Home Privacy statement

Promise
Chindex Medical Limited is committed to protecting your private information and data provided when you use our website, enabling the collection, utilization, storage and transmission of private information and date to be in accordance with the relevant standard of laws and regulations.

Please read carefully and understand this privacy statement. Once you use our site, you will be deemed to have accepted, agreed, committed, and confirmed the contents of this privacy statement.

Personal Information
You can access our website and get information under the anonymous status. In order to understand your requirements better and to provide you with better services, please understand that some information and services may only be provided after your registration. The personal information that we need to collect include your name, address, phone number or e-mail address etc., hereinafter collectively referred to as "personal information".

If you wish to use the services only provided after your registration, you should agree with the following issues: you have to provide according to the prompts of the registration form of the service, the true, accurate, latest, and complete information and to update the registered information promptly. If you provide any error, fake, outdated, incomplete or misleading information, or if we have reason to suspect the aforementioned information to be error, fake, outdated, incomplete or misleading, we are entitled to suspend or terminate your account, and to refuse you to use any or all of the services provided by our website.

Purpose of use
Principally, the purpose of using your personal information is limited to the scope of which have been notified in advance. If we intend to use your personal information out of the scope of the specified purpose, we will inform you the new purpose in advance. You may refuse according to your own judgment if you do not agree to the use of your personal information for the new purposes.

Restrictions on purposes of use
We will take reasonable security measures to safeguard your registered personal information. Unless required by the mandatory laws or government regulations, Chindex Medical Limited will not expose any of your personal information that is collected through our website to any unrelated third party (including companies and individuals) without obtaining your prior permission.

You should be aware: our website may open the personal information when required by the law, or believe in good faith that it is necessary to the following items:

01. To comply with the legal notices or the legal procedures of Chindex Medical Limited.

02. To protect the rights and properties of the users of our website.

03. To safeguard the website and its users under emergency circumstance.

Non-Personal Information
We will collect non-personal information through user’s IP address such as the type of browser and operating system, and the name of ISP providing the access service etc, to optimize the interface displayed on your PC screen; and to calculate the guest flow through collecting these information. These non-personal information help us to identify the regional distribution of preferred content, to ensure the effectiveness of the promotions, and to help us improve the property and content of our website.
Linking to the other sites
We provide links to other web sites for your convenience and information. These sites may have their own privacy statements, we recommend you to review before you browse these sites for the sake of your interests. Chindex Medical Limited is not responsible for the contents or any operations of these linked sites.
Privacy of minors
Chindex Medical Limited cares about the safety and privacy of all users, especially minor users. We will not collect personal information of minors without obtaining permissions from the guardians of the minors according to the law. We only collect information of minors after obtaining permissions from the guardians of the minors within the scope of the law. Chindex Medical Limited will build and maintain thorough and reasonable programs to safeguard privacy and security of personal information of minors.
Changes on Privacy Statement
This Privacy Statement may be updated periodically. If we make any modifications, we will notice you on the bulletin board so that the users could know the type of content modified, and could review the updated Privacy Statement. You are deemed to agree to comply with such modifications if you continue to use our site after release of any of the modifications.

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.