Copenhagen, Denmark – 16 August 2016. Monsenso, today announced that its mHealth solution received a Class I medical-device certification, from the Australian Register of Therapeutic Goods Administration (TGA).
The mHealth solution received the TGA certification in cooperation with Emergo, a consultancy company specialising in regulatory compliance for medical devices, with funding from the Danish Market Development Fund.
Thomas Lethenborg, CEO at Monsenso, commented “We are very satisfied that the Monsenso mHealth solution received the TGA certification and is now ready to be launched in the Australian market. Although we already have a customer in Australia, this certification provides us with the means to commercialise the solution nation-wide.”
This certification guarantees that a manufacturer’s product meets the essential requirements stipulated by the Australian Register of Terapeutic Administration.
“Holding the right certifications, and offering a high level of data security is essential for healthcare providers in all markets –including Australia. Therefore, it is important that Monsenso possesses the necessary quality control standards and adequate security measures to succeed world-wide” added Mr. Lethenborg.
The next steps for Monsenso are to obtain the ISO 13485 Certification; the ISO 27001 Data Security Certification; and to become HIPAA and FDA compliant. These certifications will be also obtained with the monetary support granted by the Danish Market Development Fund. You can download this article as PDF in English and Danish.
As of 23 May 2023, Monsenso does no longer hold the TGA certification.