electromedical equipment – Pharma Consulting https://pharmaconsulting.pbt.com.bo ConsultorĂ­a Regulatoria Inteligente Fri, 22 Oct 2021 17:58:03 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 List of medical devices that can be marketed directly to end-users in PerĂș https://pharmaconsulting.pbt.com.bo/digemid-approved-list-of-medical-devices-that-can-be-marketed-directly-to-the-end-user/ Tue, 20 Aug 2019 22:55:27 +0000 https://pharmaconsulting.pe/?p=1479

The Directorate of Medicines, Supplies, and Drugs – DIGEMID, issued a list of medical devices that can be marketed directly to end-users. In order to acquire a particular product, users must present a medical prescription, if required.

Biomedical Equipment

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) biomedical equipment, only to be sold to health professionals and institutions that provide health services (IPRESS).

Medical Devices

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to health professionals and institutions that provide health services (IPRESS).

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to patients, upon presentation of a medical prescription.

Class I (non-sterile, low risk) only to be sold to commercial establishments.

In Vitro Diagnostic Medical Devices

Self-tests, reagents, and laboratory equipment.

Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.

 

Source: DIGEMID

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