Local authorised representative in Cambodia

The Department of Drug and Food (DDF) which is under the Ministry of Health (MOH) requires foreign manufacturers who have not set up their legal subsidiary to appoint a Local Authorized Representative (LAR), sometimes referred to as the in-country representative for product registration on behalf of the foreign manufacturers.

What are the (legal) requirements for a LAR in Cambodia?

The in-country representative must be a local licensed pharmaceutical company which has a Cambodian pharmacist name as the representative.

Can you appoint multiple marketing authorization holders or registrants in Cambodia?

How Andaman Medical can help with in-country representation in Cambodia:

As your in-country representative/ license holder/ registrant in Cambodia we will:

Represent your company in all dealings with the DDF and other authorities responsible for medical devices and in-vitro diagnostics including:

  • Registering your product
  • Dealing with all regulatory issues
  • Submitting change notification
  • Reporting Adverse Events
  • Ensure that the medical device or IVD is correctly labeled, and that information is provided in English
  • Maintain communication with the appointed distributor
  • Accept all calls from the FDA regarding the foreign manufacturer and its products and liaise accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
  • Obtaining advertisement permit if there are any advertising events/ activities.

Get a quote for in-country representation services in Cambodia

Cambodia’s Medical Device Market

The medical device market in Cambodia

Regulatory authority and laws governing medical devices in Indonesia

Medical devices are regulated by the Department of Drug and Food under the Ministry of Health through Regulation (prakas) No. 1258 (passed in November 2012).

Cambodia's healthcare system

Cambodia’s health care sector includes public and private hospitals with both non-profit and for-profit business models. The public sector delivers most preventive services and inpatient care, while private sector facilities tend to provide outpatient curative consultations.

In 2017, the Cambodian market spent about US $1.1 billion on general health care. The Ministry of Health is the single largest purchaser of drugs, medical supplies, and medical equipment in the country.

Industry associations

General economic and demographic statistics

How Andaman Medical can help you access the Cambodia medical device market

Regulatory Services for Cambodia

Market Access Services for Cambodia

Obtain a quote on accessing the Cambodia market

Post Market Surveillance of Medical Devices in Cambodia

The Department of Drug and Food requires foreign manufacturers to undertake post-market surveillance (PMS)  following the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read further to understand how post-market surveillance is implemented in Cambodia.  

What are the requirements for medical device PMS in Cambodia?

Following Annex 5 of the AMDD, the following is required as part of the post-market surveillance (PMS) in Cambodia:

Importation and/or Distribution records

Traceability is not only a requirement of an effective quality system but also the requirement of regulatory bodies around the world. Keeping proper and appropriate importation and/or distribution records is an important component of ensuring the traceability of medical devices in the market.

Complaint records

 An effective complaint handling system is an important part of any quality system. Any complaint received on a medical device should be evaluated and if necessary, thoroughly investigated and analyzed, and corrective actions should be taken. The results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences.

Adverse events

Several post-marketing risk assessment measures to ensure the continued safe use of medical devices may be undertaken. These measures include reporting from healthcare professionals, mandatory reporting from medical device dealers, and the exchange of regulatory information with other medical device regulatory agencies. The mandatory reporting of AEs by medical device dealers is an important part of the post-market surveillance system. The objective of AE reporting and subsequent evaluations is to improve the protection of the health and safety of patients, users, and others by disseminating information that may reduce the likelihood of, or prevent the repetition of AEs, or alleviate the consequences of such repetition.

Field Safety Corrective Action (FSCA)

 An FSCA is required when it becomes necessary for the product owner of the medical device to take action (including recall of the medical device) to eliminate or reduce the risk of, the hazards identified. An FSCA may still be necessary even when the medical device is no longer on the market or has been withdrawn but could still possibly be in use (e.g. implants). An FSCA only applies to a medical device that has already been distributed by the product owner. It does not arise when a product owner is exchanging or upgrading medical devices in the absence of a safety risk or when removals from the market are for purely commercial reasons.

Adverse Event Reporting Timeline

All adverse events (AEs) should be reported immediately and;

How Andaman Medical can help you with post market surveillance in Cambodia

With 8 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse events and FSCA mandatory reporting. Our local, in-house staff liaise with the Food and Drug Administration to help you maintain compliance once your medical device is placed on the market. Our services include:

Get a quote on our PMS services in Cambodia

Medical device importation to Cambodia

Only registered medical devices may be imported into Cambodia, which means they must be registered with the Department of Drug and Food (DDF) and be issued with a Medical Device Registration License. Any Company wishing to import medical devices and in-vitro diagnostic (IVDs) must have a valid Certificate of Corporate and Import-Pharmaceutical License from the Authority.

What are the requirements for importing medical devices into Cambodia?

Are there any exemptions or exclusions?

Special Access Routes for importing medical devices into Indonesia

Special cases where special permits/certifications/exemptions are issued for unregistered medical devices:

  • Compassionate Special Permit (CSP)
  • Emergency use such as during the COVID-19 pandemic

Importers' duties and obligations

It is mandatory for importers of medical devices and IVDs to Cambodia to:

How Andaman Medical can help with importing medical devices to Cambodia:

Acting as your independent local authorized representative or marketing authorization holder in Cambodia, we will work with your license importers to:

We also offer additional support services such as:

Obtain a quote on accessing the Cambodian medical device market

How to register medical devices in Cambodia

All medical devices, whether manufactured domestically in Cambodia or imported, must be registered with the Department of Drug and Food (DDF) under the Ministry of Health.

Who can register a medical device in Cambodia?

To be able to register medical devices and in vitro diagnostic (IVD) in Cambodia, the company must first obtain their Certificate of Corporate from the Ministry of Commerce (MoC), then legally registered their company at the Ministry of  health (MoH).  To obtain the local pharmaceutical company license,  the company must have a Cambodian pharmacist name to be their representative in the license.

For foreign manufacturers, there are 3 possibilities to register their medical devices and IVD in Cambodia:

Set up a legal subsidiary entity

To register the medical device, a Certificate of Corporate from (MOC) and pharmaceutical company license from (MOH) is required. A local office set up and having a local pharmacist representative is a must.

Appoint a local distributor

That has a valid Certificate of Corporate and Pharmaceutical company license to register the medical devices.

Appoint an independent third party

Such as Andaman Medical to register the medical device. Andaman Medical has a valid Certificate of Corporate and Pharmaceutical company license which can act directly as a local authorized representative and can register all classes of medical devices: A, B, C, and D on behalf of foreign manufacturers. We handle all regulatory issues, and maintaining your license, so you can appoint any importer or distributor without affecting your product license once the distributorship change.

Classification of medical devices in Cambodia

The medical device in Cambodia are classified in terms of risk  following the ASEAN Medical Device Directive (AMDD), which lists 4 classes:

Class A, Low Risk

Class B, Low to Moderate Risk

Class C, Moderate to High Risk

Class D, High Risk

The risk presented by a medical device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during the design, manufacture, and use. Hence, the risk classification depends upon the design and claims made by the product owner and on its intended purpose.

The Department of Drug and Food (DDF) will follow the classification (A,B,C,D) of the device according to the manufacturer/ product owner stated in the dossier.

Medical device grouping in Cambodia

Currently, there is no “product grouping” available in Cambodia. An application must be made separately for each specific medical device.

The registration process

Registration application of all classes of medical devices and IVDs are manually submitted to the Drug Registration Bureau in DDF. The dossier shall be submitted in soft copy (USB flash drive) along with a hard copy application form and some  required documents. The authority officer responsible for dossier evaluation will do the pre-assessment. Should all the submitted documents comply with the checklist, payment will be requested. After the payment is done, the application details and device data will be recorded in the Drug Registration Bureau internal system. Evaluation process will continue with many ranks of officers till completed at the Secretary of State (MOH) office. The final approval will be conducted every 3 months, however, delays on the schedule are common in Cambodia.

What documents are required to register medical devices in Cambodia?

Various documentation is required to register a medical device in Cambodia. Only Cambodian and English languages are accepted.

In general, you will be required to submit a Common Submission Dossier Template (CSDT):

a) Executive Summary

b) Relevant Essential Principles and Methods Used to Demonstrate Conformity

c) Device Description

d) Summary of Design Verification and Validation Documents

e) Device Labeling

f) Risk Analysis

g) Manufacturer Information

Documents that are mandatory to submit along are:

  1. Certificate of GMP or Certificate of ISO from the Country of Origin
  2. Certificate of Free Sale from the Country of Origin
  3. Certificate of Analysis from the Country of Origin
  4. Declaration of Conformity Letter
  5. Letter of Authorization

Typical fees and timelines

A fee is payable for each new medical device registration and renewal.

The registration fee and timeline apply the same to all classes of medical devices and IVD.

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

How Andaman Medical can help:

Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics in Southeast Asia.

Our in-house team of local, experienced regulatory affairs specialists will register your medical device in Cambodia. 

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Obtain a quote to register medical devices in Cambodia

Medical device distribution to Cambodia

Only registered medical devices may be imported into Cambodia, which means the medical devices must be registered with the Department of Drug and Food (DDF) and have been issued with a Medical Device Registration License.

Who can distribute medical devices in Cambodia?

What are the requirements for distributing medical devices in Cambodia?

Advertising rules

Advertising, communication, and promotion of medical devices are a common part of a distributor contract. Please note that any advertising activities must be applied for an advertisement license from the Department of Drugs and Food (DDF). The fee and validity depend on the advertising materials and activities.

Distributor’s duties and obligations

It is mandatory for distributors of medical devices and IVDs in Cambodia to:

Obtain a quote on accessing the Cambodian medical device market

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