Table of Contents
Medical Device registration in Cambodia
Click here to visit Cambodia DDF (Authority) website.
Cambodia’s Department of Drugs and Food (DDF), which is part of the Ministry of Health, is the department in Cambodia government responsible for medical device registration, and they follow regulations that are in line with the ASEAN Medical Device Directive (AMDD).
The License Holder and Manufacturer named on the registration certificate can be a foreign company. However, a registration dossier may shall only be submitted by a local licensed importer that has a licensed pharmacist.
This means a local importer can prepare, sign and submit the application dossier, communicate with the DDF on the dossier, and receive the product registration certificate, all on behalf of the foreign manufacturer that is named as the License Holder and/or Manufacturer on the product certificate.
Once the product registration certificate is issued, the foreign manufacturer may opt to work with any local importer it wishes, to engage in the actual import and distribution of the product.
Cambodian authorities normally follow the classification of the product under other ASEAN jurisdictions (AMDD). However the DDF may reclassifies the product if they wished to do so.
Currently official government filing fees for medical device registration are about USD 100 per product, not including 10% VAT.
Once the medical device registration certificate is obtained, the client can appoint any local licensed import company to apply for import permits per shipment, import the products into Cambodia and distribute the products.
A Letter of Authorization is required to appoint the local importing partner.
Latest Sep 2020
CSDT requirements has been implemented as below.
TECHNICAL DOCUMENTS for Medical Device Registration in Cambodia
(Common Submission Dossier Template) (CSDT)
A- Executive Summary
1-Overview
2-Commercial marketing history
3-Intended uses and indications
4-Regulatory approval or marketing clearance obtained
5-Status of pending regulatory approval
6-Important safety or performance information
B-Relevant Essential Principles and Method Used to Demonstrate Conformity
Essential Principles and Evidence of Conformity
– Essential Principles of safety and Performance comprises of:
– General requirements of safety and performance that apply to all medical device
– 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
– Conformity to essential principles is documented in a checklist format
C- Device Description
– Device description & features, -Intended use, -Indications of use
– Instructions of use, -Contraindications, – Warnings, – Precautions
– Potential adverse effects, – Alternative therapy, -Materials
– Other relevant specifications, -Other descriptive information
D-Summary of Design Verification and Validation Documents
– Pre-Clinical Studies
– Clinical Evidence
E- Device Labelling
Some explanation below for CSDT meant for medical device registration in Cambodia
Executive Summary
An executive summary shall be provided with the common submission dossier template, which shall include the following information:-
• an overview, e.g., introductory descriptive information on the medical device, the intended uses and indications for use of the medical device, any novel features and a synopsis of the content of the CSDT;
• commercial marketing history;
• intended uses and indications in labelling;
• list of regulatory approval or marketing clearance obtained.
• status of any pending request for market clearance; and
• important safety/performance related information.
Essential Principles
The CSDT should identify the Essential Principles of Safety and Performance of Medical Devices that are applicable to the device. The CSDT should identify the general method used to demonstrate conformity to each applicable Essential Principle. The methods that may be used include compliance with recognized or other standards, state of the art or internal industry methods, comparisons to other similar marketed devices, etc.
The CSDT should identify the specific documents related to the method used to demonstrate conformity to the Essential Principles.
Intended Use
This means the use for which the medical device is intended, for which it is suited according to the data supplied by the product owner in the instructions as well as the functional capability of the device.
Click here to contact us for more information on medical device registration in Cambodia.
