Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
DIGEMID
Register your medical device in Peru.
Access the Peruvian market through DIGEMID Health Registration, with a dedicated Authorised Local Representative and five-year validity.
Speak to a specialistThe authority
Direccion General de Medicamentos, Insumos y Drogas
DIGEMID
Regulatory authority
Peru
A body of Peru's Ministry of Health responsible for the sanitary regulation of medicines, medical devices and supplies.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, simplified registration | Bandages, masks, gauze |
| Class II | Moderate risk | Infusion pumps, diagnostic equipment |
| Class III | High risk | Implants, pacemakers, haemodialysis equipment |
Registration process
How we manage your project
- 01
Local Representative2-3 months
Establish a Peruvian Authorised Local Representative
- 02
Classification2 weeks
Determine the class under the supreme decree
- 03
ISO 13485 QMS3-6 months
Certified quality management system
- 04
Technical dossier2-3 months
Prepare the application in Spanish
- 05
DIGEMID submissionvariable
Class I: a few weeks. Class II/III: 6-12 months
- 06
Certificate issuance1-2 weeks
Health Registration number issued
Total timeframeClass I: 1-2 months. Class II/III: 6-12 months
Local representativeAuthorised Local Representative (Health Registration Holder)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | DIGEMID technovigilance and periodic reporting |
| Renewal | 5 years, renewable |
| Required QMS | ISO 13485 |
How HSC helps
Peru in 1 to 12 months, with a dedicated Local Representative.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about DIGEMID
Next step
Ready to start your project in Peru?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist