Asia Reg News: AHWP Catch-Up, Korea, Malaysia, Indonesia and Vietnam Updates

 
• By Ashley Yeo
  
Generate a summary of this article
Listen to this article
Beta

Part 1 of this month’s Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This feature is hosted by Medtech Insight, the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Myanmar, Philippines, Singapore, Asean Large Fabric Flags, Blue Sky, Windy Day

The recent Asian Harmonization Working Party (AHWP) technical committee (TC) leaders conference was hosted in April by the current chair, Saudi Arabia, in Riyadh. The next annual AHWP meeting is scheduled for the Sultanate of Oman, on 11-14 November, an event that offers a good platform for networking with regional regulatory professionals, as well and as providing knowledge updates.

At the meeting of the TC, addressed by Sasikala Devi Thangavelu of the Malaysian Medical Device Authority (MDA), there was...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

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

SpotifyApple PodcastsWebsite

More from Asia

Global Medtech Guidance Tracker: September 2024

 
• By Vibha Sharma

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.

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

 
• By Brian Bossetta

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation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

Global Medtech Guidance Tracker: August 2024

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

More from Geography

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

 
• By Brian Bossetta

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

 
• By Natasha Barrow

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'

 
• By Natasha Barrow

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.