Peru Class I Technical Dossier: The Seven Required Items Under D.S. N° 016-2011-SA

Regulatory information verified as of October 29, 2026

1. Key takeaways

The Class I dossier in Peru is a streamlined submission, not an exemption from documentation. Article 124 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, enumerates exactly 7 items of documentation, and a single missing item is enough to trigger observations, the deficiency findings that block approval. Among these seven items, item 4, the technical report, and item 7, the instructions for use in Spanish, known as Instrucciones de Uso or IFU, are the two documents most frequently cited in rejection decisions. Manufacturers who treat Class I as a low-threshold category effectively defer the two most error-prone documents to the last stage of preparation. The consequence is predictable: the review clock runs, observations arrive, and the applicant enters the deficiency correction cycle with a file that was never complete in the first place. A Class I registration is won by assembling a compact but internally consistent dossier, not by submitting less.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The seven items form a three-stage chain of legality, process evidence, and product description, not a flat checklist.

Item 1, the sworn declaration application, and item 2, the Certificate of Free Sale, the Certificado de Libre Venta or CFS, together establish who is applying and whether the product circulates lawfully in its country of origin. Item 3, the quality evidence, whether a Good Manufacturing Practice certificate, a CE mark, or an ISO 13485 certificate, addresses whether the manufacturing process is under control. Items 4 through 7 describe what the product actually is and how it is used. The mechanism matters: the three stages support one another and no stage can substitute for another. However complete the CFS may be, it cannot prove that manufacturing is controlled; however complete the quality certificate may be, it cannot prove that the labeling is written correctly. Reviewers read the dossier as a chain, and a chain is judged at its weakest link.

Insight 2: The five contents of the item 4 technical report form a lifecycle chain, and one omission propagates backward into three rework loops.

Under Article 124, the Class I technical report must contain descriptive specifications, intended use, warnings, storage and transport conditions, and presentation form, five categories of content in total. They are not parallel boxes but consecutive slices of one product lifecycle: the descriptive specifications define the boundary of intended use, the intended use limits the scope of warnings, and the storage and transport conditions are derived from the presentation form and material properties. A technical report that omits storage and transport conditions will typically surface as a missing storage marking on the item 6 proposed label and as missing operating restrictions in the item 7 Spanish IFU. One omission at the source lands on three documents and is returned three separate times.

Insight 3: Item 5, the technical study and the manufacturer analytical testing, is often mistaken for a third-party laboratory report.

The critical element of this item is the manufacturer own analytical testing, meaning the release controls the manufacturer performs and the basis on which those controls are established, not a passing conclusion issued by an external laboratory. The review logic seeks to determine whether the manufacturer is capable of consistently producing conforming product. An external test report proves only that one sample passed on one occasion; it cannot answer the question of batch-to-batch stability. GRZAN requires in practice that this item state the test parameters, the methodological basis, and the acceptance limits, and that the document be version-aligned with the technical report.

Insight 4: The language obligation of item 7 is a rigid threshold.

The proposed label and the IFU must be in Spanish. This is not a question of translation polish but a condition of the registration itself: if the Spanish documents are missing, the item is treated as not submitted at all.

4. Practical recommendations

1. Build a document ledger against the 7 items, recording the version number and issue date of each document, and run a consistency comparison before submission.
2. Turn the 5 categories of content of the item 4 technical report into a fixed section template, and forbid leaving sections blank or writing not applicable without a stated reason.
3. Ensure the CFS covers the models proposed for registration and remains valid at the time of submission.
4. Align the certificate holder and site address of the item 3 quality evidence with the declared manufacturer information.
5. Draft the item 6 label artwork from the same terminology glossary as the item 7 IFU, so that no parameter carries two different names.
6. Schedule backward from the 22 working days review clock and reserve capacity for the 30 working days deficiency correction window.

5. Verification checklist

□ All 7 items required by Article 124 of D.S. N° 016-2011-SA are complete, with no missing item

□ Item 1, the sworn declaration, has been signed by a subject with standing to apply

□ Item 2, the CFS, covers the declared models and is within its validity period

□ The holder and address of the item 3 quality evidence are consistent with the manufacturer information

□ Item 4, the technical report, contains all 5 categories: descriptive specifications, intended use, warnings, storage and transport, and presentation form

□ Item 5 includes the method and acceptance limits of the manufacturer analytical testing

□ Item 6, the label artwork, and item 7, the Spanish IFU, use consistent terminology

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 dossier assembly, labeling and IFU review, and deficiency response. For inquiries about Class I registration under D.S. N° 016-2011-SA, contact info@grzanglobal.com.