FDA Certificate of Product Notification (CPN)

The Certificate of Product Notification (CPN) is a requirement established by the Food and Drug Administration (FDA) Philippines. It aims to enhance consumer awareness of specific products falling under various categories, including Medical Device Notification, Cosmetic Product Notification, Toys and Childcare Articles Notification, and Product Batch Notification for Vapor Products and Heated Tobacco Products.

1. Medical Device Notification Procedure (applies to Low Risk, Class A medical devices):
   1. Fill out and submit the application form for product notification through the FDA Electronic Portal for pre-assessment.
   2. The FDA Philippines will review the application.
   3. If the application passes the pre-assessment stage, the FDA will issue an order of payment.
   4. Pay the applicable registration fee. Once the FDA cashier processes the payment, the application will undergo product evaluation.
   5. If the application is approved, the FDA will send an e-mail notification containing instructions on how and where to download the Certificate of Product Notification.
2. Cosmetic Product Notification Procedure (Cosmetic e-Notification):
   1. Complete and submit the application form for product notification through the FDA’s Electronic Portal.
   2. Pay the corresponding registration fee. Once the payment is received and verified by the FDA cashier, the application will proceed to product evaluation.
   3. If the application is approved, the FDA will send an e-mail notification containing instructions on how and where to download the Certificate of Product Notification.
   4. Applicants can download the FDA Memorandum Circulars and Cosmetic e-Notification Booklet from the FDA website for more detailed information about this procedure.
3. Toys and Childcare Articles Notification Procedure:
   1. Obtain a License to Operate (LTO) as a Health and Household (HUHS) Manufacturer, Trader, and Distributor (Exporter/Importer/Wholesaler).
   2. Complete the Notification Template for Toys and Childcare Articles, providing product information, a description of the toy, the product’s source, and other relevant details such as the manufacturer’s name, importer’s name, and the local company responsible for placing the product in the market. A declaration stating full responsibility for the product, reports of adverse events, and willingness to cooperate in post-marketing activities is also required.
4. Product Batch Notification for Vapor Products and Heated Tobacco Products (HTP) Procedure:
   1. Fill out the application form through the FDA Electronic Portal.
   2. Upload a copy of the product’s safety data sheet (SDS) in PDF format.
   3. Once the application is submitted, an assessment slip will be generated electronically for reference in the payment process.
   4. Pay the applicable fee. Once the FDA cashier processes the payment, the application will undergo evaluation.
   5. If the application is approved, the FDA will send an e-mail notification containing instructions on how and where to download the Certificate of Batch Notification.

Triple i Consulting, your trusted partner in the Philippines, is well-equipped with a team of experts ready to guide you through the intricate process of obtaining essential certifications from the Philippines FDA, such as License to Operate (LTO), Certificate of Product Registration (CPR), Certificate of Product Notification (CPN), Certificate of Medical Device Registration (CMDR), Certificate of Medical Device Notification (CMDN), and Clinical Trials (CT).

As pioneers in the industry, Triple i Consulting holds the distinction of being the first ISO 9001:2008 certified company in the Philippines to offer comprehensive business registration services. With our extensive experience and expertise in FDA applications, we are dedicated to assisting you every step of the way.

Why burden yourself with these complex tasks when you can rely on us? To schedule an initial consultation with one of our FDA experts, reach out through one of the following channels:

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