Medical Devices Today

European Commission Outlines Key Issues In Device Reprocessing Debate

Full article reprinted from "The Gray Sheet" - June 2, 2008

The European Union is taking its first steps towards determining whether to create a uniform policy on the reprocessing of medical devices labeled for single use.

At this early stage of the process, even the most basic issues - such as how to define reprocessing to distinguish it from refurbishing - are still up for discussion.

Some individual countries in Europe have single-use device (SUD) reprocessing laws, in some cases outlawing it and in others allowing it under regulatory oversight.

A regulatory approach in the U.S. has evolved during the past decade in which reprocessed devices are subject to risk-based pre-market review and post-market requirements, including validation of a reprocessor's sterilization and cleaning processes.

U.S.-China Device Talks Yield Some Concessions, But Big Issues Unresolved

This article is reprinted from "The Gray Sheet" – April 28, 2008

A recent meeting between U.S. and Chinese government officials and device industry reps yielded some concessions to opening up China's market, but left many more issues on the table, according to a U.S. industry participant.

"There are a number of outstanding regulatory concerns," said Nancy Travis, VP of global analysis and strategy for AdvaMed, in an interview.

Travis traveled to Guilin, China, the week of April 7 to participate in talks with staffers from the U.S. Department of Commerce and China's State Food and Drug Administration about issues impacting trade between the two nations. In addition to AdvaMed, the Medical Imaging Technology Association and the China Association for Medical Devices Industry represented device firms.

The talks were part of the U.S.-China Joint Commission on Commerce and Trade, a long-standing dialogue vehicle that includes a medical device task force. FDA often participates in the meetings, but did not attend this year.

U.S. Officials, Industry See Border Delays In Impending China Import Reg

From the November 5, 2007, issue of "The Gray Sheet"

U.S. officials with the World Trade Organization and the U.S. device industry are challenging China's government on pending regulations they say will create unnecessary delays in getting devices into China and onto its market.

Decree 95, or Administrative Measures on Examination and Supervision of Imported Medical Devices, was issued by Chinese authorities this summer and is scheduled to take effect Dec. 1.

The measure, which would give substantial new border authority to China's Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ), comes amid growing concerns among the Chinese public about safety of domestic and imported devices.

Japan's Device Payments Will Continue To Decline, Government Official Says

From the October 8, 2007, issue of "The Gray Sheet"

Pressures on reimbursement in Japan will not ease anytime soon and more payment cuts for medical devices are expected in 2008, according to a top Japanese health official.

The U.S. industry sees Japan as a mostly untapped market hindered by government barriers. U.S. device makers have long urged the Japanese health ministry to eliminate its controversial foreign average price rate-setting method, which generally reduces device treatment fees to be more in line with payment levels in lower cost countries.

Global Harmonization Task Force Moves Into "Implementation Mode"

From the September 17, 2007, issue of "The Gray Sheet"

Efforts to harmonize device regulations globally will see more activity over the next year if Larry Kessler has his way.

Kessler, who is director of CDRH's Office of Science and Engineering Laboratories, is in a position to make it happen. In January, he was appointed to an 18-month post as chairman of the Global Harmonization Task Force.

Founded in 1992 by device regulators and industry reps from the United States, Canada, Europe, Japan and Australia to facilitate trade, GHTF has spent much of the past 15 years engaging in meetings and cyclical comment periods to build consensus on a collection of guidance documents.

U.S. Device Industry Tries To Take Active Role In Fashioning India's Regs

From the March 19, 2007, issue of "The Gray Sheet"

U.S. device industry stakeholders are planning formal talks with India's government about the creation of a regulatory body dedicated to medical devices.

Imports constitute 75% of India's $1.5 billion medical device market, projected to grow at a 12%-16% rate up to 2010, according to Pacific Bridge Medical, a consulting firm focusing on Asian markets for medical products. Many U.S. companies already operate in India, and all of them have to deal with the difficult reality that the majority of medical devices are defined and regulated as drugs.