Product Registration
MEDICAL DEVICE REGULATION IN RUSSIA
Medical devices are regulated by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) from the Ministry of Health whose objective is to ensure that only quality and safe medical devices are introduced into the Russian market. Medical devices are regulated under the Decree of the Government of the Russian Federation No. 1416.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN RUSSIA
Medical devices are classified into 4 categories namely class I, IIa, IIb and III (I being the lowest risk and III being the highest risk).
Testing in accredited labs in Russia along with technical information submission is required in order to get the registration certificate. The local representative also needs to attain a Declaration of Conformity certification before the device can be imported.
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 Russia.
Drug Services
THERAPEUTIC AND COSMETIC APPROVAL
ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Russia.
Health Safety
WIRELESS, RADIATION AND PACKAGING APPROVAL
ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Russia.
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