Product Registration
MEDICAL DEVICE REGULATION IN CAMBODIA
Medical devices are regulated by the Department of Drugs and Food (DDF) in the Ministry of Health in Cambodia whose objective is to ensure the quality and safety of medical devices that are locally produced or imported from other countries. They follow regulations that are in line with the ASEAN Medical Device Directive (AMDD).
MEDICAL DEVICE REGISTRATION AND APPROVAL IN CAMBODIA
Recently, DFF clarified that the License Holder and Manufacturer can be a foreign company. But the registration dossier must be submitted by a local licensed pharmaceutical importer that employs a Cambodian pharmacist.
The local pharmaceutical importer can prepare, sign and submit the application dossier, liaise with the DDF on the dossier, and receive the product registration certificate, all on behalf of the foreign manufacturer.
Medical devices are classified into 4 categories namely class A, B, C and D (A being the lowest risk and D being the highest risk).
If the classification has not yet taken place in any ASEAN jurisdiction, we would need to classify the product first by visiting the DDF. Lastly, please note family registration for medical devices is not available in Cambodia.
Registration timeline usually takes six to twelve months, but delays are common. Sometimes authorities exercise their discretion during registration and delay procedures in an effort to solicit unofficial payments. Since we are bound by our firm’s zero-tolerance anti-corruption policy, we are strictly prohibited from making any unofficial payments to expedite action from the authorities.
Example Of Approval
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License Holding
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.
Extra RA/QA Support
MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION
ARQon provide onsite/offsite monthly regulatory support for regional registration in Cambodia.
Drug Services
THERAPEUTIC AND COSMETIC APPROVAL
ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Cambodia.
Health Safety
WIRELESS, RADIATION AND PACKAGING APPROVAL
ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Cambodia.
ត្រូវការព័ត៌មានលម្អិតបន្ថែមទេ? ទាក់ទងមកពួកយើង។
យើងនៅទីនេះដើម្បីជួយ។ ទាក់ទងមកយើងនៅ ATTOPOLIS Platform ។
