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When medical device companies sell medical devices in the United States, they must comply with the corresponding quality system requirements, namely 21 CFR 820 (or QSR, Quality System Regulation for short). The U.S. Food and Drug Administration FDA will review medical device companies in and outside the United States from time to time in accordance with the requirements of 21 CFR 820. If a non-conformity is found, a warning letter will be issued.
Many domestic companies in China meet the requirements of the ISO 13485 quality system, but suffer from the need to comply with the 21 CFR 820 regulations of the US FDA. In recent years, the industry has increasingly demanded that the US FDA gradually accept and move closer to ISO 13485. In the near future, the FDA will begin a new plan to open the door to ISO 13485.
The U.S. Food and Drug Administration FDA will implement a new pilot program in June 2012. This program is designed to allow medical device manufacturers to have the opportunity to obtain a one-time review after submitting the ISO13485:2003 quality system audit results to the U.S. FDA. The United States FDA 21 CRF 820 quality system inspection exemption.
Any medical device manufacturer within or outside the United States can participate in the pilot program and submit the audit results to the FDA within 90 days of obtaining the ISO 13485 audit results. In addition, the audit report issued by the ISO 13485 auditor to the medical device manufacturer must meet the requirements of the GHTF founding member regulations. If the US FDA reviewer believes that the ISO 13485 audit report is acceptable, the FDA will allow the manufacturer to be removed from the US FDA's routine inspection list within one year from the date of the most recent ISO 13485 audit under this pilot plan.
As a manufacturer and supplier of non-woven medical products, Hefei C&P is committed to product quality. Our disposable medical products have passed CE and ISO13485 certification and comply with EN13795 and FDA standards, providing you with a safe and reliable guarantee.