MEDICAL DEVICE REGULATION IN PHILIPPINES
Centre for Device Regulation, Radiation Health, and Research (CDRRHR) is now shifted to the Food and Drug Administration (FDA), from the Department of Health in the Philippines. CDRRHR's objective is to protect and promote the right to health of the Filipinos and to establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems. Medical devices are regulated under the Republic Act No. 9711, the Food and Drug Administration Act of 2009.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN PHILIPPINES
Only local establishments issued with a License to Operate (LTO) can register medical devices in the Philippines. The local medical device importer, distributor (importer, exporter, and wholesaler), trader and manufacturer are subjected to LTO by CDRRHR.
There are 2 types of certificate application in the Philippines relating to medical devices:
Certificate of Product Registration (CPR) for registrable medical devices including In-vitro Diagnostic Kits and Reagents
There is a list of registrable medical devices that are subjected to CPR. Products are also classified into 4 classes as Class A, Class B, Class C and Class D from the lowest risk to highest risk where the relevant fees are applicable.
Currently, there is a list of documents that are required to be submitted to CDRRHR, including the product testing reports. ASEAN CSDT dossier format is not mandatory currently until the new Administrative Order is implemented.
Proper planning on the documentation before submission is important because there will be increased fees or penalty for some application types if proper submissions are not made to CDRRHR.
Certificate of Exemption for Non-Registrable Medical Devices
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.