Philippines Medical Device Labeling

Philippines Labeling (ASEAN Harmonized) 

Labeling in the Philippines is guided by Guidelines on the Labeling Requirements for Medical Devices in the Philippines and is largely harmonized with the ASEAN MDD (AMDD).

General Labeling Principle under the AMDD: The label found on the device should be a reasonable size for the type of device and should contain as much information as possible for the user to be able to identify and safely use the product. Depending on the size, additional information can be included inside the packaging, and/or on the Instructions for Use (IFU). IFUs may not be needed for all classifications of devices, such as low or moderate risk products.

Depending on the products classification and who will be using the product, the labeling will need to be written in English and/or Filipino and will be reviewed as part of the application review process.

The CDRRHR has provided more information on how manufacturers and local distributors can maintain compliance during the CMDN to CMDR transition. Labeling applied to medical devices that have been approved under Certificate of Medical Device Notification (CMDN) but are now under a Certificate of Medical Device Registration (CMDR) will need to reflect this change. Please visit our blog on this topic for more information.

Independent License Holders have the ability to label medical devices for their customers through the 3PL Value Added Service (VAS). Labels can be affixed to medical devices after customs clearance.

Labeling Components

Product labeling is part of the official review process and typically contains the following components:

1. Product Owner Name, Address and Tel. No.
2. Trade or Brand Name
3. Details for identifying device
4. Batch and Lot No.
5. Expiration date (if applicable)
6. Sterile or Non-Sterile
7. Warnings regarding malfunctions, precautions, proper disposal
8. Additional product and tech specific requirements, i.e. single use only, implantable devices, radiation emitting, custom made, non-clinical use, refurbished devices, devices using or administering medicine, etc.

IVD Specific Requirements

IVD products must adhere to additional requirements on top of the above outlined Medical Device guidelines.

IVD products will also need to include:

• Intended Purposes (type of analyte of the assay, qualitative vs. quantitative, etc.
• Intended Purposes (type of analyte of the assay, traceability information)
• Test principle
• Assay procedure, including calculation and interpretations
• Specimen type
• Performance characteristics
• Conditions for collections
• Reference Intervals
• Reagent description and any limitation
• Study design

For HIV test kit, a stick-on label indicating “For DOH accredited 19 laboratory use only” as per Republic Act No: 5804.

Labeling Requirements for Customs Clearance

Manufacturers will also need to be wary of the local labeling requirements and expectations at the port of entry. In the Philippines, Manufacturers can apply their country-specific label in country, once it’s passed through customs.

Contact Asia Actual if you have questions about medical device and IVD device labeling in the Philippines.