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...
Mandatory Registration Scheme for Non-Notified Medical Device in India
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...
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