Gruppo Farmaimpresa expands its international presence with the registration of Flogorex Med Spray with the Moroccan Agency for Medicines and Health Products. Flogorex Med Spray is a Class I medical device indicated for osteo-articular inflammation, soft tissue trauma, tendinitis, contusions, edema and painful joint manifestations, available for international distribution and private label projects.
Borox Ear Spray is a high-quality ear medical device for hygiene and protection, officially registered in the United Arab Emirates (UAE) through Medgenix Pharma LLC FZ, Dubai. The product features a specialised formula with 3% boric acid, lactic acid and sodium docusate. As certified manufacturers, we offer Borox Ear Spray for private label distribution, providing…
Medical Device for Nasal Congestion and Rhinitis: Clinical Results on Symptoms and Quality of Life Rinofast is a medical device for nasal congestion and symptoms associated with rhinitis and rhinosinusitis. The prospective observational clinical study evaluated treatment efficacy using the Sino-Nasal Outcome Test (SNOT-22), a validated questionnaire measuring nasal symptoms and quality-of-life impact. The SNOT-22…
Nasal Spray with N-Acetylcysteine and MSM: Effective Solution for Respiratory Health | Certified in the United Arab Emirates We are proud to announce that the Ministry of Health in the United Arab Emirates has approved our Class I medical device! Our nasal spray, formulated with N-acetylcysteine and MSM (0.9% NaCl), has undergone rigorous evaluation by…
Registration of Class IIa Medical Device for Gastroesophageal Reflux at the Department of Health in Hanoi, Vietnam The Department of Health in Hanoi, Vietnam officially registered our Class IIa medical device. Additionally, it’s important to note that the device holds an MDD certificate extension. The device is an oral emulsion composed of key actives: low…
Effective vaginal relief: medical device registered in Vietnam for women’s well-being GFI proudly announces that we have successfully registered a Class IIa medical device in Vietnam, formulated with natural ingredients. This device is a vaginal ovule composed of hyaluronic acid, lactic acid, Centella Asiatica, calendula, chamomile, and tea tree oil. Indicated to addressing a wide…
Gruppo FarmaImpresa completes the registration process for an oral emulsion for Gastroesophageal Reflux Disease Treatment With pride, we present our recent success in obtaining registration for a Class IIa medical device in Vietnam. This device, based on low molecular weight hyaluronic acid, sodium alginate, myrrh extract, and simethicone, is indicated for the treatment of gastroesophageal…
Clinical study: Vaginal ovules containing hyaluronic acid, polycarbophil and lactic acid for vulvovaginal symptoms such as burning, dryness, irritation, dysuria and dyspareunia Gruppo FarmaImpresa is required, for regulatory reasons, to regularly follow a postmarketing surveillance system called postmarketing clinical follow-up (PMCF). The PMCF is a continuous and proactive process that aims to continuously evaluate the…
A question and answer document has been published by the European Commission, the purpose of which is to facilitate the application of Regulation (EU) 2023/607 The main objective of the European Medical Device Regulation (MDR) 2017/745 is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of…
Gruppo FarmaImpresa is among the first Italian companies to obtain MDR certifications for some of its substance-based medical devices As a reminder, the new Regulation (EU) 2017/745 or MDR (Medical Device Regulation) is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place…