Philippines Medical Device Labeling: Compliance with ASEAN MDD and Local Requirements

Philippines Medical Device Labeling Requirements

Labeling for medical devices and In Vitro Diagnostic (IVD) devices in the Philippines is regulated by the Center for Device Regulation, Radiation Health and Research (CDRRHR) and is largely harmonized with the ASEAN Medical Devices Directive (AMDD). The labeling is a mandatory part of the Certificate of Medical Device Notification (CMDN) or Registration (CMDR) application review process.

General Labeling Principles and Language

The core principle is that the label should be of a reasonable size for the device and contain sufficient information for the user to safely identify and use the product.

• Language: Depending on the device's classification and its intended user, the labeling must be written in English and/or Filipino.
• Supplementary Information: If the size of the device limits the amount of information on the label, additional details can be included inside the packaging or in the Instructions for Use (IFU). Lower-risk devices may not require an IFU.
• Regulatory Status: Labeling must reflect the device's current authorization status (CMDN or CMDR). Manufacturers must ensure compliance during the transition between these certificate types.

Required Labeling Components

Product labeling must include the following essential information:

1. Manufacturer/Product Owner Details: Name, Address, and Telephone Number.
2. Product Identification: Trade or Brand Name, Batch and Lot Number.
3. Use and Safety:
   • Expiration Date (if applicable).
   • Sterile or Non-Sterile status.
   • Warnings regarding malfunctions, precautions, and proper disposal.
4. Device-Specific Requirements: Including indications such as single use only, implantable devices, radiation emitting devices, custom-made devices, and devices that use or administer medicine.

IVD-Specific Labeling Requirements

In addition to the general requirements, IVD products must include supplementary details related to the diagnostic assay:

• Intended Purposes: Including the type of analyte, whether the test is qualitative or quantitative, and traceability information.
• Assay Procedure: Detailed test principle, procedure, including calculation methods and interpretations.
• Performance Characteristics and conditions for collections.
• Specimen Type and Reference Intervals.
• Reagent Description and any known limitations.

Note: For specific products like HIV test kits, there is a local requirement for a stick-on label indicating, “For DOH accredited laboratory use only” (as per Republic Act No. 5804).

Post-Customs Labeling

Manufacturers may apply their country-specific label in-country after the device has passed through customs clearance. Independent License Holders can offer local labeling services through a 3rd Party Logistics (3PL) Value Added Service (VAS).