YesDTC, BioElectronics receive Japanese regulatory review notification for ActiPatch and Allay products

Published on July 27, 2010 at 8:27 AM · No Comments

YesDTC Holdings, Inc. (OTC Bulletin Board: YESD), a direct-to-consumer marketer and global distributor of consumer goods and products and BioElectronics Corp. (Pink Sheets: BIEL), manufacturers of innovative pain relieving medical devices, today announced the companies have received notification of the pending review by Japanese government medical device regulators for the ActiPatch™ and Allay™ Menstrual  Relief products.  This review will take place on Wednesday, July 28th.

The initial analysis by YesDTC's attorneys has been very favorable toward the Company's ability to begin marketing in Japan as several similar devices are already on the market.  This regulatory review is designed to verify that Japanese regulatory agencies will place ActiPatch and Allay in the same category as these currently marketed devices or if additional information and or testing will be required.  

BioElectronics and YesDTC recently announced several important product line enhancements specifically tailored to suit the needs of the highly discerning and quality conscious Japanese marketplace.  Additionally, upon release, BioElectronics will make the recently announced back pain belt available to the Japanese marketplace.

Andrew Whelan, CEO of BioElectronics commented, "We view the Japanese market as being highly significant to our future success.  There is a history of Japanese regulators closely mirroring the medical device classifications that had earlier occurred within the European Union, where we are a Class IIa device.  This pending review, which will take place this week, should offer us a great deal of information about our ability to be successful in what we believe will be a highly profitable market."

Source:

YesDTC Holdings, Inc.

Posted in: Device / Technology News | Women's Health News

Tags: ,

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Filipino | Ελληνικά | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post
You might also like... ×
DNA-directed RNA interference and hepatitis C: an interview with Carl Stubbings, Chief Business Officer, Benitec Biopharma