Peru Investigational Devices and Clinical Trials: D.S. N° 021-2017-SA and Exceptional Authorization

Regulatory information verified as of October 29, 2026

1. Key takeaways

Access for investigational devices in Peru is a channel independent of sanitary registration: D.S. N° 021-2017-SA, published on 2017-06-30, provides the framework for clinical trials, with INS approving protocol and results and DIGEMID approving the investigational product; R.M. N° 817-2020/MINSA, published on 2020-10-10, provides the Autorización Sanitaria Excepcional (exceptional sanitary authorization) route for devices in the research stage, adopted against the backdrop of the COVID-19 public health emergency. The exceptional authorization permits research use only and does not constitute a sanitary registration for commercial sale. The operational rule is that the research channel and the commercial channel must never be bridged by shipping, and every movement of an investigational device must remain traceable to its research project number until the device either exits the study or enters an ordinary registration of its own.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: the dual-authority split is a split by object, not a sequence of stamps.

Under the framework of D.S. N° 021-2017-SA, INS approves the protocol and results — the science, ethics and subject protection — while DIGEMID approves the investigational product — the device itself entering the country for the trial. The approval objects differ, and so do the reviewed materials: the former requires the protocol, informed consent and investigator qualifications; the latter requires product technical documentation and quality evidence. Scheduling should place INS before DIGEMID: until the protocol is settled, the intended research use, quantities and sites in the product file cannot be fixed, and reversing the order forces repeated rework at the DIGEMID stage.

Insight 2: the exceptional authorization is a use-limited access, not a simplified registration.

R.M. N° 817-2020/MINSA, published on 2020-10-10, addresses how a device in the research stage obtains lawful status to enter the country and be used in research. Its authorization scope is bound to that use: when the research ends or the conditions of the authorization lapse, the legality ends with it. Reading the exceptional authorization as an early grant of registration and scheduling commercial shipments on that basis is the most serious directional error on this pathway — commercial sale must rest on a Certificado de Registro Sanitario (CRS).

Insight 3: the temporal background of R.M. N° 817-2020/MINSA defines its boundary of application.

That instrument was in force during the COVID-19 public health emergency and is a product of the emergency channel. It demonstrates that the Peruvian system has the institutional capacity to open a channel for research devices in an emergency, and it equally means that its application is tied to the emergency. The arrangements for continuation or conversion after the emergency ends are not found in provisions we have verified and remain a practical estimate; official publications prevail. The long-term channel for device clinical trials remains grounded in D.S. N° 021-2017-SA, published on 2017-06-30.

Insight 4: vigilance duties in the research stage do not sleep because the product is only for research.

R.M. N° 539-2016/MINSA, published on 2016-07-27, requires serious adverse events to be reported within 24 hours and moderate and mild suspected adverse events within 20 calendar days. Subject safety events in research are typical reportable objects, and the research stage is often precisely when the uncertainty of risk is highest. The safety monitoring plan in the protocol must be able to support execution against both deadlines; otherwise, once an event occurs, the absence of a reporting channel will simultaneously damage the research authorization and the later ordinary registration.

Insight 5: research data must flow back into the ordinary registration dossier.

Data generated in the research stage ultimately serve the Clinical Evaluation Report of the ordinary sanitary registration. The protocol should therefore be designed with the correspondence between endpoints and the clinical evidence needs of ordinary registration in mind, avoiding the idle outcome of research conducted but unusable. The review arrangements for research authorizations follow the current procedure text and are not of the same origin as the 22 / 44 / 66 working days clocks of ordinary registration.

4. Practical recommendations

1. Protocol before product: complete the INS materials for protocol and results approval first, then submit the investigational product file to DIGEMID, avoiding repeated revision of the product file as the protocol moves.
2. Write the use boundary into internal rules: tie the import, distribution, use and recovery of investigational devices entirely to the research project number, bar any flow into commercial channels, and tag them separately in internal systems.
3. Organize IVD validation under R.M. N° 694-2020/MINSA (2020-09-03): for IVD research products, prepare validation across the analytical performance dimensions of that guideline (an emergency special document, applicable only to its defined scenarios).
4. Front-load the vigilance channel: identify the in-country reporting responsible person and channel before the study starts, executable against the 24 hours and 20 calendar days deadlines.
5. Design data for migration: align study endpoints and metrics with the clinical evidence needs of the later ordinary registration, so the CER can be drafted directly after the study ends.
6. Verify currency before use: before relying on the R.M. N° 817-2020/MINSA route, verify the state of the public health emergency and the current force of the instrument against official publications.
7. Schedule project duration on a practical estimate basis: where the research stage and the subsequent ordinary registration run in series, total duration has no statutory basis and we estimate 6–12 months.

5. Verification checklist

□ It has been confirmed that investigational devices follow the exceptional sanitary authorization channel and are not commercially sold

□ The division and sequence of INS (protocol and results) and DIGEMID (investigational product) have been defined under D.S. N° 021-2017-SA

□ The current force and emergency background of R.M. N° 817-2020/MINSA (2020-10-10) have been verified

□ It has been confirmed that IVD validation in research follows R.M. N° 694-2020/MINSA (2020-09-03), where applicable

□ An import — use — recovery closed-loop identification for investigational devices has been established, isolated from commercial channels

□ The vigilance reporting responsible person and channel have been designated (24 hours / 20 calendar days)

□ Study endpoints have been aligned with the clinical evidence needs of the later ordinary registration

□ Schedule has been reserved for the subsequent Class III/IV ordinary registration on the 66 working days clock

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration support in Peru for manufacturers, importers and authorized representatives, including clinical trial authorizations and exceptional sanitary authorization management. Contact: info@grzanglobal.com