Medtech Reg Progress In Russia, CIS And Eurasian Union At Operational Level

Various economies of the Commonwealth of Independent States (CIS) and the Eurasian Economic Union (EAEU) are pressing ahead with medtech regulatory changes nationally and/or regionally, which can only be good for the delivery of quality care over the long term. But a question mark still hangs over the official start date of the EAEU medtech regulatory system; a formal postponement may be decided soon.

The national governments of Kazakhstan, Kyrgyzstan, Uzbekistan and Russia have been busy updating and progressing their medical technology regulatory frameworks in recent months. But most attention in the region is focused on the structures being built for the regional five-member Eurasian Economic Union (EAEU), and whether a deferral of the Jan. 1, 2022, start date is needed.

Earlier this year, Russian medtech industry representatives saw a political decision to postpone the harmonized EAEUmedtech system as inevitable, for...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

More from Europe

Global Medtech Guidance Tracker: September 2024

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

TRiCares Initiates EU Pivotal Study For Topaz Tricuspid Valve Replacement

 

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.

J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

More from Geography

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

Biocomposites Fully Acquires SYNICEM And Subiton Lines, Launches NanoBone In UK

 

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.

Senseonics Readies For US Launch Of 'World’s First One-Year CGM'

 

US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.