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…
The new Regulation (EU) 2017/745 or MDR is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place a medical device on the European market. The new Regulation complements and replaces the previous Directives 90/385/EEC and 93/42/EEC, providing more stringent requirements and measures…
The international contract in the field of medical devices. What are its advantages? The internationalization process goes through trade with other parties from different countries. EU reg. 2017/745 has standardized product disciplines between states of the European Union, however, civil and commercial aspects that are not codified by supranational rules remain freely determined between the…
Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.…
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