The Food and Drug Administration of the Philippines (PFDA) has released a new draft FDA Circular, "Guidelines on the Labeling Requirements for Medical Devices in the Philippines", proposing detailed requirements for the labeling of medical devices marketed in the Philippines. PFDA had previously proposed medical device labeling requirements through a draft Administrative Order, which sought to establish labeling requirements aligned with the ASEAN Medical Device Directive (AMDD).

The newly released draft FDA Circular follows the same general regulatory objective while providing a more detailed and operational framework for medical device labeling. The draft Circular provides more specific requirements on the placement of labeling information, additional requirements for particular device categories, electronic labeling, and regulatory actions for labeling non-compliance.

More Detailed Labeling and Placement Requirements

Under the proposed Circular, labeling information would be provided according to the device type, risk, intended purpose, intended user, and approved authorization. The required information includes, as applicable, the following:

• product name
• name and address of the FDA-licensed Marketing Authorization Holder (MAH)
• product registration/notification number
• physical manufacturer’s name and address
• intended purpose
• product code/model/variant
• batch or serial number
• expiration or manufacturing date
• warnings and precautions
• storage conditions
• other information necessary for the safe and appropriate use of the device

The draft Circular provides more detailed requirements on the appropriate placement of labeling information across the different levels of packaging and the Instructions for Use (IFU). Annexes B to E specify whether labeling information should be presented on the primary, secondary, or tertiary levels of packaging, and/or IFU, and indicate whether each item is required/mandatory, optional, or not applicable.

The draft Circular also provides additional labeling requirements for specific device categories. Separate provisions are provided for in-vitro diagnostics (IVDs), medical device software (MDSW), implantable, special purpose/use, refurbished, radiation-emitting, and single-use and reusable medical devices, as well as medical equipment and machines.

Electronic Labeling

The draft Circular provides detailed requirements for electronic labeling, including requirements for electronic IFUs (e-IFUs), version control, the availability of paper copies upon request, and manufacturer risk analysis for the implementation of electronic manuals.

The proposed requirements also address the accessibility of electronic information. A direct access mechanism, such as a QR code, barcode, or URL, would need to be provided on the device or packaging. Manufacturers would also need to ensure that the e-IFU can be downloaded or viewed offline and provide a customer support channel for users who experience difficulty accessing it.

Misbranding and Regulatory Actions

The draft Circular further establishes a structured approach to labeling non-compliance (misbranding/mislabeling). Labeling violations identified through post-market surveillance would be categorized as minor, major, or recurring/repetitive, depending on the nature and potential impact of the non-compliance on public health and safety.

Potential regulatory measures for major or recurring violations include product recall, suspension or termination of operations, revocation of authorization, temporary cessation of production, halt of importation and distribution, disapproval of pending applications, and enhanced monitoring or suspension of the establishment’s License to Operate (LTO).

Transition Period

Medical devices already registered and available in the Philippine market as of the effectivity of the Circular would be provided a two-year transition period to achieve full compliance. During this period, such devices may continue to be marketed, distributed, and sold until existing stocks are exhausted or until the end of the transition period, whichever comes first.

Key Takeaway

As the FDA Circular is still in draft form and open for comments, the proposed provisions are not yet effective PFDA labeling requirements and may still be revised before final issuance. Nevertheless, the draft reflects PFDA’s direction toward more detailed and specific labeling requirements for medical devices in the Philippines.

With 26+ years of experience supporting medical device and healthcare companies across Asia Pacific, Qualtech provides Regulatory Affairs, Product Registration and Authorized Representative (AR) services tailored to the Philippine market. Supported by our in-house Philippine team in Makati office, we help medical companies navigate registration requirements, regulatory communications and ongoing compliance obligations to support smoother market entry and long-term market presence.

Contact us to learn more about our market entry support solutions in the Philippines!

Reference

Draft FDA Circular – Guidelines on the Labeling Requirements for Medical Devices in the Philippines