🇵🇪Peru Medical Device Regulations

Medical Device Price Reporting Requirements

Requires drugstores, laboratories, and pharmacies to report commercial pricing of medical devices to DIGEMID. Amends pharmaceutical establishment regulations.

Amendment to Medical Device Registration Requirements

Modifies D.S. 016-2011-SA with specific criteria for new and modified device registrations, labeling requirements, terms and definitions, violations and penalties.

Medical Device Registration and Sanitary Surveillance Regulation

Base regulation for medical device registration, control, and sanitary surveillance. Establishes classification (Class I-IV), registration procedures, and requirements.

Pharmaceutical Establishments Regulation

Rules for pharmaceutical establishments including manufacturers, importers, and distributors of medical devices. Establishes operational requirements.

Law of Pharmaceuticals, Medical Devices, and Health Products

Primary law governing pharmaceuticals, medical devices, and health products in Peru. Establishes the regulatory framework and DIGEMID authority.