Company intelligence
Arazy Group Consultants Inc.
Medtech Regulatory Affairs Technology explicitly designed for Regulatory Affairs Professionals like you!
About Arazy Group Consultants Inc.
Arazy Group Consultants Inc. is the inventor of global medtech registration technology providing services and products designed to streamline, simplify, and expedite international market access affairs for all types of medical and IVD devices. With the launch of LICENSALE® - Global Medtech Registration System in 2013, Arazy Group took the lead on the provision of advanced registration and license management technology solutions, designed specifically for the medical and IVD device industry. Staying true to its company mission to make the best medical devices and medical practice available to patient and physicians around the world, LICENSALE® delivered thousands of new products registrations, amendments, renewals, and transfers of licenses over the past seven years. Leveraging on their experience and the latest advancement in software, database management, machine learning and A.I., Arazy Group developed the next generation in MedTech registration and license management software- LICENSALE® 2.0, REGISLATE® and the EUDAMEDtech© system Advanced solutions rapidly adopted by the global medtech industry and becoming the gold standard of market access license management. Arazy Group is based in Vancouver, British Columbia, Canada. Arazy Group has additional offices in the US, Argentina, Israel, Turkey, Korea and throughout Europe and is operating globally in 140 countries. Please contact us for more information or visit our website: http://arazygroup.com.
Verified activity
Signals from Arazy Group Consultants Inc.
9 published signals
Research & Knowledge
Arazy Group Consultants Inc. notes that the Medical Device Authority (MDA) has published the first edition of MDA/GD/0072: Change Management for Registered Medical Devices introducing a risk-based framework for managing modifications to registered devices.
Reported by Arazy Group Consultants Inc.
Legal & Regulatory
Arazy Group Consultants Inc. notes clarified pathways and simplified requirements for certain European-aligned devices in Egypt.
Reported by Raymond Kelly
Legal & Regulatory
Arazy Group Consultants Inc. highlights higher expectations for clinical evidence, patient diversity, and RWD/RWE in Canada.
Reported by Raymond Kelly
Legal & Regulatory
Arazy Group Consultants Inc. reports increased flexibility for documentation alongside stronger MFDS oversight in South Korea.
Reported by Raymond Kelly
Legal & Regulatory
Arazy Group Consultants Inc. noted that the EDA clarified import and registration requirements for medical devices and IVDs relying on the European regulatory framework in Egypt.
Reported by Arazy Group Consultants Inc.
Legal & Regulatory
Arazy Group Consultants Inc. noted that new amendments introduced greater flexibility for Class I device transitions, product modifications, and supporting documentation in South Korea.
Reported by Arazy Group Consultants Inc.
Legal & Regulatory
Arazy Group Consultants Inc. noted that Health Canada issued updated clinical evidence guidance for Class II, III, and IV medical devices in Canada.
Reported by Arazy Group Consultants Inc.
Presence & Recognition
Arazy Group Consultants Inc. released the full recorded session of the Arazy Group RegTalk featuring industry experts on MedTech manufacturers and regulatory shifts.
Reported by Raymond Kelly
Legal & Regulatory
Arazy Group Consultants Inc. reported that Saudi Arabia's SFDA has established new lifecycle risk communication requirements under guidance MDS-G-029, requiring manufacturers to integrate safety communication into post-market surveillance systems and submit dual-language safety updates through the GHAD platform.
Reported by Raymond Kelly