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China Med Device, LLC
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In One Day, 17 Industry Standards Released by CFDA
Sterilization of infusion device, biological testing, and standardization of medical consumables are covered.
https://chinameddevice.com/in-one-day-17-industry-standards-released-by-cfda/
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Major Leadership Demotion at CFDA Today
It shows the difference of post-market responsibilities by the regulatory key people between US and China.
https://chinameddevice.com/major-leadership-demotion-at-cfda-today/
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Huge growth room for combination device in China as the first batch of approved products was just released a year ago.
https://chinameddevice.com/introduction-of-cfda-approved-combination-products/
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A month of “recall”: Shanghai Half Year Recall Report issued; 3 ophthalmic devices from Johnson & Johnson recalled in one week.
https://chinameddevice.com/monthly-cfda-news-roundup-july/
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China Counters U.S. Tariff - Time for More Manufacturing Setup in China
The tariff plan became effective yesterday (Aug 8).
https://chinameddevice.com/china-counters-u-s-tariff-time-for-more-manufacturing-setup-in-china/
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CFDA New Medical Device Classification Catalogue Effective August 1st, 2018
Key changes affect the classification of your device.
https://chinameddevice.com/cfda-new-medical-device-classification-catalogue-effective-august-1st-2018/
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Faster and Lower-Cost Entry into China: 4th Batch of Clinical Exemptions Released
It is the first time class III IVDs (31 items) have been exempted.
https://chinameddevice.com/faster-and-lower-cost-entry-into-china-4th-batch-of-clinical-exempted-medical-devicesand-ivds/
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Weekly CFDA News Roundup (July 16th to July 22nd)
Imported medical devices account for 93% of total recalls, showed in Shanghai Recall Report.
https://chinameddevice.com/weekly-cfda-news-roundup-july-16th-to-july-22nd/
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