During the meeting, MITA called on Chinese officials to include medical devices in the 2013 US - China remanufacturing dialogue, and it was announced that SFDA recently published a list of down classified X-ray products as part of their 2011 JCCT commitments.
In addition to emphasizing the importance of a joint review mechanism for combination products based on the primary mode of action, AdvaMed described the benefits of moving certain in-vitro diagnostic devices into lower-risk categories for regulatory purposes. "Currently, China classifies many in-vitro diagnostics as higher-risk devices than other major medical device markets, which slows patient access to the most advanced diagnostic technologies," said Nancy Travis, AdvaMed vice president of global strategy and analysis.
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AdvaMed also emphasized the importance of following Global Harmonization Task Force guidance that recommends acceptance of a broad range of clinical evidence in the registration process and to avoid mandating clinical trials for any group of medical devices. SFDA welcomed these suggestions as well as U.S. industry's proposal to conduct an information exchange program on clinical evidence.
"We have made incredible progress over the past three days that will benefit members of both our associations, the larger global medical device manufacturing community and most importantly, patients who benefit from our technologies," said Davey Han, MITA's China representative.
For more information on MITA and AdvaMed's international efforts, please visit: http://medicalimaging.org and http://www.advamed.org.
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The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
PRESS CONTACTS:
Rachel Ryan (MITA)
rryan@powelltate.com
202.585.2055
Ashley McMaster (AdvaMed)
AMcmaster@AdvaMed.org
202.434.7245
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