Full article reprinted from "The Gray Sheet" - September 22, 2008
Find out how Chinese approval time for imported medical devices could be cut in half under an agreement to reduce redundancies between the country's Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and its State Food and Drug Administration (SFDA).
Full article reprinted from "The Gray Sheet" - September 22, 2008
Chinese approval time for imported medical devices could be cut in half under an agreement to reduce redundancies between the country's Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and its State Food and Drug Administration (SFDA).
In a Sept. 16 announcement, the Chinese national agencies said they will only require one test, one report, one fee and one factory inspection for medical devices, according to the U.S.-China Joint Commission on Commerce and Trade.
Under previous Chinese law both SFDA and AQSIQ had their own separate registration processes for medical devices, Nancy Travis, VP of global analysis and strategy for AdvaMed, told "The Gray Sheet." As part of that registration process, product tests had to be done in both SFDA and AQSIQ test labs, and factory inspections had to be performed by teams from both agencies.
Chinese regulations that require product testing and factory inspection for registration affect both imported products as well as domestically produced products, "but this elimination of the redundancies seems to only apply to imported medical devices," Travis noted.
All medical devices imported into China as well as Class III products manufactured in China must be approved at the national level, while locally produced Class I and Class II products are approved at the provincial level.
"Right now there's a huge backlog of product registration approvals at the national level, while at the provincial level [where workload is presumably less] they have been much more quick to approve products," Travis said, "so as a practical matter, the imported medical devices are the ones that have really run into a problem with these delays due to the resource constraints" 1("The Gray Sheet" April 28, 2008, p. 3).
One Set Of Product Tests
While AQSIQ and SFDA tests and inspections were previously the same in practice, "they were being done twice, so it was redundant," Travis noted.
Also, prior to the agreement, companies had to submit product samples to two different labs consecutively rather than simultaneously - first to an SFDA test lab, then to an AQSIQ test lab - after which the firms waited for separate reports from each lab, she said.
"Now what's going to happen is they just go to one or the other lab," Travis said.
SFDA and AQSIQ have further agreed to use the same format for their test reports, which will allow test labs to only have to produce one report for both agencies, she added.
"Public Announcement No. 94 of 2008: Public Announcement on Issues Concerning Market Access for Certain Imported Medical Devices," as the agreement is called, is accompanied by a list of test labs where companies can have all their testing done at one time, a convenience expected to save companies a lot of time, according to Travis.
Having one lab perform tests on a product will cut down on confusion, too. "A lot of times there would be kind of a back-and-forth and discussion between the labs on how to do the tests and sometimes the results were unclear," Travis said.
U.S. Companies Will Save By Paying Only Once
In addition to saving time, consolidating product testing at one lab will save companies money because they will not be billed separate fees by different test labs.
It is unclear, however, whether that fee is associated with the test or if it is an overall registration fee, though previous discussions between SFDA, AQSIQ and the U.S. government indicate the agencies are most likely referring to the test fee, Travis said. AdvaMed plans to clarify this point during a November meeting with Chinese officials.
The testing agreement actually was reached last year, according to Travis, but in the interim, in many cases, while only one test lab was involved, it would still issue two test reports and still charge two fees for those reports.
Now, under the agreement, companies that have succeeded in getting the test done at one lab will only have to produce one test report and be charged one fee, according to Travis.
One-Time Factory Inspections
SFDA and AQSIQ have also now consolidated the quality systems inspection process. "What had been happening," said Travis, "is that SFDA would send a team of inspectors out to do the factory inspection, and then AQSIQ would also send its own team out to inspect. We had reports from some companies that these teams would come within just a few months of one another and they would do pretty much the same exact inspection."
Travis noted, however, that the agencies' announcement states that while SFDA has agreed to accept an inspection from AQSIQ in lieu of performing its own audit, "it does not look like AQSIQ will be accepting reports from SFDA."
This could be because AQSIQ has a very large, experienced inspection staff and tends to perform inspections on time every five years, compared to SFDA, which does not always complete its inspections on schedule, according to reports from U.S. device companies.
"So this may just have been a practical issue that AQSIQ is better staffed to do inspections [because] in many cases there is an AQSIQ report available, whereas that's not always true for SFDA," Travis conjectured.
"I don't have any input as to why that particular decision was made," she added. She said AdvaMed hopes to clarify this issue in its November meeting with Chinese officials.
"The next step is really going to be to see how the test labs and how the inspection team implement [the agreement], so some more discussions may need to be held to figure out the details of implementation," she noted.
- Ingrid Mezo
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