News

15 Jun

Is it a good news that the medical device testing fees would be eliminated in China?

All the medical devices require local testing in China for CFDA registration, which is generally done in a CFDA-accredited lab. Recently, the Ministry of Finance of China has released a notice to eliminate several items of fees charged by the authorities (Finance Tax [2017] No. 20), including the certification fees for drug good manufacturing practice (GMP) and drug Good Supply Practice (GSP), as well as the testing fees for both drugs and medical devices. This notice became effective since April 1st, 2017.

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14 Jun

CFDA is planning to down-size the number of categories for medical devices

The China Food and Drug Administration (CFDA) has been using the four-digits category system for medical device since the year of 2000. Currently, all medical devices are divided into 43 categories from “6801” to “68xx”. The category information is embedded in the CFDA certification number as the second and third digits. For example, a certificate of 2016-3642017 shows the product is in the category of 6864 Medical sanitation material and dressing.

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19 May
19 May
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