1 new guideline and 40 new industry standards have been released by CFDA from April 1st. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. If you need any detailed information regarding these guidelines and how they impact your devices in China, please contact us at info@ChinaMedDevice.com.
1. On April 1st, CFDA issued a technical review guideline on Fetal chromosomal aneuploidy (T21, T18, T13) detection kit (high throughput sequencing).
It is class III with class code 6840.
This guideline applies to Fetal Chromosomal Aneuploidies. Fetal chromosomal aneuploidy (T21, T18, T13) detection kit (high throughput sequencing) detect fetal free DNA in maternal peripheral blood plasma, used for prenatal screening of trisomy 21- syndrome, trisomy 18- syndrome and trisomy 13- syndrome.
2. On April 1st, CFDA issues 40 industry standards for medical devices
CFDA recently issued the No. 38 Announcement of 2017, which released 40 industry standards for medical devices, including YY/T 0127.7—2017 “Biological evaluation of dental materials—Part 7: Biological evaluation test method of dental materials—Pulp and dentine usage test” etc. These new standards will be implemented as of April 1, 2018.
CMD helps U.S. medtech companies tap into the medical device market in China. Along with regulatory assistance, CMD helps its clients accelerate China entry and growth, by offering: market Intelligence and research; clinical study and trial design management; distribution qualification and management; and partnership and strategic funding guidance.
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