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.
Medical devices and IVD
• 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.
Household cleaning products and disinfectants
• Soaps and detergents.
• Household hygiene products.
• Surface disinfectants (active against the new coronavirus)
• Absorbent damp cloths.
Galenic products
• Hand sanitizer.
• Medicinal alcohol solutions.
Other products
• 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
Peru registration holder