To align the regulations in the Philippines with the ASEAN Medical Device Directive (AMDD), the Department of Health (DOH) has issued new guidelines that govern the notification or registration of medical devices with the Food and Drug Administration (FDA) prior to importation, exportation, marketing, manufacture, and distribution in the Philippines.
Implications for medical device companies
Medical device companies may not import, export, manufacture, distribute or market their medical devices in the Philippines unless these are notified to or registered with the FDA, depending on the risk classification of the subject medical device. Previously, only medical devices specifically identified by the FDA in a list of registrable medical devices, require registration. Medical device companies must now determine the risk classification of the medical devices that they distribute in the Philippines, and comply with the applicable requirements for notification or registration. Risk classifications will be identified by the FDA in a subsequent issuance.
What the regulation says
DOH Administrative Order No. 2018-0002 entitled: "Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements" (Guidelines) adopts a classification system for medical devices according to their level of risk as provided below:
|B||Low to Moderate|
|C||Moderate to High|
A guidance document containing the list of medical devices for each classification shall be issued by the FDA. Class A devices must be notified to the FDA. Class B, C, and D devices must be registered with the FDA. Medical devices strictly for research, clinical trial, exhibit and/or donated brand new medical devices are exempt from notification and registration. However, the researcher, institution and/or user of such devices must apply for a Certificate of Medical Listing (CMDL) from the FDA.
Successful notification to the FDA is evidenced by a Certificate of Medical Device Notification (CMDN), and successful registration is evidenced by a Certificate of Medical Device Registration (CMDR). The Guidelines list the documentary requirements to be submitted to the FDA, and the process and timeline, to obtain a CMDN, CMDR, and CMDL. The Guidelines took effect on 30 March 2018, and will be implemented one year thereafter.
Implementation of the Guidelines will start in March 2019. Implementation shall initially cover (i) all products under the latest list of medical devices currently required to be registered with the FDA, (ii) Class A medical devices requiring notification and (iii) those for medical device listing.
The requirement for registration of medical devices not indicated in the current list of registrable medical devices shall be implemented in phases as follows:
- Phase 1: Notification of Class B, C, and D that are non-registrable devices under the current FDA list
- Phase 2: Registration of Class D devices, and notification of Class D devices shall cease during this phase.
- Phase 3: Registration of Class B and Class C, and notification of Class B and Class C devices shall cease during this phase.
The Guidelines provide for a new regulatory framework for notification or registration of medical devices prior to their importation, export, manufacture, distribution, and marketing in the Philippines. To ensure compliance with the Guidelines:
- Medical device companies with medical devices that are currently registered with the FDA should familiarize themselves with the new requirements and procedures for registration under the Guidelines to allow sufficient time for preparation and compliance.
- Medical device companies with products that are not covered by the requirement to register under previous regulations must determine their products' risk classification and the corresponding notification or registration requirement for such products.
- Users of medical devices for research, clinical trial, exhibits or which are subject of donations should ensure that the products are covered by a CMDL.
- All medical device companies should review safety and efficacy documents for their medical devices, and take steps to ensure that these products comply with the appropriate requirements and supporting documents for notification or registration, as the case may be, under the Guidelines.