A February 8, 2019 announcement by the Ministry of Health & Family Welfare, Government of India declaired that certain health devices were to be regulated as drugs, effective April 1, 2021. That deadline has been extended.

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 life” are exempted from either Establishment Certificate and/or Enlistment/Registration Certificate.

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.

The new regulatory updates from Indonesia (2020-2021) have been announced.

According to the Medical Device (Amendment) Rules – February 2020 (1), which was enforced in April 2020, all non-notified medical devices can be voluntarily registered with the Central Licensing Authority (CLA) through the online system for medical devices.

Reminder. 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.

As part of IMDRF Key Objectives 2021-2025 (Committee, 2020), the utilization of Unique Device Identifier (UDI) System is deemed as important to standardize information collected by regulators via post-market surveillance activities. The United States Food and Drug...

Regulatory Update: New Guidelines of UK MHRA  The UK MHRA published a new set of guidelines related to the UK medical device regulations starting from January 1st, 2021. From January 1st 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the...

UAE - Medical Device Registration for Israeli Companies The recent peace agreement brings immediate commercial opportunities for Israeli medical technology in the United Arab Emirates and through it to other members of the Gulf Cooperation Council (GCC). Arazy Group...