Peru Medical Device Labeling: Mandatory Rotulado Elements and the Small Packaging Rule

Regulatory information verified as of October 29, 2026

1. Key takeaways

The labeling obligation in Peru, known as Rotulado, is set by the packaging and labeling chapter of D.S. N° 016-2011-SA, the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products, published on 2011-07-27. The mandatory elements cover the product name, package contents, the word ESTERIL and the sterilization method where applicable, the batch number, the expiry date or manufacturing date, the intended use, the declaration of medicinal or biological substances contained, single use, storage transport and handling conditions, warnings and precautions, the manufacturer name and country, the country of origin, the registration holder name, address and tax identification, and the sanitary registration number. Beyond these elements, the regulation imposes mandatory statements for three production models, and provides that where the primary packaging is too small a reduced set of at least 5 elements applies, with specific article numbers pending verification, subject to the official publication.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The mandatory elements form a traceability chain in which every element answers a later action.

The name and the package contents answer what this is. The batch number together with the expiry date or manufacturing date forms the minimum information set for recall traceability. The manufacturer name and country and the country of origin answer who made it and where it came from; the two can differ where production processing is geographically split, which is why they are listed separately. The registration holder name, address, and tax identification fix the administratively responsible subject, and the sanitary registration number ties the physical product to the Certificado de Registro Sanitario, the CRS. If any element is missing, a state arises in the market where the product can be sold but cannot be traced back, and this is precisely the mechanical reason labeling rules are strictly enforced.

Insight 2: The mandatory statements for the production models are, in substance, information disclosures for four supply chain shapes.

Production abroad with packaging and finishing in Peru, import of finished products produced abroad, reconditioning known as reacondicionamiento, and manufacture to the order of a third party: the common feature of these forms is that a separation has occurred between the actual maker of the product and the subject responsible for placing it on the market. If the label names only the manufacturer, neither consumers nor the regulator can identify the true relationship. The regulation therefore does not prescribe a rigid wording formula but requires the separation to be disclosed honestly on the label. In operation, the statement content must match the item 1 sworn declaration and the actual contractual relationships, otherwise it constitutes a deviation from the technical file.

Insight 3: ESTERIL is not a decorative word; it binds the sterilization method to the validation report in the technical file.

A label bearing the word ESTERIL must also state the sterilization method. The pairing is linked at review: once the method is stated, a corresponding process must be findable in the item 9 sterilization process validation report of the sterile product. Claiming sterility while stating only the first and not the method, or stating a method that cannot be matched to the validation report, constitutes a nonconformity in either direction. This is also why the item 6 proposed label of a Class I dossier must be prepared in step with the item 7 instructions for use in Spanish, the Instrucciones de Uso or IFU.

Insight 4: The minimum 5 elements rule for small primary packaging is the legal definition of the minimum traceable set.

Where the primary packaging is too small to carry all elements, the regulation permits a reduction to at least 5 elements: name or code, batch number, expiry date, storage and transport conditions, and the sanitary registration number, adding ESTERIL where applicable, with specific article numbers pending verification, subject to the official publication. The selection logic is clear: all traceability elements and the core storage information are retained, while explanatory content is yielded to the secondary packaging and the IFU. The common error is reading the rule as any convenient handful of items, which drops one of the traceability elements and defeats the purpose.

4. Practical recommendations

1. Build an element-by-element checklist mapping every mandatory element to the artwork before finalizing it.
2. For products marked ESTERIL, state the sterilization method at the same time and keep it consistent with the validated process.
3. Select the production model statements according to the actual supply chain shape, keeping them consistent with the contractual relationships in the technical file.
4. State the manufacturer country and the country of origin on separate lines, and never merge them when they differ.
5. Keep the registration holder information identical to its current qualification documents, with the tax identification complete.
6. Where the small primary packaging reduction is used, ensure the 5 traceability and storage elements are complete and carry the remaining elements on the secondary packaging.

5. Verification checklist

□ Mandatory elements checked one by one: name, package contents, ESTERIL and sterilization method, batch number, expiry date or manufacturing date

□ Intended use, declaration of medicinal or biological substances, and single use are stated

□ Storage transport and handling conditions, warnings and precautions are stated

□ Manufacturer name and country and country of origin are stated on separate lines

□ Registration holder name, address, tax identification, and sanitary registration number are stated

□ The production model statement corresponding to the supply chain shape is applied

□ The reduced primary packaging version retains at least the 5 elements

Regulatory information verified as of October 29, 2026.

*GRZAN Regulatory Team*

GRZAN provides medical device registration support in Peru for manufacturers, importers, and authorized representatives, covering labeling review against the Rotulado rules, production model statements, and deficiency response. For inquiries, contact info@grzanglobal.com.