Question 1

What is DIGEMID and why is it important for medical device companies?

Accepted Answer

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas / General Directorate of Medicines, Supplies and Drugs) is Peru's National Authority for Medicines, Medical Devices and Health Products. As a public entity within the Ministry of Health (MINSA), DIGEMID regulates medical devices, IVDs, pharmaceuticals, and health products in Peru's growing medical device market. All medical device companies must obtain DIGEMID sanitary registration and maintain compliance to sell products in Peru.

Question 2

What are the most important regulations for medical devices in Peru?

Accepted Answer

Key regulations include: Law No. 29459 (Law of Pharmaceuticals, Medical Devices, and Health Products) and Supreme Decree No. 016-2013-SA (regulatory framework for medical device registration and control). In 2024-2025, MINSA announced draft regulations (Resolution No. 734-2024-MINSA) to enhance device registration, control, and health monitoring. This page tracks all major regulatory updates and DIGEMID policy changes from premium regulatory intelligence sources.

Question 3

How are medical devices classified in Peru?

Accepted Answer

Peru classifies medical devices according to risk level from Class I (low risk) to Class IV (high risk), similar to international classification systems. The classification determines registration requirements, review timelines, and post-market surveillance obligations. DIGEMID provides classification guidance based on intended use, invasiveness, duration of contact, and anatomical location.

Question 4

What is a Peru Registration Holder and do foreign manufacturers need one?

Accepted Answer

A Peru Registration Holder (Local Holder) is a legal entity established in Peru required for foreign medical device manufacturers without a physical presence in Peru. The Local Holder acts on behalf of the manufacturer in all regulatory interactions with DIGEMID, including sanitary registration, post-market surveillance, and compliance activities. All foreign companies must appoint a Local Holder to register and sell medical devices in Peru.

Question 5

How often does DIGEMID publish new regulations and updates?

Accepted Answer

DIGEMID publishes regulations and updates regularly through Ministerial Resolutions (RM) and Supreme Decrees. In 2025, notable updates include Resolution Ministerial N° 049-2025/MINSA (pharmacovigilance practices) and ongoing public consultation on new medical device regulations. This page aggregates DIGEMID and MINSA news from 7 premium commercial sources to provide daily updates on regulatory changes and enforcement actions affecting the Peru medical device market.

Question 6

How can I stay updated on DIGEMID regulatory changes?

Accepted Answer

This page automatically aggregates DIGEMID and Peru medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, and others. Pure Global provides comprehensive regulatory support for Peru market access.

Question 7

What sources does this DIGEMID news page aggregate from?

Accepted Answer

We aggregate Peru and DIGEMID news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Pacific Bridge Medical, Emergo by UL, Asia Actual, Citeline MedTech Insight, Pure Global's proprietary Peru research team, and Qualtechs. All sources are filtered to show only Peru-related regulatory updates using advanced keyword matching including DIGEMID, MINSA, Law 29459, and Peru-specific terminology.

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