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