Peru

1. Authorities

In Peru, the agency responsible for regulating medical devices is the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). This agency is part of the Ministry of Health (Ministerio de Salud).

2. Relevant Regulations

The Peruvian medical device regulatory process is based on Law No. 29459 (Law on Medicines, Medical Devices and Health Products) and Supreme Decree No. 016-2013-SA and its amendments.

Medical devices in Peru are classified into Class I, Class II, Class III & Class IV.

3. Time estimation

Depending on the classification of medical devices, the average registration period is 4-6 months, and the registration period for certain products with high risk levels will be appropriately extended.

4. Local Representatives

For manufacturers headquartered outside of Peru, they are also required to appoint an authorized representative as the Peruvian Registration Holder (PRH), who is primarily responsible for processing medical registration application submissions and communicating with the authorities, as well as post-marketing matters.

5. Successful Cases