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AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - CAMBODIA)

In Cambodia, the regulation of medical devices falls under the jurisdiction of the Department of Drugs and Food (DDF) within the Ministry of Health. The primary legislation governing medical devices is Prakas No. 1258, issued on November 8, 2012, which outlines the Procedures for the Registration of Medical Devices (referred to as ‘Prakas 1258’). In Cambodian law, a Prakas is an official proclamation.

International Associates Local Office In Phnom Phen can act as your Authorized Representative and guide you through the process.

Medical Device Classification:

Prakas 1258 categorizes medical devices into four classes based on risk levels:

Class A: Low-risk devices
Class B: Moderate-risk devices
Class C: High-risk devices
Class D: Very high-risk devices

Additional Regulations:

Medical devices in Cambodia are also subject to the following regulatory frameworks:

The Law on the Management of Pharmaceuticals
The ASEAN Medical Device Directive (AMDD)

As part of the ASEAN region, Cambodia is required to align with the AMDD, which standardizes medical device regulations across ASEAN member states, facilitating trade within the region.

Key Points on Registration:

Medical devices in Cambodia are also subject to the following regulatory frameworks:

No Product Grouping: Currently, Cambodia does not allow product grouping registrations for medical devices
Registration Process: While foreign manufacturers or product owners can be the license holders, only a locally registered company can submit the application for medical device registration. Foreign entities have two options:

1. Establish a Local Entity:

Obtain a Certificate of Incorporation from the Ministry of Commerce (MoC) and a pharmaceutical company license from the Ministry of Health (MoH).
Set up a local office with a registered pharmacist as the local representative.

OR

2. Appoint a Local Representative:

The foreign manufacturer or product owner can appoint a local representative in Cambodia such an International Associates Limited. We will then manage interactions with the DDF on your behalf.

Steps for Medical Device Registration:

1. Application Submission:

The local applicant must submit a registration application to the DDF.
Required documentation includes:
- Administrative Documentation: Hard copies of the marketing authorization application, Letter of Authorization (LoA), Declaration of Conformity (DoC), and ISO/GMP certificates.
- Technical File: A technical dossier demonstrating compliance with Prakas 1258, submitted in soft copy via USB drive.

2. DDF Review:

The DDF may request additional information during its review process. Once the evaluation is complete, the applicant will be notified to pay a government fee of KHR 400,000 (approximately USD $100). No VAT is applied to this fee.
The DDF holds committee meetings every three to four months to finalize approvals, though delays are common. If the evaluation isn't complete by the scheduled meeting, the application will be deferred to the next round.

3. Approval and Certification:

Upon approval, the DDF issues a registration certificate, valid for three years. Renewal requires a new application.

4. Important Considerations:

Manual Submission: Registration applications must be submitted manually.
Labeling Requirements: Medical devices must be labeled in Khmer or English.
Registration Timeline: The process typically takes between 12 to 18 months.

5. Compliance and Enforcement:

Only registered medical devices are permitted for import and sale in Cambodia, in accordance with Prakas 1258 and the Law on the Management of Pharmaceuticals. Registration ensures compliance with safety and quality standards, protects consumers from counterfeit products, and supports the legitimate medical device market

6. Penalties for Non-Compliance:

Importing unregistered medical devices can lead to severe penalties, including:

Fines up to KHR 10 million (approximately USD $2,500)
Imprisonment for up to one year
Confiscation of unregistered devices
A ban on further medical device imports

To avoid these risks, it is essential to register all medical devices with the DDF.

Need Assistance?

Navigating Cambodia's medical device regulations can be complex. Partnering with a knowledgeable local agency ensures compliance with all regulations and avoids potential penalties. For further clarification or assistance, please contact International Associates Limited.

For more information about our services please contact us by using our contact form, by phone or drop us an email. We will be pleased to assist you.

Alternatively get a quote by filling in our enquiry form

AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - CAMBODIA)

Medical Device Classification:

Prakas 1258 categorizes medical devices into four classes based on risk levels:

Additional Regulations:

Medical devices in Cambodia are also subject to the following regulatory frameworks:

Key Points on Registration:

Medical devices in Cambodia are also subject to the following regulatory frameworks:

1. Establish a Local Entity:

OR

2. Appoint a Local Representative:

Steps for Medical Device Registration:

1. Application Submission:

2. DDF Review:

3. Approval and Certification:

4. Important Considerations:

5. Compliance and Enforcement:

6. Penalties for Non-Compliance:

Need Assistance?

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