Peru Medical Device Advertising and Promotion Restrictions: Red Lines and Consistency Duties

Regulatory information verified as of October 29, 2026

1. Key takeaways

Peru draws two hard red lines for medical device advertising and promotion: distribution of samples directly to patients or the public within healthcare facilities is prohibited, and physician-representative activities must not take the form of persuasive engagement directed at patients; for devices sold without a prescription, promotional material must state the principal warnings and precautions corresponding to the approved registration content, and print-media advertising must additionally state the technical information. The essence of these rules is that ordinary consumers do not bear the risk of self-diagnosis, so promotional content cannot exceed the approved scope of the registration. The framework derives from the Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, namely Ley N° 29459 (published on 2009-11-26), and the Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, namely D.S. N° 016-2011-SA (published on 2011-07-27), with specific article numbers pending verification; the official publication prevails. Regulatory information verified as of October 29, 2026.

2. Legal basis

3. Expert insights

Insight 1 | What is prohibited is persuasion directed at patients, not representative activities as a whole

Within the healthcare-facility setting, the red line falls on sample distribution to patients or the public and on persuasive activities aimed at them. Mechanically, the legislator seeks to cut the path of bypassing professional judgment and influencing patient choice directly in the clinical setting; communication with medical professionals focused on the technical characteristics of the product is not within the prohibition. The same brochure and the same representative produce entirely different legal consequences depending on whether the audience is a physician or a patient — which is why marketing teams must record the activity type, the audience identity and the nature of the venue in the activity approval form in advance.

Insight 2 | Warnings and precautions must correspond to the registration — an extension of the content-consistency duty

Promotion for devices sold without a prescription must state the principal warnings and precautions because, outside a professional setting, that text is the only carrier of risk information. The benchmark is the boundary of the approved registration content: contraindications and precautions written in the Instructions for Use (Instrucciones de Uso) must appear in the promotional material as they are, without dilution or deletion by marketing language. We maintain a four-way cross-reference table of registration dossier, label, instructions for use and promotional material; any claim of intended use appearing in one place but not in the others is a rework item.

Insight 3 | Stating technical information in print media is about verifiability

Print media reaches a wide audience and persists over time; requiring the statement of technical information (such as product name, registration details and technical parameters) allows inspectors, professionals and consumers to trace back immediately to the official registered content. The requirement effectively gives every advertisement an anchor that can be aligned: slogans can be designed, technical information cannot be blurred. In practice we require clients to reserve a statutory-elements block in the layout, and a visual-design rationale or a QR code substitution does not justify compressing or replacing it.

4. Practical recommendations

1. Maintain a four-way cross-reference table of promotional materials: registration dossier, label (Rotulado), instructions for use and advertising copy, checking intended use and restrictions item by item.
2. For every over-the-counter device material, fix a block of principal warnings and precautions, with wording taken verbatim from the approved instructions for use and no editing.
3. Reserve a statutory-elements block in print-media copy stating the product name, registration details and technical information, without deletion for layout design reasons.
4. Add three mandatory fields to the representative-activity approval form: the venue, the participants and whether any patient-facing element exists; any plan containing a patient-facing element is rejected outright.
5. Strictly prohibit direct distribution of samples to patients or the public inside healthcare facilities; the movement of trial packs and demonstration units requires a written ledger and return records.
6. Link promotional complaints with tecnovigilance: incidents caused by misleading use are reported within the deadlines of R.M. N° 539-2016/MINSA (2016-07-27).

5. Verification checklist

□ The intended use of the promotional materials has been confirmed not to exceed the boundary of the approved registration (regulatory information verified as of October 29, 2026).

□ Over-the-counter device materials state the principal warnings and precautions, with wording identical to the approved instructions for use.

□ Print-media copy contains a statutory-elements block stating the technical information.

□ It has been confirmed that no patient-facing sample distribution or persuasive activity takes place within healthcare facilities.

□ Consistency has been checked against the minimum 5 items of simplified labeling (name or code, batch number, expiry date, storage and transport conditions, registration number).

□ Communication concerning prescription or professional-use devices is restricted to medical professionals.

□ The provisions are cited as Ley N° 29459 (2009-11-26) and D.S. N° 016-2011-SA (2011-07-27), with specific article numbers pending verification; the official publication prevails.

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration and post-market compliance support in Peru for manufacturers, importers and authorized representatives. For assistance, contact info@grzanglobal.com.