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.
The dialogue comes not only in the midst of high-profile complaints about Chinese exports to the U.S., but also growing domestic concerns about product safety within China (1"The Gray Sheet" Nov. 5, 2007, p. 3).
The Chinese government has made efforts to increase its oversight of medical devices including a new SFDA regulation issued last year to gain better control of both imported and exported devices. In March, SFDA proposed its first system for recalling medical devices on the Chinese market (2"The Gray Sheet" April 7, 2008, p. 11).
U.S. negotiators late last year convinced another Chinese government agency, the General Administration of Quality, Supervision and Quarantine (AQSIQ), to abandon a proposal that would have subjected up to 100% of certain imported implantable devices to physical inspection or laboratory testing at China's border.
During this month's talks, the U.S. delegation pressed for reconsideration of other current or proposed regulatory policies.
According to Travis, SFDA's new device regulations include a similar requirement to AQSIQ's border inspection proposal. Industry complains that such individual product inspection mandates are unworkable because the inspections in many cases can actually destroy the devices and cause big delays in getting foreign-manufactured products onto the Chinese market.
"So we asked them to remove those and they for the most part agree that border inspections are not necessary for medical devices," Travis said. Nonetheless, "they seem to be reserving the right to inspect implantable and high-risk medical devices, and that is something that we disagree with."
From Product Testing To Quality Management
China's focus on requiring device testing in government labs, which is an established part of the country's product registration process, was a main source of debate during the device task force meetings.
U.S. reps presented as an alternative the U.S./European-style quality systems management philosophy, where regulatory standards are established for device design control, safety complaint response, manufacturer-performed quality control testing and other activities.
"China's position is that it still feels like it needs to do product testing mainly to provide [controls for] manufacturers who do not yet have adequate quality control systems in place," Travis said.
SFDA officials she met with, though, are increasingly open to the possibility of exploring a quality system approach, she noted. The government has shifted away from bench testing of lower-risk products. And U.S. industry reps now are working with Chinese regulators to develop a section in SFDA device regulations that would start a transition to a quality management approach.
Under the transitional approach, manufacturers would audit their factories as they develop products. But the Chinese regulatory authority would still be able to perform product testing when it feels it is necessary to ensure safety.
This approach "could halve their testing requirements," Travis pointed out. Ultimately, "we are working with them [to] have their testing requirements phased out."
Re-registration Will Be Easier In Some Cases
The most tangible concession gained from SFDA during the April talks will make it less burdensome in some cases for manufacturers to re-register devices on the Chinese market.
Under China's current system, if manufacturers have to make any form of change, from a design adjustment to product labeling revisions to updating the company address, the device "basically goes through the full registration process all over again, including the product testing," Travis said. Manufacturers are also required to re-register their products every four years even if changes are not made.
Chinese officials agreed that products with minor changes or no changes do not need to go through the full re-registration process and will not be put through retesting. Changes deemed "major" are still subject to the testing requirement, Travis said.
Country Of Origin Requirement Remains
SFDA would not budge on its requirement that a product be approved in the country where it is manufactured, or in its country of origin, before it is granted approval in China.
This means that if a U.S. manufacturer submits marketing approval applications in both the U.S. and Europe, for example, and the product is CE marked in Europe before the FDA approves it, the manufacturer has to wait for U.S. approval before China will even review a marketing application.
"We think that that's not appropriate and fair, so we asked China to review that requirement," Travis said.
SFDA officials say that their system has still not developed to the point of being able to independently affirm a product's safety. Travis said U.S. trade reps are attempting to make the case for reviewing products that have been approved by at least one regulatory agency even if it is not the country of origin.
By a strict interpretation of the current law, a manufacturer might be forced to seek an approval in a country where a product is manufactured but is not the intended market, Travis claims. For instance, if a product is manufactured in Mexico for other markets, a firm might need to "have the product for sale in Mexico before you could submit it for approval in China."
As it stands, SFDA has a backlog of 6,000 products accepted for review waiting to be approved, according to Travis. "In some cases it goes back and year-and-a half, and in some cases we may already have [updated] products coming on the market before they're approved in China."
U.S. manufacturers are more affected than Chinese manufacturers because lower risk class I and II devices offered by domestic firms are reviewed by provincial branches of China's regulatory agency, while all class III devices and all imported devices are reviewed by the national agency.
SFDA officials revealed during the task force meeting that it has recently added 20 new reviewers to a staff of 15. The agency says it plans to bring in another 15 reviewers and has established a training program for new staffers.
U.S. trade reps recommended SFDA employ a triage approach to device reviews to make the process more efficient, Travis said. They also pushed for a more open dialogue between Chinese reviewers and foreign device manufacturers to resolve minor problems more quickly.
Travis pointed to an example where a company based in Minneapolis abbreviated the word "Minnesota" on the second page of its application.
"They filled out the full address on the first page, and that was sent back as an incomplete application," she explained. "So sometimes they are very minor issues that are causing these applications to be kicked back."
"We view [the staff increases] as very positive measures to reduce the backlog, but it still is a very big problem," Travis said.
[Editor's note: Additional coverage of Asian markets is provided at 3PharmAsia News, F-D-C Reports' Web site for Asian biotech, pharmaceutical and medical device news. 4Sign up now for a no-risk, 30-day trial subscription at 5www.pharmasianews.com.]
- Ingrid Mezo
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