Peru Instructions for Use: Instrucciones de Uso Content Requirements for Registration

Regulatory information verified as of October 29, 2026

1. Key takeaways

The instructions for use, the Instrucciones de Uso or IFU, are a mandatory component of the registration dossier in Peru: item 7 of Class I and item 6 of the IVD pathway both explicitly require a Spanish-language version. The content list is set by the instructions for use chapter of D.S. N° 016-2011-SA, published on 2011-07-27, with additional provisions for special situations such as sterility indication, validity claims, irradiation, accuracy, and implants, specific article numbers pending verification, subject to the official publication. An IFU is not an expanded label. It answers a different question: how a user safely completes a task on the basis of this document alone. Files that treat the IFU as marketing copy with operating steps appended fail because the identification, claims, and risk sections that frame those steps are missing or buried.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The content list follows a cognitive path of identification first, then claims, then risks.

The contents listed by the regulation run in this order: the device name and package contents, the sterility indication and sterilization method, the intended use, single use, storage transport and handling conditions, and warnings and precautions. The first 2 items let the user confirm what has been received; the middle items set the boundaries of use; the last items deliver the risk control measures. This ordering means an IFU cannot be written as a product brochure with an appendix: jumping directly to operating steps while omitting the identification and claims sections leaves the reviewer unable to determine whether the risks were bounded by the preceding conditions at all.

Insight 2: The trigger for each additional element is a device function, and the burden of justifying an omission falls on the applicant.

The additional provisions cover: the statement of Essential Principles already met and possible side effects, identification of combined or connected use, the nature and frequency of installation, calibration, and maintenance, implant-related risks, mutual interference risks, handling of a damaged sterile barrier, cleaning disinfection reconditioning and sterilization procedures with cycle limits for reusable devices, processing required to sterilize the device before use, additional processing before use, the nature type intensity and distribution of radiation where medical radiation is emitted, information on operating changes for devices intended for healthcare professionals and on preparations containing medicinal substances, and the accuracy of measuring devices. None of these applies to every device; the criterion is whether the device has the function. Having the function without writing the section is a missing item; not having the function allows an explicit not applicable statement with a reason.

Insight 3: The IFU, the label, and the technical report must hold three-level consistency of terminology and values.

For the same device, the single-use marking on the label, the prohibition of reprocessing procedures in the IFU, and the materials and design life described in the technical report must point to one conclusion. The high-frequency inconsistency points in practice are accuracy for measuring devices and reprocessing cycles for reusable devices: the label and the technical report each carry one value, the IFU supplies a third, and the file comes back with observations demanding alignment across all three.

Insight 4: The language obligation is a condition of market access, not a matter of delivery format.

A missing Spanish IFU is treated as that item not submitted. In translation, terminology consistency must share the same glossary as the item 6 proposed label; otherwise a single registration ends up carrying two parallel vocabularies for the same parameters.

4. Practical recommendations

1. Write against the content list as the skeleton, marking every non-applicable clause as not applicable with its reason.
2. For sterile devices, state the sterility indication and the sterilization method, consistent with the validated process of item 9.
3. Combine the statement of Essential Principles already met and possible side effects into a dedicated section, not scattered through the operating steps.
4. For measuring devices, state the accuracy figures and the conditions of their determination.
5. For reusable devices, state the cleaning, disinfection, reconditioning, and sterilization procedures and the cycle limits.
6. For devices emitting medical radiation, describe the nature, type, intensity, and distribution of the radiation.
7. Maintain a three-level terminology and value comparison table across label, IFU, and technical report, unified before submission.

5. Verification checklist

□ The IFU is in Spanish and shares one terminology glossary with the label

□ Name and package contents, sterility indication and sterilization method, intended use, and single use are included

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

□ The statement of Essential Principles already met and possible side effects is included

□ Combined or connected use, installation calibration maintenance nature and frequency, implant risks, and mutual interference are stated according to function

□ Reusable devices state the cleaning disinfection reconditioning and sterilization procedures and cycle limits

□ Radiation-emitting and measuring devices state the corresponding content required by the additional provisions

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 Spanish IFU preparation, content clause review, and terminology alignment across the dossier. For inquiries, contact info@grzanglobal.com.