UL LLC

China Stiffens Software Requirements for Medical Devices

UL LLC

How do the latest requirements affect your business?

In August this year, the China Food and Drug Administration (CFDA) announced the release of 2015 Order No. 50, providing guidance for medical device software, including Off-The-Shelf (OTS) used in medical devices, stand alone, or proprietary.

We are excited to share with you the completion of our latest article “Big Changes for CFDA Software Requirements” written by UL Technical Consultant Manager, Tim Lin, out of Taiwan.

Mr. Lin formerly worked for the Taiwan Food and Drug Administration and currently supports UL customers by sharing his expertise in local regulations and with global regulatory submissions.

Click here to read more and download the article.

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