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.
Contributing to public anxiety is a high-profile case that went to court in Shanghai, where a couple is suing a hospital after their 13-year-old son was allegedly implanted with an unregistered, imported ventricular assist device. A year later, after a second surgery, the child died.
AQSIQ officials have expressed concerns publicly about "too many devices utilizing foreign specifications and poor labeling for use by Chinese doctors and patients," reported Beijing-based attorney Chen Yang and Washington, D.C.-based Sidley Austin colleague Scott Bass in August in 1PharmAsia News.
China Reg Is Too Stringent, Says WTO Delegation
U.S. officials, however, say Decree 95 goes too far.
A communication sent Oct. 22 from the U.S. WTO delegation to the Chinese government describes the requirements as going "substantially further than common international practice, where border inspection is generally done only on a very small percentage of already-certified devices, and done in response to targeted concerns."
The memo asks the government to clarify how the rule will be implemented and to hold off on adopting the measure until WTO members can present detailed written comments.
The trade officials also want China to justify why it did not notify the WTO before issuing the rule.
"We are anticipating boxes and boxes of medical devices would be piling up at the borders of China" if Decree 95 goes through as written, said AdvaMed's Nancy Travis, VP of global strategy and analysis, in an interview.
The regulation would establish a matrix of three device risk categories and three reliability levels for importing companies based on the number of customer complaints and product recalls.
From 10% to 100% of imported products might be inspected, depending on the designated risk category of the device type under the pending rule. Devices in the highest risk category, including MRIs and pacemakers, would undergo inspection 100% of the time, according to the U.S. WTO delegation.
The intensity and type of inspection will vary based on the category of the importer and the device.
Industry Seeks Six Month Implementation Delay
AdvaMed is working with the American Chamber of Commerce in China in an attempt to convince AQSIQ to delay implementation for at least six months.
The trade group has received some informal communications from AQSIQ officials that they are considering a delay past Dec. 1, but "they say that it needs to be approved at the higher ministerial level so we're still waiting to hear something definitive," Travis noted.
AdvaMed is concerned that the AQSIQ reg will duplicate checks already in place by China's State Food and Drug Administration (SFDA), which has primary authority over medical devices in the country. SFDA requires a registration process including product sample testing by government officials.
AQSIQ currently oversees the importation of certain devices that have electrical components, but Travis said the role of AQSIQ right now is "very limited." According to a survey of AdvaMed members, pacemakers are the only products that are subject to an import inspection beyond standard paperwork review.
Expanding that practice to a more comprehensive set of devices brings up a lot of questions, she said.
"Sometimes, the Chinese, when they talk about inspections, they really mean tests, which could be destructive tests where they're removing it from the package," Travis noted.
"That obviously would be impracticable for 100% of inspections, so there's a range of issues that it seems to us that the AQSIQ has not really considered, based in part on the special nature of our products."
China border officials currently inspect pacemakers in a manner that is not destructive, but is essentially a waste of time, according to Travis.
By her account, the inspectors rely on a device used by hospitals to check the settings of a pacemaker, but use it to sweep the box containing the device.
"This checks whether the factory settings are valid, which doesn't really tell you anything," Travis said. "In our view, it doesn't add any kind of safety, and it really just creates delays at the border." She says that pacemakers sit in a factory holding area for 10 days on average while awaiting the inspection.
It is unclear how customs inspectors would examine products like orthopedic implants, or heart valves, or any other items that are packaged in sterile packaging, she pointed out.
Another area of uncertainty relates to product categorizations. The pending rule says AQSIQ will publish a catalogue that sets risk categories for the different products, but "it's unclear the criteria that's going to be used for that," Travis said.
The law's categorization of companies based on their reliability is even more troubling to industry.
"As it's written, there would be no medical device company in the world that would be able to be in the most reliable category," Travis noted. "One of the categories is that [a company] can have no customer complaints, and we don't know any companies like that."
SFDA Also Seeks Strengthened Authority
In the mix of concerns over the impending AQSIQ regulations, the U.S. device industry is also dealing with a couple of other China policies in the works that they say could cause significant market barriers.
China's National Development & Reform Commission is circulating a draft rule that would place more restrictions on device pricing (2"The Gray Sheet" Oct. 22, 2007, p. 8).
Meanwhile, SFDA is looking to enhance its own oversight of devices in response to product safety anxieties within the country and internationally about products exported from China.
At an Aug. 8 press conference, an SFDA spokesperson announced the development of a revised regulation to intensify device regulations for both imports and exports, reports PharmAsia News.
The agency said it would perform a six-month campaign of special inspections of licenses for imported devices. It also plans to step up inspections of manufacturer facilities.
AdvaMed confirms it recently received an invitation to comment on a pending Chinese regulation that Travis says significantly revises current SFDA device rules and includes a section on import inspections.
"It does raise an additional concern," she said. "If both [the AQSIQ and SFDA rules] are implemented, we'll be facing two import inspection regimes that are inappropriate."
[Editors Note: Additional coverage of Asia is provided at PharmAsia News, F-D-C Reports' new beta site for Asian medical product news. To register for complementary e-mail updates, visit www.pharmasianews.com.]
- Ingrid Mezo
