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?

  • No, in Cambodia, one device is allowed to register by only one registrant per time.
  • Foreign manufacturers need to issue a letter of authorization (LOA) to appoint /authorize the registrant to register their product.
  • The registrant can be changed during renewal.
  • The foreign manufacturers can be a license holder, but the registration dossier must be submitted by a local licensed importer that employs a Cambodian pharmacist. The foreign manufacturer can appoint either themselves or their local distributor as the license holder /marketing authorization holder.

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.

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Cambodia’s Medical Device Market

The medical device market in Cambodia

  • Cambodia's market for medical device imports is growing, doubling in size between 2015 and 2020 according to health professionals. The establishment of new private hospitals has boosted the demand for quality machinery.
  • Cambodia depends heavily on imported devices since local production is not available.
  • Available data suggest that, between 2008 and 2018, imports of medical instruments grew by about 57%, while imports of medical X-ray machines increased by 162%.
  • In addition, the government has recently made available funds to purchase medical devices to supply public hospitals. The government’s strategy is to reduce the gap between the public sector and the best private hospitals. To this end, several public tenders have been announced, focusing on in-vitro diagnostic devices and medical imaging devices.

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

  • The current population of Cambodia is 17,205,513 as of August 11, 2022, based on Worldometer elaboration of the latest United Nations data.
  • Cambodia ranks number 71 in the list of countries (and dependencies) by population. The population density in Cambodia is 95 per Km2 (245 people per mi2). The 24.2 % of the population is urban (4,050,459 people in 2020). The median age in Cambodia is 25.6 years
  • Cambodia has made considerable strides in improving health outcomes, early childhood development, and primary education in rural areas. Life expectancy at birth has risen from 58 years in 2000 to 70 years in 2020.
  • Cambodia’s GDP growth is expected at 5.3% in 2022 and 6.5 % in 2023 according to ASIAN Development Bank.
  • Cambodia has made considerable strides in improving health outcomes, early childhood development, and primary education in rural areas. Life expectancy at birth has risen from 58 years in 2000 to 70 years in 2020.

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

Regulatory Services for Cambodia

Medical Device Registration

Local Authorised Representative

Post Market Surveillance

Intelligence Reports

Training

Market Access Services for Cambodia

Importation

Distribution

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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;

  • Not later than 48 hours for events that represent a serious threat to public health;
  • Not later than 10 days for events that have led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device, or any other person;
  • Not later than 30 days for events where a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device, or any other person

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:

  • Support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
  • Identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
  • Evaluate your PMS data to ensure that existing processes and outputs are fully compliant
  • Monitor and report on any regulatory changes to ensure ongoing compliance

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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?

  • To import medical devices and IVDs, the company first must obtain a Certificate of Corporate as a business license and must register the company as an Import-Export Pharmaceutical Company at the Ministry of Health.
  • The company also must hold a valid Medical device registration license.
  • For shipment of importation, the company must apply for an import license from MOH first to process clearance at customs. In 2019, the Ministry of Health announced to participate using the Cambodia National Single Window (CNSW) portal launched by the Ministry of Economics to apply for an import license.
  • Currently, only Cambodian companies can import and apply for an import license.

Are there any exemptions or exclusions?

  • Certain products may be imported using Special Access Routes (see below).

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:

  • Maintain a record of all imports
  • Keep all certificates of analysis of the devices
  • Provide appropriate storage conditions to maintain the safety and quality of imported products
  • Maintain valid product registration certificates

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:

  • Authorize your selected importers to import your devices into Cambodia.
  • Ensure that your license maintains post-marketing surveillance of your registered product.
  • Liaise with your license importer concerning the mandatory reporting of Adverse Events and Product Calling.

We also offer additional support services such as:

  • Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.

Obtain a quote on accessing the Cambodian medical device market

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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:

  • Standard product registration
  • Abridged product registration
  • Special access product registration
  • Renewal of product registration
  • Amendment and change notification
  • Product license transfer

Our authorised representative services include:

  • Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
  • Regulatory monitoring to alert you to any changes or new regulation applicable to your product
  • License holding
  • Adverse event reporting and management
  • Product alert and recall tracking
  • Complaint handling

We also offer additional support services such as:

  • Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
  • Relabelling

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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?

  • Only Cambodian companies who hold a valid Certificate of Corporate and Import-Export Pharmaceutical company license may distribute in Cambodia.
  • What is important to remember is that multiple importers and distributors may be appointed in Cambodia as long as the agreement between the manufacturer and the distributor is non-exclusive. This means you can have several distribution channels available to you at any one time.
  • The advantage in Cambodia, the distributor or importer doesn't need to be a license holder. The foreign manufacturers can be license holder, but the registration dossier must be submitted by a local licensed importer that employs a Cambodian pharmacist. . However, the best way to be hassle-free is to appoint a third-party agent to act as LAR so you can switch distributor networks without affecting the product license.

What are the requirements for distributing medical devices in Cambodia?

  • To distribute medical devices, the company must have a Certificate of Corporate for business and an Import-Export Pharmaceutical license.
  • A valid product registration license is also mandatory.

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:

  • Maintain a record of all imports and exports
  • Maintain a valid product registration license
  • Maintain records of any complaints
  • Report any Adverse Events (AE) or Field Safety Corrective Actions (FSCA) to the Department of Drug and Food (DDF) as well as to the Local Authorized Representative
  • Comply with Good Distribution Practice regulation.

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Regulatory Services

Market Access Services

Target Markets

Insights

About us

Contact Us

Linkedin Twitter Facebook

Copyright 2023 © Andaman Medical | Privacy Policy
Web Design by Brilliant Digital

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