Cambodia Medical Device Regulation
Medical devices in Cambodia are regulated by the Department of Drugs and Food (DDF) under the Ministry of Health. The main legislation that specifically regulates medical devices is Prakas No. 1258 (8 November 2012) on the Procedures for the Registration of Medical Devices (hereafter as ‘Prakas 1258’). Prakas is a Cambodian term which means official proclamation.
Prakas 1258 classifies medical devices into four (4) categories, based on their risk:
- Class A: Low risk devices
- Class B: Moderate risk devices
- Class C: High risk devices
- Class D: Very high-risk devices
In addition to Prakas 1258, medical devices in Cambodia are also subject to the following regulations:
- The Law on the Management of Pharmaceuticals
- The ASEAN Medical Device Directive (AMDD)
The AMDD is a regional regulation that sets harmonized standards for medical devices in ASEAN countries. Cambodia is required to comply with the AMDD to trade medical devices with other ASEAN countries.
Currently there is no product grouping registration in Cambodia.
- Medical Device registration:
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:
- Set up a legal subsidiary entity:
- Certificate of Incorporation from Ministry of Commerce (MoC) and pharmaceutical company license from Ministry of Health (MoH) are required.
- A local office is set up with a registered pharmacist as your local representative as per requirements.
- 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 following steps must be taken to register a medical device in Cambodia:
- 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 drive.
- 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’s 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.
What you need to know:
- According to Prakas No. 1258 and the Law on the Management of Pharmaceuticals, only registered medical devices are allowed to be imported and sold in the Cambodian market.
- There are several reasons why it is important to register medical devices before importing them into Cambodia: First, it ensures that all medical devices meet the required safety and quality standards.
- Second, it helps to protect consumers from counterfeit and substandard medical devices.
- Third, importing unregistered medical devices can disrupt the legitimate medical device market in Cambodia.
- Importing an unregistered medical device into Cambodia may be subjected to the following penalties:
- A fine of up to KHR 10 million (around USD $2,500)
- Imprisonment for up to one (1) year
- Confiscation of the medical devices
- A ban on importing medical devices into Cambodia.
Therefore, it is essential to ensure that all medical devices sold or imported into Cambodia are registered with DDF.
It is important to consult with a local agency that is familiar with the regulations. They can help you ensure that you meet compliance regulations and laws to avoid the risk of penalties. If you need more clarification, please reach out to Andaman Medical through email@example.com.