Philippines Medical Device Advertising: Compliance with Consumer Act and ASC Review

Medical Device Advertising Requirements in the Philippines

Medical device advertising in the Philippines is subject to stringent regulations aimed at consumer protection and is managed through a combination of government law and industry self-regulation. All advertisements must be honest, accurate, and supported by evidence.

📜 Regulatory Oversight

1. Consumer Act of the Philippines (RA 7394): This law forms the basis for advertising regulation, prohibiting false, deceptive, or misleading advertisements.
2. Ad Standards Council (ASC): The industry's self-regulatory body, the ASC, is the primary agency for screening advertising materials. Manufacturers must submit their advertisements to the ASC for review against its Code of Ethics, which covers:
   • Accurate Claims: Claims must be substantiated by specific documents and supporting information.
   • Ethical Content: Prohibition of misleading, indecent, or offensive content.
   • Fair Pricing.

Recommendation: Asia Actual recommends engaging an ASC-accredited advertising agency to facilitate the submission and screening process.

🎫 Sales Promo Permit Requirements

Any advertising or marketing activity that involves rewards or prizes falls under the definition of a "Sales Promotion" and requires a separate Sales Promo Permit from the FDA.

• Definition of Sales Promotion: Techniques intended for broad consumer participation that contain promises of gain (e.g., prizes, cash) as a reward for purchasing a product, winning a contest, or other similar competitions. It also applies to techniques purely intended to increase sales or goodwill.
• Review Time: Sales Promo Permit applications are typically reviewed within 1 month.
• Fees: New permit applications generally cost between PHP 5,000 and PHP 10,000. Amendments cost around PHP 310.

Required Documents for Sales Promo Permit:

1. Integrated Application Form and Letter of Intent.
2. List of Participating Products (must be validly registered).
3. Copy of the valid CMDR/CMDN for the participating devices.
4. Information sheet and mechanics of the promotion.
5. Layout of the promotional materials.
6. Proof of Payment.
7. Self-assessment form.

Amendment Applications

Instead of a brand-new submission, manufacturers can file an Amendment application to update previously approved advertising or promotional content. Required documents include an Integrated Application Form, a Letter of Intent specifying the amendment type, a copy of the previously issued permit, supporting documents for the changes, and proof of payment.