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Prohibition
No infringement of the rights of the property and privacy of CML or any other party is allowed when using this website. Do not conduct or attempt to conduct any behavior in any manner that may interrupt the normal operation of this website.

Copyright
All contents of this website and the copyright thereof belong to CML. This website and all relevant contents are protected by international common laws on copyright and other relevant requirements. Without written permission of CML, no materials on this website shall be used.

Disclaimer
There may be omission or inaccuracy of the materials on this website or negligence in the layout. You shall bear the responsibility of any risk arising from the reliance on any advice, views, statements or information provided on this website.CML do not assume any liability arising from the above matters.CML shall reserve the right to modify the contents, in part or in whole, of this website (including the terms set out in this notice) anytime without notification. CML shall have the right to terminate or suspend the provision of certain contents, in part or in whole, of the website anytime.

Legal Jurisdiction
This website is managed and maintained by the administration department of CML in The People's Republic of China. These Terms of Use shall be executed in accordance with relevant laws of The People's Republic of China. Any legal action against the use of this website must be taken within one year when the disclaimer is made or the grounds to take legal actions occurred.

F A Q

Is it legal for manufacturers to cope with issues of initial registration without an agent ?

Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.

In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?

Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.

How long is the NMPA review process for the initial registration of the medical device ?

After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.

Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?

MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.