DIGEMID do Peru: Prazos de Registro e Taxas

How long does DIGEMID take? Peru's health ministry published new procedure rules in July 2026, with review limits and fees for every device class. And silence does not mean yes. DIGEMID registers devices by risk class, for five years. Its review limit is 22 working days for Class I, 44 for Class II, and 66 for Classes III and IV. Fees: S/ 1,438.70 to S/ 2,176.40. IVDs follow their own procedure: 30 working days. And note what silence means. If that limit passes without an answer, the application is not approved. The procedure carries negative administrative silence, so you can file a reconsideration or an appeal. One more gate: importers need a sanitary operating authorization as a droguería or laboratory. A droguería that imports devices also needs Good Storage Practices certification. Start with three things. One: confirm the device class under Peru's rules. Two: choose a licensed importer with storage certification. Three: track the review limit, and know your appeal options. Never assume silence means yes. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.