Peru Silencio Administrativo Negativo: Deadlines and Remedies in Device Registration

Regulatory information verified as of October 29, 2026

1. Key takeaways

When the statutory period expires without a reply in the Peruvian device registration procedure, the legal meaning is denial, not approval — the procedure operates under negative administrative silence (Silencio Administrativo Negativo). The remedy runs along the administrative procedure framework of Ley N° 27444, published on 2001-04-11, through reconsideración and apelación, where reconsideración must be filed within 15 working days before the Ejecutivo Director of the Directorate of Medical Devices and Sanitary Products (per the TUPA; specific article numbers pending verification; official publications prevail). Any production or shipping plan built on the assumption of automatic approval at expiry rests on a false premise. Commercial release must wait for an issued sanitary registration certificate, and the expiry of the review clock should instead trigger a documented remedy sequence, planned before the clock even starts.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: negative silence is an institutional design that translates inaction into an administrative act.

If an administrative procedure sets a reply deadline without a legal consequence at expiry, applications hang indefinitely: the applicant receives neither approval nor any actionable object to challenge. Negative administrative silence exists to close exactly this gap. When the period expires without a decision, the law deems a negative decision to have been issued, which gives the applicant a contestable administrative act — the necessary legal object for any remedy. The mechanical consequence is direct: the burden of initiating the remedy sits entirely with the applicant, and the authority has no duty to proactively announce that silence has operated. A company that merely watches a portal status without maintaining a deadline ledger will reach the moment silence takes effect having started nothing, and the 15 working days window will already be burning.

Insight 2: the drafters placed the risk on the side of unreviewed products reaching the market.

Compared with implied approval, the legislative choice of negative silence signals a clear priority: it is preferable that a compliant application be delayed than that a device without substantive review acquire market status. This orientation fixes two things. First, the compliance anchor for any import or commercial sale can only be an issued Certificado de Registro Sanitario (CRS). Second, an applicant cannot claim to have been authorized because the authority missed its deadline; the overrun is a performance problem on the authority side and is not a source of rights for the applicant. The remedy for an overrun is the remedy procedure, not self-help through shipping. Companies that internalize this distinction avoid the most severe enforcement exposure available in this system.

Insight 3: reconsideración and apelación are tiered instruments, and choosing the wrong tier wastes the remedy budget.

Reconsideración is filed before the authority that issued the decision, which reviews it anew on the basis of fresh arguments; apelación is filed before the superior authority, which examines the legality and appropriateness of the lower decision. Under the TUPA, the reconsideración period is 15 working days, filed before the Ejecutivo Director of the Directorate of Medical Devices and Sanitary Products (specific article numbers pending verification; official publications prevail). The practical dividing line is the nature of the dispute: where the dispute stems from incomplete corrective documentation, supplementing the materials within reconsideración is the more direct route; where the dispute stems from disagreement over the application of technical requirements, resubmitting the same package to the same level only reproduces the same conclusion, and the effort should instead go into a higher-tier legal and technical argument.

Insight 4: the silence period and the deficiency-response period are independent timelines that cannot be converted into each other.

The review clock (22 / 44 / 66 working days) expiring without a reply marks the start of negative silence; the 30 working days after an Observaciones letter is the applicant’s own response window, and failure to respond within it constitutes grounds for denial. The two bind different parties: the first constrains the authority, the second constrains the applicant. Treating an unfinished response as a reason why the clock has not yet started misreads whose deadline it is — the clock binds the authority regardless of whether the applicant has finished correcting, and the response window runs from the deficiency letter regardless of the clock.

4. Practical recommendations

1. Maintain a clock ledger: for each file under review, record the submission date, the risk-level clock (22 / 44 / 66 working days, IVD 30), the expiry date and the remaining days, and pre-position a reconsideración plan 15 working days before expiry.
2. Evidence the expiry immediately: when the period lapses without a reply, fix the fact of expiry on the same day using the acceptance receipt, the submission confirmation and screenshots of the system status, as the evidentiary basis for the operation of silence and for any subsequent remedy.
3. Match the remedy to the argument: for documentation-gap disputes, file reconsideración and supplement the materials in parallel; for disputes over technical interpretation, prepare a two-layer legal and technical argument and avoid repeating the same reasoning at the same level.
4. Do not file a duplicate application: covering an old application with a new one resets the review clock and may create duplicate procedural records for the same product, which in fact weakens the later evidentiary position.
5. Gate shipping and customs clearance on the certificate: arrange no commercial shipment before the sanitary registration certificate is issued; verify registration status against current data on the official DIGEMID platform.
6. Build the silence risk into the project plan: for Class III/IV projects, reserve at least one remedy cycle beyond the 66 working days clock, and estimate total duration on a practical estimate basis at 4–8 months.

5. Verification checklist

□ It has been confirmed that the procedure operates under negative administrative silence (Silencio Administrativo Negativo), not implied approval

□ Review clocks have been registered: Class I 22, Class II 44, Class III/IV 66, IVD 30 working days

□ The reconsideración period of 15 working days and its addressee (Ejecutivo Director of the Directorate of Medical Devices and Sanitary Products) have been registered

□ A retention mechanism for submission acceptance receipts and expiry evidence has been established

□ The distinct ownership of the 30 working days deficiency-response window and the review clock has been distinguished

□ It has been confirmed that commercial shipping and customs clearance are gated on issuance of the sanitary registration certificate

□ A remedy cycle has been reserved in the project plan

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration support in Peru for manufacturers, importers and authorized representatives, including remedy management under negative administrative silence. Contact: info@grzanglobal.com