Chapter 1 Peruvian DIGEMID Administration Information Abstract

1. Administration and Abstract

The regulatory authority for medical devices in Peru is the General Directorate of Medicines, Supplies and Drugs (Direccion General de Medicamentos, Insumos y Drogas, DIGEMID). Mainly responsible for the registration supervision and management of medical devices, document review, technical assessment, safety testing, quality management system audit, medical device sales license approval, etc.

2. Administrative Regulation

Ley N° 29459 and its amendments Decreto Supremo N° 020-2024-SA

Decreto Supremo N° 016-2011-SA and its amendments Decreto Supremo N° 010-2023-SA 

3. Risk Level Classification of Medical Device and IVD Products

According to the regulations of the Peruvian General Directorate of Medicines, Supplies and Drugs, medical devices are classified into Class I, Class II, Class III, and Class IV:

4. Entry Requirements

Both MD and IVD require ISO13485 certificates to demonstrate the quality system of the actual manufacturing site.

For manufacturers located outside Peru, it is also necessary to appoint an authorized representative as a Peruvian Registered Holder (PRH);

The applicant needs to prepare detailed product technical specifications, manufacturing processes, material used and other information so that the audit body can assess the quality and safety of the product.

Registration Documents:

5. Registration Language

Spanish.

Chapter 2 Registration Flow、Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Chapter 3 FAQ

Q: What to deal with that if a medical device or IVD product changes after obtaining a Peruvian registration certificate?

A: Classification of changes to medicines and biological products subject to conditional health registration in accordance with article 36 of the Regulations on Registration, Control and Health Supervision of Medicines, Medical Devices and Medical Devices approved by Supreme Decree No. 016-2011-SA (as amended).

Minor changes only need to notify to the National Health Authority, which does not need to issue any announcements. The holder of a medical device certificate shall be able to implement the corresponding change within six months from the day of notification.

For significant changes, medical device certificate holders should file a change application with the National Administration for Drugs, Medical Devices and Medical Equipment (ANM), which has a maximum of thirty natural days to resolve the application. The administration gives up to six months to adjust the changes to the application.

Q: How long is the validity period after the registration of medical devices in Peru?

A: Five years.