Understanding Medical Device Registration in Peru

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

• Decree D.S.001-2012-SA
• Decree D.S.016-2011-SA
• Law No. 29.459
• Decreet Supremo No. 003-2020-SA

Classification of Medical Devices

Class I, II, III and IV

Listing or Registration Requirements

DIGEMED has implemented the VUCE (Single Window of Foreign Trade) electronic system.

Documents Required for Peru Medical Device Registration

Under the medical device provisions of the Law 29459 for the purpose of registration manufacturers must provide the following information:

• Application
• Free Sales Certificate or analogue
• Good Manufacturing Practice or similar Technical Report
• Technical and Analytical Studies
• Disposal methods (when applicable)
• Draft of package labeling

Registration Timeline

• Class I devices: 60 days.
• Class II devices: 90 days
• Class III and IV devices: 120 days.

Registration Fee

• Class I – 400 euros
• Class II – 460 euros
• Class III – 510 euros
• Class IV – 580 euros

License Validity

5 Years

Special Labelling Requirements

Documents and Labeling must be in Spanish

Who should make this communication?

• Manufacturer
• Authorized Representative
  

When to make this communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk