Emergency decree No. 0-26-2020 established various exceptional and temporary measures to prevent the spread of the new coronavirus (COVID-19) in Perú. Our national regulator, DIGEMID, has established the prioritization of several administrative procedures:

• Exceptional authorizations for individual treatment of patients, which grants the bearer authorization to import medicines, biological products, and medical devices.

• Registration of pharmaceutical products related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of medical devices and in-vitro diagnostic medical devices related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of household cleaning products and disinfectants.

Imported cosmetic products that are marketed in the Andean subregion must comply with cGMP according to the new regulations and international standards.

• Examination gloves.

• Surgical gloves.

• Reagent kits for molecular tests (new coronavirus)

• Quick hygiene tests for surfaces.

• Rapid IgG and IgM antibodies tests.

• PCR type molecular biology kits.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Soaps and detergents.

• Household hygiene products.

• Surface disinfectants (active against the new coronavirus)

• Absorbent damp cloths.

• Hand sanitizer.

• Medicinal alcohol solutions.

• Non-sterile mask o face mask.

• Disposable mask.

• Disposable protective mask, non-sterile, N-95 type.

• Single-use gown for patients, non-sterile.

• Single-use gown, non-sterile.

• Reusable patient gown, non-sterile.

• Non-sterile surgical caps.

• Non-slip insole shoes.

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about product registration in Perú.

Source: DIGEMID

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