Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref. ： EIC 631/2/5

15 February 2016

Dear Sirs,

Commercial Information Circular No. 177/2016

The Mainland of China : Notice Concerning Issues on the Implementation of the "Good Manufacturing Practice for Medical Devices" by the Production Enterprises of Medical Devices (Category 3)

The China Food and Drug Administration issued on 3 February 2016 a notice concerning issues on the implementation of the "Good Manufacturing Practice for Medical Devices" by the production enterprises of medical devices (category 3). Please refer to the Appendix (pdf format) for the notice (available in Chinese only).

2.The "Notice Concerning Issues on the Implementation of the 'Good Manufacturing Practice for Medical Devices'" (available in Chinese only) is available at the following website: http://www.sda.gov.cn/WS01/CL1428/106114.html. For details of the "Good Manufacturing Practice for Medical Devices", please refer to CIC No. 74/2015 dated 20 January 2015.

ENQUIRIES

3.If you have any questions on the content of the document mentioned in this circular, please contact the issuing authority of the Mainland of China direct. For other questions on this circular, please contact Mainland Branch (I) (tel: 2398 5444) of the Department.

Yours faithfully,
 

(Miss Bonny CHAO)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.