Understanding Medical Device Registration in Peru
Updated On: 25/01/2024
Regulatory Authority: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
The General Directorate of Medicines, Supplies and Drugs (DIGEMID) is a technical regulatory institution established by Legislative Decree No. 584 of April 18, 1990, with the primary goal of ensuring access to safe, effective, and quality medicines. The policy outlines the development of activities, continuous improvement in processes, establishment and maintenance of a Quality Management System, and providing workers with necessary training and resources to achieve these objectives.
Link for Regulatory Authority: https://www.digemid.minsa.gob.pe/
Local Regulation:
Classification: Class I, II, III and IV
Listing or Registration Requirements: DIGEMED has implemented the VUCE (Single Window of Foreign Trade) electronic system.
Documents Required: Under the medical device provisions of the Law 29459 for the purpose of registration manufacturers must provide the following information:
Registration Timeline:
Registration Fee:
License Validity: 5 Years
Special Labelling Requirements: Documents and Labeling must be in Spanish
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
Why Choose Us
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.