FDA Philippines Certificate of Product Notification

The Food and Drug Administration (FDA) Philippines established the Certificate of Product Notification (CPN) as a requisite for companies to provide consumers with a better awareness of certain products, specifically those under the Medical Device Notification, Cosmetic Product Notification, Toys and Childcare Articles Notification, and Product Batch Notification for Vapor Products and Heated Tobacco Products categories.

Medical Device Notification Procedure (this applies only for Low Risk, Class A medical devices):

• Accomplish and submit the application form for product notification through FDA Electronic Portal for pre-assessment.
• Wait for the FDA Philippines to review the application.
• If the application passes the pre-assessment stage, FDA will issue an order of payment.
• Pay the corresponding registration fee. Once the FDA cashier posts the payment, the application will go through product evaluation.
• If the application is approved, an e-mail notification from the FDA containing how/where to download the Certificate of Product Notification will be sent.

Cosmetic e-Notification, a.k.a. Cosmetic Product Notification Procedure:

• Accomplish and submit the application form for product notification through the FDA’s Electronic Portal
• Pay the corresponding registration fee. Once the FDA cashier posts payment, the application will go through product evaluation.
• If the application is approved, an e-mail notification from the FDA containing how/where to download the Certificate of Product Notification will be sent.
• To know more about this procedure, download the FDA Memorandum Circulars and Cosmetic e-Notification Booklet for Applicants at the FDA website.

Toys and Childcare Articles Notification Procedure:

• Secure an LTO as an HUHS Manufacturer, Trader, and Distributor (Exporter/Importer/Wholesaler).
• Fill out the Notification Template for Toys and Childcare Articles, including product information, description of the toy, source of the product, and all other pertinent information as to the name of the manufacturer, importer, and the local company responsible for placing the product in the market; and a declaration stating among others the full responsibility for the product, reports of adverse events and full cooperation on post-marketing activities.

Product Batch Notification for Vapor Products and Heated Tobacco Products (HTP) Procedure:

• Accomplish the application form through the FDA Electronic Portal.
• Upload a copy of the product’s safety data sheet (SDS).
• Documents must be in PDF file format.
• Once the application is submitted, an assessment slip will be electronically generated, which will serve as a reference for payment of the application.
• Pay the corresponding fee. Once the FDA cashier posts the payment, the application will go through an evaluation.
• If the application is approved, an e-mail notification from the FDA containing how/where to download the Certificate of Batch Notification will be sent.

Importing and selling an item in the Philippines can be tedious and time-consuming. It’s always best to seek assistance from regulatory experts. Triple i Consulting is an ISO-Certified company dedicated to helping clients get their products certified and approved by the Food and Drug Administration (FDA) in the Philippines in as little time as possible.

If you would like assistance obtaining an FDA Certificate of Product Notification, please contact us to book an initial consultation with one of our experts through any of the following methods:

• Contact Us here
• Fill out the form below
• Call us at +63 (02) 8540-9623
• Email us at info@tripleiconsulting.com