The Cost of Breaching RA 9711: Imprisonment, Fines and Administrative Sanctions

1. Key takeaways

Under RA No. 9711, manufacturing, importing, selling, distributing, promoting, advertising or sponsoring a health product without authorisation is punishable by imprisonment of 1 year to 10 years, or a fine of PHP 50,000 to PHP 500,000, or both. Where the offender is a manufacturer, importer or distributor, the penalty rises to imprisonment of 5 years to 10 years plus a fine of PHP 500,000 to PHP 5,000,000. A continuing-violation fine of 1% of the economic value per day or PHP 1,000, whichever is higher, applies on top. Administrative liability can run in parallel with criminal liability.

• Two penalty tiers. The aggravated tier applies specifically to manufacturers, importers and distributors, which is where Chinese manufacturers and their Philippine licence holders sit.
• Prohibited acts go far beyond selling. Promotion, advertising and sponsorship are listed alongside manufacture and distribution.
• Continuing violations accrue daily, at 1% of economic value or PHP 1,000 per day, whichever is higher.
• Administrative action is independent of criminal proceedings and can suspend or cancel the authorisation for up to 1 year.
• Individual officers can be held criminally liable where the offender is a corporation.

2. Legal basis

The penalties sit in RA No. 9711 (the FDA Act of 2009). The table below consolidates the provisions relevant to post-market and authorisation breaches, and notes the grading of the source used for the consolidated reading.

3. Expert insights

Insight 1: the prohibited acts cover far more than selling.

Section 11 of RA No. 9711 lists manufacture, import, export, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising and sponsorship. Of these, promotion, advertising and sponsorship are the three most often overlooked by Chinese manufacturers: advertising a product at a trade fair, or sponsoring an academic session, before the certificate has been issued, is itself a prohibited act. The exposure is easy to create and hard to reverse, because the evidence is public by nature — a booth photograph or a conference programme is sufficient to establish the act.

Insight 2: the aggravated tier applies to manufacturers, importers and distributors, which is exactly the position of Chinese companies.

The penalties run in two tiers: ordinary offenders face 1 to 10 years, while manufacturers, importers and distributors face 5 to 10 years plus PHP 500,000 to PHP 5,000,000. Chinese manufacturers and their Philippine licence holders fall squarely inside the aggravated tier by virtue of their role in the chain. The tier is determined by the function performed rather than by intent, so a company cannot argue its way into the lower band by describing itself differently.

Insight 3: administrative and criminal liability are parallel and independent.

According to the legal commentary, criminal and administrative actions can be brought independently of each other. Even where a criminal case has not been decided, the FDA Director General can still take administrative measures: suspension or cancellation of the authorisation, fines, destruction of products, closure of premises. For a company, administrative measures are often more immediately damaging than criminal proceedings, because they remove the legal basis for trading at once. A defence prepared for a court case does not answer an administrative order that is already in force.

Insight 4: the 1% continuing fine makes delay extremely expensive.

During a continuing violation, the penalty is 1% of the economic value or cost of the violating product per day, or PHP 1,000 per day, whichever is higher. For large import consignments, 1% per day accumulates very quickly. The design intent is clear: to make a strategy of selling first and waiting for the certificate economically unviable. The calculation is based on the value of the product concerned, so the larger the shipment held in violation, the faster the exposure grows.

4. Practical recommendations

• Do not promote, advertise or sponsor before the certificate is issued. These three activities carry the same prohibition as selling, and they leave public evidence.
• Include the licence holder’s compliance status in periodic verification. Once the certificate expires, sales lose their legal basis immediately, even if the product itself is unchanged.
• Stop and remediate as soon as a breach is identified. The continuing-violation fine accrues by the day, so the cost of waiting is measurable and compounding.
• Inform corporate officers of their personal exposure. The chairperson of the board, president, general manager or the person directly responsible may bear criminal liability.
• Maintain a pre-market compliance checklist. Verify certificate status before each shipment is released, and keep the verification record with the shipment file.

5. Verification checklist

• □ List of prohibited acts reviewed against RA No. 9711 Section 11
• □ General penalty understood (1 to 10 years / PHP 50,000 to PHP 500,000)
• □ Aggravated penalty understood (5 to 10 years plus PHP 500,000 to PHP 5,000,000)
• □ Continuing-violation fine understood (1% of economic value per day or PHP 1,000 per day)
• □ Administrative sanctions under Section 29-A reviewed
• □ Internal policy prohibits promotion before certification
• □ Source grading noted: provisions consolidated from a third-tier source and to be checked against the statutory text

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com