Advertising Requirements Overview
All medical device advertisem*nts in the Philippines will need to be reviewed prior to placing in the marketplace including those meant only for Healthcare Professionals. Advertisem*nts will need to be reviewed by the Ad Standards Council and/or the Philippines FDA depending on the content. All non-promotional advertisem*nts will need to submit through the Ad Standards Council (ASC) and their requirements can be found here. The Ad Standards Council is the advertising industry body in charge of screening and regulating content of advertising materials across all mediums and more information can be found here. Medical devices applications will then be referred to the FDA for their review and approval.
On the other hand, advertisem*nts that offer prizes or rewards for purchasing will need to obtain a Sales Promo Permit. More information on this process can be found below.
Sales Promo Permit Requirements
Sales promotion materials that offer rewards or prizes will need to apply for a Sales Promo Permit which is typically reviewed within 1 month. Advertisem*nts will require a Sales Promo permit if it meets the following definition:
“Sales Promotion” means techniques intended for broad consumer participation which contain promises of gain such as prizes, in cash or in kind, as reward for the purchase of a product, security, service or winning in contest, game, tournament and other similar competitions which involve determination of winners, and which utilize mass media or other widespread media of information. It also means techniques purely intended to increase the sales, patronage and/or good will of a product.
Sales Promo application documents include:
- Integrated Application Form
- Letter of Intent for application of Sales Promo Permit
- List of Participating Products (Excel format)
- Copy of the valid Certificate of Product Registration/Notification (CMDR/CMDN)
- Information sheet and mechanics of the sales promotion
- Layout of Promo materials
- Proof of Payment
- Self-assessment form for Sales Promo permit
New promo permit application will cost between PHP 5,000 and 10,000 while amendments will cost PHP310.
Amendments
Also, instead of submitting a brand-new application for adjusted advertisem*nts, applicants can submit an Amendment application to update their approved marketing content. Documents required for an Amendment application include:
- Integrated Application Form
- Letter of intent specifying the type of amendment
- Copy of previously issued valid promo permit
- Supporting documents for the requested amendment
- Proof of payment
- Self-assessment for Sales Promo Permit
The FDA’s announcement outlining these requirements and the associated review fees can be found here and a local copy has been saved on the Asia Actual website here.
Contact Asia Actual if you have questions about your medical device or IVD device’s advertising requirements in the Philippines.
Philippines Regulatory Support
Contact Us
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SG: +65 3138-4148
EMAIL:Philippines@asiaactual.com
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