Medical device registration in Peru - a brief guide

Foreign manufacturers who are willing to enter the Peruvian medical device market might face the challenge of managing local regulatory procedures. Understanding the Peruvian regulatory framework is essential for successful registration of your medical devices.

Peruvian medical device regulatory bodies

The medical device market in Peru is regulated by Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), which is a part of the Ministry of Health (Ministerio de Salud or MINSA).

It is the Directorate of Sanitary Authorizations that makes decisions regarding registrations and denials of medical devices in Peru. In general, the Directorate of Sanitary Authorizations is responsible for:

• Registration of medical devices
• Renewal
• Modifications
• Denial
• Suspension
• Cancellation of a Sanitary Registration or Sanitary Certificate of pharmaceutical products, medical devices and sanitary products based on the national medical device regulations.

Peruvian medical device regulations

The Peruvian regulatory process for medical devices is based on the Law No. 29459 (Law of Pharmaceuticals, Medical Devices and Health Products) and the Supreme Decree Nº 016-2013-SA (Regulation for Registration, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products ) with amendments. A number of other regulations are applicable to medical devices in Peru.

Medical device definition in Peru

Any type of instrument, equipment, implement, reactive, calibrator in vitro or software that has been manufactured to be used in human beings. Those instruments could be used for one or more objectives such as:

• Diagnostic, prevention, monitoring, treatment or relief of a disease
• Diagnostic, monitoring, treatment, relief or compensation of an injury
• Search, replacement or modification from an anatomical or physiological process
• Maintenance and life support
• Contraception
• Disinfection of medical devices.

Medical device classification in Peru

Peruvian classification of medical devices takes into consideration the risks of duration of contact with the body, invasiveness, as well as local and systemic effects of a device. It is based on IMDRF guidelines (GHTF standard).

General requirements for medical device registration documentation in Peru

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

1. Application
2. Free Sales Certificate or analogue
3. Good Manufacturing Practice or similar
4. Technical Report
5. Technical and Analytical Studies
6. Disposal methods (when applicable)
7. Draft of package labeling
8. Fee
9. Others (depends on the class - see below) 

DIGEMID requirements based on the risk factors

The content and volume of the registration dossier depends on the risk class of a device as shown in the table.

Registration timelines and cost

Official medical device registration timelines for medical devices in Peru are:

• Class I - 60 days
• Class II - 90 days
• Classes III, IV - 120 days

DIGEMID regitration fees:

• Class I - approx. 400 euros
• Class II - approx. 460 euros
• Class III - approx. 510 euros
• Class IV - approx. 580 euros

Regulatory documentation management

DIGEMED has implememnted the VUCE (Single Window of Foreign Trade) electronic system. It facilitetes the coomunication between the regulator and manufacturers of medical devices and can be used for inquiry, consultation, advice and submissions.

The VUCE system is an integrated electronic system that allows parties involved in trade and international transport to manage the documentation required through electronic way. It means, a lot of formalities can be gone through using electronic communication with the Peruvian regulator.