While changes in accordance with the AO 2018-0002 are to be implemented beginning April 1, 2019, the current medical device regulations in the Philippines require manufacturers to apply for and obtain a Certificate of Product Registration (CPR) or a Certificate of Exemption (COE) prior to a device being imported and placed on the market. FDA Memorandum Circular No. 2014-005 identifies devices subject to the more thorough CPR review.
Most medical 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 CPR takes 180 days to process. FDA processing fees total US$35. Initial CPR 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.
New guidance to streamline the submission process for CPR amendments has been released. Qualifying CPR amendment applications can be grouped together in a single submission. For example, a change to the legal manufacturer’s address that applies to 20 CPRs may now be submitted at one time.
Medical 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 US$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 conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
Radiation-emitting medical devices, such as X-ray machines, MRIs, and ultrasound scanners, are subject to a new customs clearance release procedure administered by the Philippine FDA. Importers must obtain a Clearance for Customs Release (CFCR) certificate issued by the FDA’s CDRRHR. Applicants will be processed within 3 working days for a fee of US$6 per device. A certificate of product registration issued by the national authority in the country of origin and authenticated by the Philippines embassy is required.
New Regulations (for implementation April 1, 2019)
With efforts to harmonize the Philippine Regulatory Guidelines in accordance with the ASEAN Medical Devices Directive, the Philippines Department of Health recently released Administrative Order 2018-0002. The AO introduces risk classification of medical devices, as well as new requirements for initial device registration and renewal.
The Philippines Department of Health published new medical device registration fees. Medical devices will be classified by increasing risk from A to D. The CDRRHR shall release the list of medical devices per classification based on the classification set forth in the ASEAN Medical Device Directive. IVDs are not included in this classification and a separate Administrative Order is set to be issued for IVDs. The new registration fees will have three components that vary by risk classification as below:
Class A Notification PhP 5,000 PhP 10,000 Php 2,000
Class B Registration PhP10,000 PhP 20,000 PhP 5,000
Class C Registration PhP 15,000 PhP 45,000 PhP 9,000
Class D Registration PhP 30,000 PhP 60,000 PhP 12,000
The Philippines Department of Health has launched new medical device regulations as announced in Administrative Order 2018-0002. This new system will be implemented in phases. For starters, all Class A devices will be required to obtain a Certificate of Medical Device Notification (CMDN). The same requirement applies to new registration applications for notified devices (those that previously required Certificate of Product Registration). Manufacturers or their local authorized agents should have a 12-month grace period to comply before losing market access. All current Certificates of Product Registrations (CPR) will remain valid until their expiry date.
In Phase I, all non-notified Class B, C, and D devices will be required to obtain a CMDN. Phase II will require Class D devices to meet Certificate of Product Registration (CMDR) standards. Finally, in Phase III all Class B and C devices will be required to obtain a CMDR. The Notification Number or Registration Number will be issued to the device with an approved CMDN or CMDR, respectively. Both the CMDN and the CMDR will be valid for 5 years.
Contact Asia Actual for assistance with your medical device registration 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.