Is your product Borderline or Boundary?

gloizouUncategorized

Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.Borderline products are those that have characteristics of both medical devices and other products such as:–      Borderline between medical devices and medicinal products,–      Borderline between medical devices and substances of human origin–      Borderline between medical devices and cosmetic products–      Borderline between medical devices and personal protective equipment It’s important to understand the mode of action of the product to truly determine the regulatory framework. Incorrectly classifying a product can result in huge financial loss. In the case of borderline products, careful assessment[…]

Continue reading …

TGA ARTG Medical Device Sponsorship

gloizouTGA Sponsor

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Cosmetics: Miscellaneous: George Loizou |[…]

Continue reading …

Software As A Medical Device

gloizouUncategorized

The TGA has proposed new classification rules for software based medical devices, including smart phone apps. This means that classification rules are now based on risk to individual or public health rather than the intended purpose. In summary, very few software based devices will be class I. Transition periods apply for those currently ARTG entered, otherwise new rules apply Feb 2021. SPEAK TO US TODAY for further information Contact us on: @ [email protected] 0433124266

Continue reading …

TGA ARTG Medical Device Sponsorship

gloizouUncategorized

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Australian TGA Sponsor for[…]

Continue reading …