Certain Medical Devices in India will be Considered as Drugs as of 30 June 2022
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...
Medical Device Registration and Supply in Ukraine
By Fajar Dumadi | March 11, 2022 In regards to the enforcement of martial law on February 24th, 2022, the Ministry of Health allows the supply of medical devices, in-vitro diagnostics, and implantable medical devices that do not comply with the requirements of the...
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...
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