Peru Medical Device Registration: Eligible Applicants, Drogueria and Laboratorio Qualification

Regulatory information verified as of October 29, 2026

1. Key takeaways

In Peru, the only entities that may file an application for a medical device Registro Sanitario (RS) are Establecimientos Farmacéuticos (pharmaceutical establishments) that have been legally incorporated and hold a Droguería (wholesale distribution) or Laboratorio (laboratory) license. Foreign manufacturers cannot submit applications directly in their own name to the national product authority (Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, ANM), exercised through the General Directorate of Medicines, Supplies and Drugs (DIGEMID). Instead, they must route the filing through a domestically licensed entity that acts as the registration holder (Titular del Registro Sanitario / Peru Registration Holder, PRH). Locally manufactured products destined exclusively for export are exempt from the registration obligation; the specific article number of this exemption is pending verification, and the official publication governs. In practical terms, this means that the choice of holding entity is a gating decision in every Peru market-entry project: it comes before dossier preparation, before fee planning, and before submission scheduling, because without a qualified applicant the file simply cannot be lodged.

When GRZAN accepts an engagement from a foreign manufacturer, the first judgment it makes is to decompose the question of whether a product can be registered into two independent issues: whether the entity is qualified, and whether the dossier is complete. If the first issue is not resolved, no amount of dossier completeness will move the application into substantive review.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight one: applicant qualification and facility licensing sit on the same chain; they are not two parallel conditions. The registration logic of D.S. N° 016-2011-SA is not a product permit in isolation but a binding structure of entity qualification plus product technical evidence. The Droguería or Laboratorio license is granted under D.S. N° 014-2011-SA, while the registration application is governed by D.S. N° 016-2011-SA; the two procedures are separate, yet they share the same entity identifier. The mechanical consequence is that once a facility license is suspended or revoked, the sanitary registrations registered under it lose their enforceable licensing basis rather than continuing to exist independently. This is the regulatory root of treating the PRH as a long-term compliance asset rather than a one-off rental arrangement.

Insight two: the functional divide between Droguería and Laboratorio defines the boundary of what can be declared. R.D. N° 033-2017-DIGEMID-DG-MINSA sets out the list of devices that Droguerías and laboratories may sell directly to users; conversely, products and sales channels outside the list are subject to stricter distribution constraints. A Laboratorio also carries manufacturing functions, and in scenarios involving segmented or contract manufacturing, Sección 1.5 of D.S. N° 016-2011-SA provides the relevant rule entry point. GRZAN treats the question of which type of entity should hold the license as a product-portfolio question, not an administrative formality.

Insight three: the export exemption is an exemption from the registration obligation, not from quality obligations. The exemption for locally manufactured products destined exclusively for export reflects the mechanism that products not placed in domestic commerce do not enter registration review; its specific article number is pending verification, and the official publication governs. What it exempts is the obligation to file with DIGEMID and obtain a sanitary registration certificate. It does not exempt the manufacturer from good manufacturing practice requirements (Buenas Prácticas de Manufactura, BPM, i.e. GMP) or from the market-access requirements of the destination country of the exports.

Insight four: registry data reveal the concentration of license holding. 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 number of holders is far lower than the number of manufacturers, which shows that most foreign manufacturers do not build their own licensed entity in Peru but instead place their market access on a small number of qualified pharmaceutical establishments.

4. Practical recommendations

1. Before initiating a project, confirm the license category and current status of the intended holding entity, obtain its sanitary operating authorization and facility license documents, and verify that its business scope covers the device to be registered.
2. Compare the device to be registered against the R.D. N° 033-2017-DIGEMID-DG-MINSA list to determine whether the direct-to-user Droguería pathway or a restricted channel pathway applies.
3. If a foreign manufacturer plans to establish its own holding entity, the facility set-up and authorization under D.S. N° 014-2011-SA must be completed first, with the registration application scheduled only after the authorization is granted.
4. Where contract manufacturing or segmented manufacturing is involved, prepare the allocation of responsibilities between the manufacturer and the license holder in accordance with Sección 1.5 of D.S. N° 016-2011-SA.
5. For export-only projects, record the basis of the exemption assessment separately in internal project documents, noting that the article number is subject to the official publication.

5. Verification checklist

□ The license category of the intended holding entity has been checked and is either a Droguería or a Laboratorio.

□ The facility license has been checked as currently valid, with no suspension or revocation records.

□ The channel attributes of the device to be registered have been compared against the R.D. N° 033-2017-DIGEMID-DG-MINSA list.

□ Existing registration records and their status under the entity have been verified in the DIGEMID registry.

□ The article number of the export exemption has been confirmed through official channels (currently marked as subject to the official publication).

□ 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*