In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the IVD and medical device market. This agency registers devices, issues operation licenses, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding medical devices imported to and sold in Perú.

DIGEMID classifies products into three main categories: supplies, medical devices, and IVDs. Bill 29459, Supreme Decree 019-97-SA, Supreme Decree 016-2011-SA, and associated amendments define the regulations for IVDs and medical devices. 

Peruvian regulatory authorities group medical devices according to a four-tier classification system. This classification scheme determines our registration route. Ministerial Resolution 234 of 2017, title II, article 4, outlines medical devices classification in Perú. It includes devices class I, class II, class III, and IV. Devices further divide into active, invasive, and non-invasive.

The classification system for IVDs and medical devices is roughly the same. DIGEMID classifies IVDs into four classes, namely I, II, III, and IV, based on risk.

Regulatory authorities in Perú are not quite flexible on what we can put into a single registration application. There are vast criteria on what can be put together as a family of devices. Different types of devices can’t be grouped together. Devices sold by different manufacturers can’t be grouped together either. Grouping options depend much on the information existing in the Free Sale Certificate (FSC), CFG, and the product manual.

Before you begin the registration process, you’ll need to appoint a local representative, as Pharma Consulting, to communicate with DIGEMID on your behalf. This way, your company can maintain control over the registration. If a distributor is your in-country representative, they will list themself as the owner of the registration.

All registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for five years.

Source: Pharma Consulting

Learn more about our medical device market at 997556699 or by mail info@pharmaconsulting.pe

The Directorate of Medicines, Supplies, and Drugs – DIGEMID, has established the mandatory registration of respirators for medical use as of January 1, 2021. This mandate affects institutions and pharmaceutical establishments that import, store, manufacture, or market N95, KN95, FFP2, FFP3 respirators for medical use, and the like, as they are considered class I medical devices.

Individuals and businesses not registered with DIGEMID will not be permitted to import and distribute this kind of products.

This new requirement will take effect on January 1, 2021.

The requirements to register respirators for medical use are established by DIGEMID. You can learn more about the procedure by clicking here.

The N95 respirator is a respiratory protection device designed to achieve a good facial fit and very efficient filtration of airborne particles. The N95 designation means that, when carefully tested, the respirator blocks at least 95 percent of very small particles (0.3 microns). If properly fitted, the filtration capabilities of N95 respirators exceed those of surgical masks.

The KN95 respirator is not resistant to oily airborne particles. It is recommended to use it in conjunction with a face shield.

FFP2 and FFP3 particulate respirators are not resistant to fluids. It is recommended to use them in conjunction with a face shield.

Also called a three-fold mask or disposable mask, it is a medical material that covers the mouth and nose, and provides a barrier to minimize the direct transmission of infectious agents between medical personnel and patients.

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

Source: DIGEMID

The National Authority of Pharmaceutical Products, Medical Devices, and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the Peruvian sanitary registry.

Medical Devices (MD) Class I, low risk: Up to thirty (30) calendar days.

Medical Devices (MD) Class II, moderate risk: Up to sixty (60) calendar days.

Medical Devices (MD) Class III, high risk: Up to ninety (90) calendar days.

Medical Devices (MD) Class IV, critical risk: Up to ninety (90) calendar days.

Due to this modification to the current regulations, manufacturers and importers are expected to reduce the time to market their products.

All medical device registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for ten years.

Learn more about MD registration in Perú and contact us at 997556699 or by mail info@pharmaconsulting.pe

According to D.R. No. 033-2017-DIGEMID-DG-MINSA, published early this year, DIGEMID issued a list of medical devices that may be marketed directly to end-users. This document does not list every medical device but establishes a criterion based on MD risk classification.

Laboratories and droguerías (pharmaceutical establishments) may directly sell all classes of medical devices to healthcare institutions, health professionals, and patients.

Biomedical equipment may be sold only to health professionals and healthcare institutions like hospitals and clinics.

Class III (high risk) biomedical equipment, may only be sold to health professionals and healthcare institutions.

Self-tests, in vitro diagnostic reagents, and laboratory equipment may only be sold to healthcare institutions.

Self-tests, in vitro diagnostic reagents, and laboratory equipment may only be sold to healthcare institutions.

The seller must keep proof of payments (invoices or tickets) on record. Additionally, for health professionals, a copy of the registration card or registration number must be kept; and for patients, a copy of the prescription.

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

Source: DIGEMID

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.

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).

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.

Self-tests, reagents, and laboratory equipment.

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

Source: DIGEMID