Arazy Group Blogs and Case Studies
La Technologie des Dispositifs Médicaux
La Technologie des Dispositifs Médicaux ne va pas sans celle des affaires réglementaires ceci afin de répondre aux défis d'aujourd'hui pour l’accès aux marchés internationaux. Le paysage réglementaire mondial continue d'évoluer rapidement ; de nouvelles exigences sont...
Mundomedis and Arazy Group Sign Cooperation MoU
Mundomedis FZCO and Arazy Group recently signed a cooperation memorandum. Both companies will cooperate to support Mundomedis’ global medical device portfolio companies by streamlining their global regulatory processes through Arazy Group’s Licensale online platform.
Certain Medical Devices in India will be Considered as Drugs as of 30 June 2022
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.
Medical Device Registration and Supply in Ukraine
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.
Medical Devices Registration Exemption in Pakistan
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.
Changes to the Implementation of IVDR
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.
Mandatory Registration Scheme for Non-Notified Medical Device in India
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.
EUDAMED Actor Registration
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.
Unique Device Identifier (UDI) Submission as part of Pre-Market Requirements
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...
LICENSALE Mobile Now Available!
Medtech Registration Just Became Mobile LICENSALE® Mobile is now available on the App Store and Google Play. Login with your portal registration credentials to view your registration projects from anywhere. View your products' real-time marketing statuses...
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Dictum Health
Versah LLC
Schiller AG
Terragene
Terragene
Likamed
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