New international registration for the medical device Revaginal Ovules
Gruppo FarmaImpresa is expanding its presence in international markets with the registration of Revaginal Ovules with the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom’s regulatory authority for medical devices.
This registration allows the medical device to be marketed in the UK and represents another step in the global expansion of medical devices developed by Farmaimpresa.
Why MHRA registration is important for the UK market
The Medicines and Healthcare products Regulatory Agency (MHRA) is the authority responsible for regulating medical devices in the United Kingdom. Following the country’s exit from the European Union, access to the British market requires specific regulatory procedures to ensure that products comply with local requirements.
For international manufacturers and distributors, obtaining MHRA registration is a crucial step toward marketing medical devices in the United Kingdom. Registration demonstrates that the product complies with the required standards and facilitates import, distribution, and commercial development activities.
Obtaining registration for Revaginal Ovules confirms Farmaimpresa’s ability to successfully manage complex international regulatory processes and support its partners in accessing highly regulated markets.
Revaginal Ovules: an MDR medical device for vaginal health
Revaginal Ovules is a Class IIb medical device certified in accordance with the European Medical Device Regulation (MDR) 2017/745.
The MDR currently represents the most rigorous European regulatory framework for medical devices and requires high standards in terms of safety, clinical effectiveness, risk management, post-market surveillance, and manufacturing quality.
For distributors, importers, and international business partners, MDR certification is an important indicator of reliability and facilitates access to numerous markets that recognize European regulatory standards.
The device is also manufactured within a quality management system certified to ISO 13485, an international standard specific to medical device manufacturers.
What are Revaginal ovules used for?
Revaginal Ovules was developed to help restore the physiological balance of the vaginal environment and support the maintenance of the mucosa’s natural defenses.
The main indications include:
atrophic vaginitis;
nonspecific vaginal dryness;
menopausal genitourinary syndrome;
radiation-induced vaginal dryness;
vaginal irritation, burning, and itching;
changes in vaginal pH.
A device designed to support women’s well-being throughout the different stages of life
Vaginal health can be affected by numerous factors, including hormonal changes, menopause, drug treatments, radiation therapy, and changes in the vaginal microbiota.
Under these conditions, symptoms such as dryness, irritation, itching, burning, and discomfort during normal daily activities may occur.
Revaginal ovules were specifically formulated to help maintain a healthy vaginal environment through a combination of ingredients that moisturize, lubricate, and restore balance.
Hyaluronic acid promotes hydration of the mucous membranes, while lactic acid helps rapidly restore the natural pH balance. The presence of polycarbophil also helps maintain the balance of the vulvovaginal ecosystem, supporting the mucosa’s natural defenses.
Due to these characteristics, the product can provide valuable support for women of childbearing age as well as during perimenopause and menopause, when hormonal changes can increase susceptibility to vaginal dryness and intimate discomfort.
Advanced formula with hyaluronic acid and lactic acid
The formula combines active ingredients selected to simultaneously hydrate, lubricate, protect, and restore the vaginal pH balance.
Key ingredients include:
Sodium Hyaluronate;
Lactic Acid;
Polycarbophil;
Vitamin E Acetate;
Tea Tree Oil;
Phosphatidylcholine.
The combined action of these ingredients helps restore the vaginal microbiota and helps relieve symptoms such as dryness, itching, and burning.
International Distribution and Private Label Opportunities
The MHRA registration further expands the commercial opportunities for Revaginal ovules, enabling access to the UK market with a medical device that already complies with the required regulatory standards.
Thanks to the certifications obtained and a formulation developed for women’s intimate well-being, Revaginal ovules represent an attractive solution for distributors, importers, and healthcare industry professionals seeking innovative, market-ready products.
The product is available both under the Farmaimpresa brand and as part of private-label projects for international markets.
The MHRA registration strengthens the product’s international positioning
Obtaining registration in the United Kingdom represents further recognition of the regulatory and quality standards followed during the development of Revaginal ovules.
Compliance with the European Medical Device Regulation (MDR) 2017/745, combined with registration with the MHRA, ensures that the device meets high standards of safety, quality, and reliability—requirements that are increasingly demanded by international markets.
This important milestone confirms the potential of Revaginal ovules as a solution dedicated to women’s health and well-being, supporting the product’s growth in regulated markets.
Interested in distributing Revaginal ovules in your market?
Revaginal ovules is available for international distribution and private label projects.
To receive sales information, technical documentation, or learn more about partnership opportunities, please contact the Farmaimpresa team.
