Tag: Medical Devices

Cassation Court Confirmed Legitimacy and Reasonableness of FAS Decision

On 15 January 2020, the Arbitration Court of the Moscow District confirmed legitimacy and reasonableness of FAS decision In February 2019, FAS found that “Regionpharma” Ltd., “Globalmedtech” Ltd., ...

Unique Laser Medical Equipment To Be Produced in the Moscow Region SEZ

Vasari Lasers plans to implement an investment project to produce laser equipment for medical institutions. The enterprise will be located in Istok SEZ in Fryazino near Moscow. According to Deputy ...

FDA Approved New Software System for Insulin Control

Tandem Diabetes Care has claimed approval in the US for a new software system that can be used in “artificial pancreas” systems to automatically check blood glucose levels in diabetics and deliver the...

FDA Cleared for Marketing in the U.S. First Fully Disposable Duodenoscope

The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and acce...

Russia Introduced New Updates to Strengthen Control Procedures for Medical Devices

medical-devices
In November several new updates were introduced to strengthen control procedures for medical devices and pharmaceuticals in circulation on the market from Russian healthcare regulators. On 9 Novemb...

Nordavind-Dubna Received European Certificate for ECG Dongle Electrocardiograph

medical-devices
Nordavind-Dubna, a resident of the Moscow Region SEZ (part of the Nordavind Group of Companies) received a CE certificate of the European standard for a device of its own design - an ECG Dongle electr...

FDA Cleared First Duodenoscope with Sterile, Disposable Elevator Component in the U.S.

r&d
The U.S. Food and Drug Administration cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleane...

FDA Prepared Guidance on Device Export Certificate Denials

fda
The US Food and Drug Administration (FDA) finalized guidance explaining how the agency handles denials of requests for a certificate to a foreign government (CFG) for medical devices and how to reques...

TGA’s Ability to Enforce Proposed Software Rules Questioned by Industry Representatives

The Medtech industry has questioned whether the Therapeutic Goods Administration (TGA) can ensure all Software as a Medical Device (SaMD) products are included in the Australian Register of Therapeuti...

FDA’s Pivot on Progressive Approvals for Devices Disappointed US Senators

medical-devices
In a letter to top US Food and Drug Administration (FDA) officials Sens. Elizabeth Warren and Patty Murray say they are concerned about the agency’s renewed interest in a progressive approval system f...

FDA on Concerns about Sterilization Facility Closures and Medical Device Availability

fda
As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely monitoring the supply chain effects of closures and p...

First Russian Neonatal Mobile Incubator Registered by Rostec

shvabe
The Shvabe Holding of Rostec State Corporation received the Russian registration certificate of Roszdravnadzor for the BONNY neonatal mobile incubator. This is the first domestic device of this type. ...

FDA Modified List of Standards for Premarket Device Reviews

medical-devices
The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Adminis...

FDA Published Statement on Materials Evaluations in Medical Devices

medical-devices
Innovation in medical devices, spurred in many cases by advances in materials sciences, continues to improve the lives of patients. The growing number of available materials used in today’s medical de...

FDA Alerted Medical Device Manufacturers to 11 Vulnerabilities

fda
Following other regulators’ warnings, the US Food and Drug Administration (FDA) on Tuesday alerted medical device manufacturers and other stakeholders to 11 vulnerabilities that may allow for remote c...

FDA Published New Draft Guidance on Electronic Device Submissions

medical-devices
Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) published a new draft guidance with “both binding and nonbinding provisions” related to electronic subm...