing demand for reliable medical technologies
  • Strengthen your Southeast Asia market entry strategy through early positioning in a developing market
  • Navigate Cambodia’s evolving regulatory framework with expert local guidance
  • Maintain long-term regulatory compliance and continuous product availability

Partner with Andaman Medical for seamless medical device registration in Cambodia. We manage the regulatory process so you can focus on delivering high-quality healthcare solutions.

Market Access

Market Access

Registering your medical 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 medical 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 medical 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.

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.

Who Can Register a Medical Device in the Cambodia?

To register medical devices and in vitro diagnostics (IVDs) in Cambodia, a company must first obtain a Certificate of Corporate from the Ministry of Commerce (MoC) and then legally register with the Ministry of Health (MoH). To obtain a local pharmaceutical company licence, the company must appoint a Cambodian pharmacist as their representative.

Options for Foreign Manufacturers

1

Set Up a Legal Subsidiary Entity

  • Obtain a Certificate of Corporate from the MoC.
  • Obtain a pharmaceutical company licence from the MoH.
  • Set up a local office and appoint a local pharmacist representative.

2

Appoint a Local Distributor

The distributor must have a valid Certificate of Corporate and a pharmaceutical company licence to register the medical devices.

3

Appoint an Independent Third Party

  • Use a company like Andaman Medical, which has a valid Certificate of Corporate and pharmaceutical company licence.
  • Andaman Medical can act as a local authorised representative and register all classes of medical devices (A, B, C, and D) on behalf of foreign manufacturers.
  • They handle all regulatory issues and maintain your licence, allowing you to appoint any importer or distributor without affecting your product licence if the distributorship changes.

Classification of Medical Devices in Cambodia

In Cambodia, medical devices are classified based on risk, following the ASEAN Medical Device Directive (AMDD):

  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk
  • Class D: High Risk
The risk classification depends on the intended purpose of the device and the effectiveness of risk management during its design, manufacture, and use. The Department of Drug and Food (DDF) classifies the device according to the manufacturer’s stated classification in the dossier.

Medical Device Grouping in Cambodia

Currently, there is no “product grouping” available in Cambodia. Each specific medical device must be registered separately.

Registration Process Overview

Submission

Registration applications for all classes of medical devices and IVDs are manually submitted to the Drug Registration Bureau in the DDF. The dossier must be submitted in both soft copy (USB flash drive) and hard copy (application form and required documents).

Pre-assessment

The dossier is pre-assessed by an authority officer. If the documents comply with the checklist, payment is requested.

Payment

Once payment is made, the application details and device data are recorded in the Drug Registration Bureau's internal system.

Evaluation

The evaluation process involves several ranks of officers and concludes at the Secretary of State (MoH) office. Final approval is conducted quarterly, although delays are common.

Required Documents for Registration

  • Executive Summary
  • Relevant Essential Principles and Methods Used to Demonstrate Conformity
  • Device Description
  • Summary of Design Verification and Validation Documents
  • Device Labelling
  • Risk Analysis
  • Manufacturer Information
  • 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 are the same for all classes of medical devices and IVDs.

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

Navigating medical device registration in Cambodia can be complex, but Andaman Medical is here to simplify the process and ensure you stay fully compliant. Connect with our experts today and take the first step toward smooth registration!

Learn more about Medical Device Registration in Cambodia
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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.
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