3. Plan for DIGEMID registration

Surgical and dental instruments sold in Peru need a sanitary registration (registro sanitario) from DIGEMID, the Ministry of Health’s authority for medicines and medical devices, under Ley 29459 and its regulations.

• Local holder: a foreign manufacturer cannot hold the registration itself. A Peruvian pharmaceutical establishment with the right authorization, usually your importer or distributor, holds it.
• Risk classes: devices are classified from Class I (low risk) to Class IV (high risk). Reusable surgical and dental hand instruments generally sit in Class I, which carries the lightest dossier.
• Dossier: DIGEMID’s requirements are broadly similar to those in Colombia and Argentina. Expect a technical file with product description, materials, labeling and instructions in Spanish, plus quality and free-sale certificates.
• Public search: DIGEMID publishes a searchable database of registered devices, which is useful for checking what competitors have registered.

What to ask your supplier: ISO 13485 and CE certificates, a Certificate of Free Sale, the proposed risk class per item, material specifications, and Spanish-language labels and reprocessing instructions. Grouping instruments into logical families early keeps the number of filings down.