Cambodia Medical Device Registration

Medical Device Registration in Cambodia: A Comprehensive Guide by the Department of Drugs and Food (DDF)

Regulatory Authority

Department of Drugs and Food (DDF)

Cambodia’s Department of Drugs and Food (DDF) regulates medical devices under Prakas No. 1258, which classifies them into four risk levels: Class A, Class B, Class C, and Class D.

The country also follows the Law on the Management of Pharmaceuticals and the ASEAN Medical Device Directive (AMDD), which sets harmonized standards for medical devices across ASEAN countries.

Link for Regulatory Authority

https://www.ddfcambodia.com/

Local Regulation

• ASEAN Medical Device Directive (AMDD)
• Prakas No. 1258 (8 November 2012)

Classification of Medical Devices

Class A, B, C and D

Listing or Registration Requirements: Medical Device Registration

• A Letter of Authorization is required to appoint the local importing partner.
• Even though DDF allows foreign manufacturers or product owners to be the license holder, only a local registered company can act as an applicant to submit the application for medical device registration.
• To register a medical device in Cambodia, the foreign manufacturer or product owner has 2 possibilities:

1. Set up a legal subsidiary entity
   1. Certificate of Incorporation from Ministry of Commerce (MoC) and pharmaceutical company license from Ministry of Health (MoH) are required.
   2. A local office is set up with a registered pharmacist as your local representative as per requirements.
2. Appoint a local representative: The manufacturer or product owner of the medical device can appoint a local representative in Cambodia. The local representative is responsible for dealing with the DDF on behalf of the manufacturer or product owner.

• The applicant of the medical device must submit an application to the DDF.
• The application must include the following documents:
  • Administration part: application form for marketing authorization, Letter of Authorization (LoA), Declaration of Conformity (DoC), Certificate of ISO/ GMP will be submitted in hard copy paper.
  • A technical file that demonstrates that the device meets the requirements of Prakas 1258 and CSDT template will be submitted in soft copy via USB
• The DDF will review the application and may require additional information.
• After the evaluation is completed, the applicant will be notified to pay the government fee of KHR 400,000 (around USD $100). There is no VAT for the government fee. DDF will conduct the committee meeting every three (3) to four (4) months to give final approval (delays are common). For applications that are not yet completed on the evaluation process at the prescribed committee meeting, the application will remain pending and will be continued until the next round. If the application is approved, the DDF will issue a registration certificate.
• Please take note of the following registration points in Cambodia: The submission route is manual.
  • The medical device must be labeled in Khmer or English.
  • The timeline for registration is between twelve (12) to eighteen (18) calendar months.
  • The registration certificate is valid for three (3) years.
  • To renew the registration, the manufacturer or local representative must submit a new application to the DDF.

Documents Required for Cambodia Medical Device Registration

• TECHNICAL DOCUMENTS for Medical Device Registration in Cambodia (Common Submission Dossier Template) (CSDT)

1. Executive Summary:
   1. Overview
   2. Commercial marketing history
   3. Intended uses and indications
   4. Regulatory approval
   5. Status of pending regulatory approval
   6. Important safety or performance information
2. Relevant Essential Principles and Method Used to Demonstrate Conformity
   1. Essential Principles and Evidence of Conformity
   2. Essential Principles of safety and Performance comprises of:
      1. General requirements of safety and performance that apply to all medical device
      2. Design and manufacturing requirements of safety and performance, some of which are relevant to each medical device

• Manufacturer determines the applicable essential principles and demonstrates conformity to each applicable essential principle

1. Conformity to essential principles is documented in a checklist format

3. Device Description
4. Summary of Design Verification and Validation Documents
   1. Pre-Clinical Studies
   2. Clinical Evidence
5. Device Labelling
6. Essential Principles

Registration Timeline

12 to 18 Months

Registration Fee

KHR 400,000(USD 100) per product, plus including 10% VAT

License Validity

3 Years

Special Labelling Requirements

Labelling should be done in the National language, Khmer.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

Prospects and Growth Trajectory: Cambodia’s Medical Devices Market Envisions Robust Expansion Until 2028

The Medical Devices market in Cambodia is poised to achieve a projected revenue of US$81,100.00k by 2024. Within the market’s diverse segments, an estimated US$11,970.00k is anticipated to secure the largest market share, projecting a market volume of US$110,100.00k in 2024. Looking ahead, the market is forecasted to observe a consistent annual growth rate of 7.94% from 2024 to 2028 (CAGR 2024-2028), culminating in a market volume of US$110,100.00k by 2028. 

Notably, in a global context, the United States is poised to generate the highest revenue, reaching US$182.00bn in 2024. The substantial growth in Cambodia’s medical device market is attributed to increased government investments in healthcare infrastructure and a rising demand for advanced medical technologies.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk