Home    Terms of use

Terms of Use
1.1 These Terms of Use of Chindex Medical Limited (”CML”) govern the use of the internet pages provided by Chindex Medical Limited and/or its subsidiaries (the "CML Website"). Any use of the CML Website is only permitted on the basis of these Terms of Use, which may be amended, modified or replaced by other terms and conditions.
2. Services
2.1 CML offers on the CML Website specific information, software and related documentation, as the case may be, for viewing or downloading.
2.2 CML may at any time cease the operation of the entire CML Website or parts thereof. CML shall not accept any responsibility and shall not be liable for the continuous availability of the CML Website.
3. Rights of Use to Information, Software and Documentation
3.1 Any use of information, software and documentation provided by CML on the CML Website, and of any updates thereof, (the “CML Contents”) shall be subject to these Terms of Use or the applicable license terms agreed with CML, provided that separately agreed license terms shall always prevail over these Terms of Use.
3.2 CML grants the User a non-exclusive and non-transferable right to use the CML Contents to the extent agreed between CML and the User or, if there is no such agreement, in accordance with the purpose obviously intended by CML in making the same available.
4 Intellectual Property
4.1 Notwithstanding the provisions of section 3 of these Terms of Use, any brand names and other CML Contents made available on the CML Website may not be modified, copied, reproduced, sold, rented, supplemented or used in any other way without the prior written permission of CML.
4.2 These Terms of Use shall not confer any rights in copyrights or other intellectual property to the User, including rights in copyrights, brands, patents or utility models, except as expressly granted herein, and there shall be no implied obligation of CML to do so.
5. Duties of the User
5.1 While using the CML Website the User shall not: 
harm or infringe the personal rights of third parties;
breach public morality; 
infringe intellectual property or other proprietary rights;
upload, store or distribute any contents containing malware.
5.2 If the User breaches any obligation arising from these Terms of Use, and without prejudice to any other remedies CML may have, such User will immediately be denied access to the CML Website.
6. Third Party Content
The CML Website may contain hyperlinks to webpages of third parties. CML does not control and shall not assume any responsibility or liability for the contents and information provided on such webpages. In addition, CML does not endorse or make representations with respect to such third party webpages or their contents. The use of such webpages shall be at the sole risk of the User.
7. Quality or title defects
7.1 Any warranties or liability for defects of the CML Contents as to quality or title, express or implied, are excluded, including warranties of correctness, completeness, merchantability and/or fitness for purpose, or of absence of third party rights, except for cases of willful misconduct, fraud, gross negligence, personal injury or death.
7.2 The CML Contents may contain general descriptions of the technical possibilities of individual products which may not be available in certain cases (e.g. due to product changes). Any such descriptions may not be understood as contractual warranties and the User accepts that the required performance of products shall be as agreed at the time of purchase.
8. Other Liability, Viruses
8.1 The liability of CML for defects in relation to quality and title shall be determined in accordance with the provisions of section 7 of these conditions. Any further liability of CML is excluded unless and to the extent required by applicable mandatory law, e.g. in cases of willful misconduct, fraud, gross negligence, personal injury or death, failure to achieve guaranteed characteristics, fraudulent concealment of a defect or in case of breach of fundamental contractual obligations. The damages in case of breach of fundamental contractual obligations is limited to the contract-typical, foreseeable damage if there is no willful misconduct or gross negligence.
8.2 Although CML endeavors to keep the CML Website free from viruses and other malware, CML cannot give any guarantee to this effect. The User shall take all measures required for its own protection to ensure appropriate security and, in particular, use a virus scanner before downloading any CML Contents. In addition, the User shall take reasonable security precautions and, in particular, use a virus scanner before uploading any contents onto the CML Website.

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.