Philippines IVD device registration is managed by the Center for Device Regulation, Radiological Health and Research (CDRRHR) of the Food and Drug Administration (FDA) within the Department of Health (DOH). While changes are anticipated at the beginning of 2016, the current Philippines IVD device regulations require manufacturers to apply for and obtain a Certificate of Product Registration (CPR) or a Certificate of Exemption (COE) prior to the device being imported and placed on the market. FDA Memorandum Circular No. 2014-005 identifies devices subject to the more thorough CPR review.
Most IVD devices will require a Certificate of Product Registration. Proof of regulatory approval in the country of origin is a required, but reference country approval (from the US, EU, Canada, Japan or Australia) may be used instead. Certain documents such as the Free Sale Certificate, ISO certificate and Foreign Agency Agreement must be authenticated by the territorial Philippine Consulate. Obtaining authentication can take 4 to 12 weeks and is often the bottleneck in the regulatory submission. The initial application for PRC takes 180 days to process. FDA processing fees total US$35. Initial PRC are valid for 1 year. Reregistration certificates are then valid for 5 years and can be processed in 60 to 90 days with no variation in application data. Otherwise the reregistration process will take 180 days. The FDA fee for registration is US$115.
IVD devices that do not require a CPR, must obtain a Certificate of Exemption (COE). The application processing requires 2 to 4 weeks with FDA fees of $12. A COE will be valid until new regulatory guidelines are published.
Applications must be submitted by and subsequent CPR are held by a licensed importer, distributor or manufacturer. The License To Operate of the importer, distributor or manufacturer must be up-dated with the foreign manufacturing source data. The amendment process to the LTO takes 4 to 8 weeks and carries government fees of US$90.
Quality systems confirmity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
Contact Asia Actual for assistance with your IVD device registation in the Philippines or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, top level consultants in the Philippines to manage the application process.