Peru’s healthcare market is growing, with public hospitals, social security (EsSalud) and a rising private sector. Medical devices are regulated by DIGEMID.
This is a general overview, not regulatory advice.
Registration
Devices need a sanitary registration with DIGEMID, held by a local company. Requirements depend on the risk class.
Typical needs
- Certificate of free sale and quality certificates
- Technical documents
- Spanish labelling
Opportunities
- Public tenders for hospitals
- Private clinics in Lima and other cities
- Dental and veterinary markets
Peru with Tata Surgical
We support Peruvian distributors with documents and private label. Contact us.
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