Peru Customs Import: Registration Status and Clearance Requirements

Regulatory information verified as of October 29, 2026

1. Key takeaways

The substantive precondition for customs clearance of imports into Peru is that the sanitary registration (Registro Sanitario, RS) corresponding to the goods is in valid status and that the importing entity is a qualified pharmaceutical establishment (Establecimiento Farmacéutico). An expired registration, a mismatch between the importing entity and the registration record, or a suspended facility license all convert into return or detention risk at the clearance stage. The verifiable procedural basis comes from D.S. N° 016-2011-SA (published on 2011-07-27) and D.S. N° 011-2026-SA (Nuevo Texto Único de Procedimientos Administrativos (TUPA) del MINSA, published on 2026-07-21). The specific documentary checklists used at clearance are a practical estimate. Because clearance officials act on registry status rather than on representations of the parties, every claim about the registration must be backed by a live query of the official database before the goods are shipped.

The GRZAN principle is that registration status verification must be moved forward and completed before loading; the customs clearance site is not a remediation stage.

2. Legal basis

Regulatory information verified as of October 29, 2026. Registry data are statistics derived from the official DIGEMID registry (Category C, extracted on 2025-02-14).

3. Expert insights

Insight one: clearance verifies registered status, not prior approval. The validity period of a sanitary registration is 5 years, counted from the date of grant, and it is renewable. Mechanically, the clearance stage reads the current status in the registry, not the paper certificate. A sanitary registration certificate (Certificado de Registro Sanitario, CRS) that was once issued does not constitute a basis for release if the corresponding registry entry has expired, been suspended, or been revoked. This is precisely why GRZAN makes a query of the DIGEMID registry a mandatory pre-loading action.

Insight two: customs warehouses are covered by the storage regulation, so even a detention period can generate compliance liability. The scope of the BPA manual of R.M. N° 132-2015/MINSA (published on 2015-03-02) expressly includes Almacenes Aduaneros (customs warehouses). The mechanical meaning is that while goods are detained in a customs warehouse over documentary issues, storage conditions remain regulated; temperature deviations affecting cold chain devices during a prolonged detention become a new point of dispute at subsequent release, not merely a warehousing cost.

Insight three: the scale of the registry determines the accuracy required of verification. According to statistics derived from the official DIGEMID registry (Category C data, extracted on 2025-02-14), the registry contains 33,109 registration records, of which 28,819 are valid registrations, from 6,316 manufacturers and 1,688 registration holders, covering 68 countries of origin. The proportion of valid registrations among total records shows that a considerable number of records are in non-valid status; judging releasability merely by the existence of a record is insufficient, and the status field and validity dates must be checked.

Insight four: the review clock and the arrival schedule must be aligned in opposite directions. Under the 2026 new TUPA, Class I is 22 working days, Class II is 44 working days, Classes III/IV are 66 working days, and IVD is 30 working days (Category C data). If goods are shipped against an optimistic clock while the registration is still under review, the registry will not be effective at arrival and the risk falls on the applicant. The remedy logic of this procedure is negative administrative silence (Silencio Administrativo Negativo): expiry of the period without a response does not constitute approval, and goods must not be presumed releasable on that basis.

4. Practical recommendations

1. Before loading, check the registration number, holder name, and validity fields shipment by shipment in the DIGEMID registry, confirming the status is valid.
2. Verify that the importing entity holds a Droguería (wholesale distributor) or Laboratorio license and a sanitary operating authorization that are currently valid, and that it matches the holder on the registration record.
3. Schedule vessel arrivals on conservative values of the TUPA working day clocks, avoiding goods waiting for certificates caused by review overruns.
4. For cold chain goods, confirm during the document preparation stage the storage conditions of the customs warehouse and the handover method for temperature records.
5. If detention occurs, launch documentary correction and storage condition monitoring in parallel, preventing the release dispute from extending from documents into product quality.
6. Treat expiry without a response under negative administrative silence, proceeding to reconsideración (Reconsideración) or appeal (Apelación), and do not schedule shipments.

5. Verification checklist

□ The registration number and status have been checked in the DIGEMID registry as valid.

□ The 5-year validity period of the sanitary registration has been checked as not expired.

□ The receiving entity has been verified as identical to the holder on the registration record.

□ The importing entity has been confirmed to hold a facility license and a sanitary operating authorization.

□ The customs warehouse has been confirmed as covered by the R.M. N° 132-2015/MINSA storage regulation, with temperature handover implemented.

□ Shipping has been scheduled in reverse against the TUPA clocks (22 / 44 / 66 working days, IVD 30 working days).

□ It has been confirmed that negative administrative silence has not been treated as approval.

□ Regulatory information verified as of October 29, 2026.

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Peru for manufacturers, importers, and authorized representatives. For inquiries, contact info@grzanglobal.com.

*GRZAN Regulatory Affairs Team*