一.The regulatory authority for medical devices in Peru
The regulatory authority for medical devices in Peru is the General Directorate of Medicines, Medical Supplies, and Drugs (DIGEMID), which is primarily responsible for the registration, supervision, and management of medical devices; document review; technical evaluation; safety testing; quality management system audits; and the approval of medical device marketing authorizations.
Link to the regulatory agency’s official website: https://www.digemid.minsa.gob.pe/webDigemid/
Database link: https://www.digemid.minsa.gob.pe/rsDispositivos/
Law No. 29459 and its amendment, Supreme Decree No. 020-2024-SA
Supreme Decree No. 016-2011-SA and its amendment, Supreme Decree No. 010-2023-SA
二.Regulatory Framework
Law No. 29459 and its amendments, Supreme Decree No. 020-2024-SA
Supreme Decree No. 016-2011-SA and its amendments, Supreme Decree No. 010-2023-SA
三.Medical Device Risk Classification
四.Authorized Representative
An entity legally established in Peru (with legal existence and a physical address), registered with DIGEMID and holding the appropriate authorization. Typically, this is a DIGEMID-authorized Establecimiento Farmacéutico (pharmaceutical establishment), such as a Droguería (wholesale/distribution company) or a laboratory.
五.Prerequisites for Market Access
Both MDs and IVDs require an ISO 13485 certificate to demonstrate the quality system at the actual manufacturing site;
For manufacturers located outside Peru, an Authorized Representative must also be designated to serve as the Peruvian Registration Holder (PRH);
The applicant must prepare detailed technical specifications, manufacturing processes, and information on materials used to enable the regulatory authority to assess the product’s quality and safety.
六.Registration Documents
七.Registration Language
Spanish
八.Registration Process, Timeline, and Official Fees
- Registration Process
Standard Registration Process: Confirm product classification → Prepare registration documents → Designate a distributor → Submit documents to DIGEMID → Obtain the certificate (valid for 5 years)
- Registration Fees (subject to final determination by DIGEMID)
Class I (Low Risk): 462 USD
Class II (Low-to-Medium Risk): 524 USD
Class III (Medium-High Risk): 611 USD
Class IV (High Risk): 685 USD
- Official Review Timeline
Class I: Approximately 60 days
Class II: Approximately 90 days
Class III: Approximately 120 days
Class IV: Approximately 120 days
九.Frequently Asked Questions
What should be done if changes are made to a medical device or IVD product that has already obtained a Peruvian registration certificate?
How long is the registration valid for a medical device after it has been registered in Peru?
