Medical Devices Registration Exemption in Pakistan
By Fajar Dumadi | October 20, 2021According 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...
Changes to the Implementation of IVDR
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...
Indonesia Medical Device Regulatory Updates 2020-2021
By Fajar Dumadi | October 20, 2021 The new regulatory updates from Indonesia (2020-2021) include: 1. SIKLARASIKLARA is an online interactive tool to help prospective medical device registrants define the classification of medical devices and IVDs. This...
EUDAMED Actor Registration
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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