MEDICAL DEVICE REGISTRATION.

Registration of Medical Devices in Peru

The registration of medical devices in Peru is a mandatory process to guarantee the safety and efficacy of products used in medical care. The competent authority for the registration of medical devices in Peru is the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) of the Ministry of Health.

Requirements for Registration

To register a medical device in Peru, the following requirements must be met:

1. Submit the technical documentation of the device, including the description, specifications and user manual.
2. Provide information on the manufacturing and quality control of the device.
3. Perform safety and effectiveness tests on the device.
4. Obtain certification in compliance with applicable international and national standards.
5. Pay the corresponding registration fee.

Classification of Medical Devices

Medical devices are classified into four categories, depending on their level of risk:

1. Class I: Low-risk devices, such as gloves and bandages.
2. Class II: Moderate risk devices, such as anesthesia equipment and vital signs monitors.
3. Class III: High-risk devices, such as implants and active implantable devices.
4. Class IV: Very high-risk devices, such as radiation therapy devices.

Benefits of Registration

Registering medical devices in Peru offers several benefits, including:

1. Guarantee of safety and effectiveness of the devices.
2. Protection of public health.
3. Access to accurate and up-to-date information about the devices.
4. Facilitation of trade and import of devices.