By Fajar Dumadi | November 23, 2021 On February 8, 2019, the Ministry of Health & Family Welfare, Government of India, has notified that the following devices were regulated as drugs; effective from April 1, 2021: All implantable medical devices CT scan equipment...
By Fajar Dumadi | October 20, 2021 According to the Medical Device Rules 2017, “A medical device that is essential to or that yields information that is essential to the restoration or continuation of a body function important to the continuation of human or animal...
By Fajar Dumadi | October 20, 2021 According to the Regulation (EU) 2017/746 (IVDR) (1) the industry was given until 26 May 2022 to fully implement the regulation; it is required to have the product CE marked by the stipulated deadline. However, according to the...
By Fajar Dumadi | October 20, 2021 The new regulatory updates from Indonesia (2020-2021) include: 1. SIKLARA SIKLARA is an online interactive tool to help prospective medical device registrants define the classification of medical devices and IVDs. This tool...
By Fajar Dumadi | October 20, 2021 Non-notified medical devices were non regulated products; therefore, registration certificate was not required. According to the Medical Device (Amendment) Rules – February 2020 (1), which was enforced in April 2020, all...
EUDAMED Actor Registration Reminder | July 2021 If you sell products in the European Union it is crucial to conduct the actor registration in Eudamed to receive your SRN. Once your organization has been registered on Eudamed you will receive your required SRN number. ...
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