Authorized Representative for Medical Devices – Cambodia
In Cambodia, the regulation of medical devices is overseen by the Department of Drugs and Food (DDF) under the Ministry of Health. The primary legislation governing medical devices is Prakas No. 1258, issued on 8 November 2012, which sets out the official procedures for the registration of medical devices. In Cambodian law, a Prakas is an official governmental proclamation.
For manufacturers looking to place medical devices on the Cambodian market, appointing a local Authorized Representative is essential to ensure compliance with regulatory requirements. International Associates Limited, through its local office in Phnom Penh, provides professional Authorized Representative services, guiding manufacturers through registration, documentation, and ongoing compliance obligations in Cambodia.
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
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.