China: China Overhauls Regulation On The Medical Device Industry

Last Updated: 29 May 2014
Article by David J.D. Dai, Teresa Lou and Bryan Fu

The Chinese Central Government recently adopted material amendments to the Regulation on the Supervision and Administration of Medical Devices, which will bring significant changes for medical device companies operating in China.

On 31 March 2014, the State Council of the Chinese Central Government unveiled a revised Regulation on the Supervision and Administration of Medical Devices (Revised Regulation).  The Revised Regulation will come into effect on 1 June 2014 and replace the previous Regulation on the Supervision and Administration of Medical Devices issued by the Chinese government in 2000 (Original Regulation).  As a result of the rapid growth of the Chinese medical devices industry, the Original Regulation is no longer effective in addressing issues in the industry. 

The Revised Regulation is the first significant legislation issued by the Chinese Government in 14 years aimed at overhauling the regulatory framework governing the industry in order to keep up with the fast-changing medical devices industry and to enhance the protection of public health.  The Revised Regulation therefore contains overarching changes that will affect all market players throughout the medical device lifecycle, from product approval through distribution and use.  The main changes in the Revised Regulation are as follows.

Liberalisation in Product Approval & Registration

Consistent with the goal of China's 12th Five-Year Plan to foster innovation and encourage the development of domestic intellectual property by Chinese companies, the Revised Regulation introduces a number of new policies directed at optimizing and streamlining the review and approval process for marketing medical devices, thus lessening the burden of companies seeking pre-marketing approvals for their medical devices.

The Original Regulation required that registration certificates be obtained from the China Food and Drug Administration (CFDA) or its local offices for all medical devices—regardless of whether it was a Class I, Class II or Class III product—before the devices could be marketed in China.  Under the Revised Regulation, no registration certificate is required for Class I medical devices, whether they are imported or manufactured in China.  Instead a filing with CFDA or its local offices will suffice.

The Revised Regulation also provides that if the changes to registered medical devices within Class II and Class III are not substantial, and do not affect the safety and effectiveness of such products, the changes only need to be filed with CFDA.  In addition, the prior requirement for registration change approval under the Original Regulation is no longer necessary.

The Revised Regulation further eliminates the clinical trial approval required under the Original Regulation for medical devices falling within Class II, and only requires a filing of the clinical trial with CFDA authorities.  Clinical trials can also be exempted for medical devices falling within Class II and Class III in certain circumstances where the safety and effectiveness of the products can be demonstrated by other measures such as non-clinical evaluation or data from clinical trials of similar types of medical devices.  CFDA will publish and maintain a list of medical devices exempted from clinical trials. 

Improved Supervision on Production

For medical devices falling within Class II and Class III, CFDA no longer requires a company to obtain a production permit (Production Permit) before it can apply for a product registration certificate. Instead, the Revised Regulation requires a company to submit the product registration certificate when applying for the Production Permit of such a product. This reform may relieve the financial pressure on medical device companies as they can apply for a product registration certificate before they need to invest funds to build the production facilities to obtain the Production Permit.

For medical devices falling within Class I, the Revised Regulation allows manufacturers to file for record at the city level (i.e., cities with districts) rather than at the provincial level under the Original Regulation.  The Revised Regulation iterates the requirement that medical device enterprises must implement and strengthen a comprehensive quality management system.  In addition, self-audit reports on the implementation of such a system are required to be filed with local CFDA authorities on a regular basis.

The Revised Regulation also sets out a detailed list of items that must be included in the user manual and on the labels of medical devices.  The list had previously been set out in rules issued by CFDA in 2004 governing user manual, labeling and packaging.

Under the Revised Regulation, an entrusted production (similar to OEM) is not allowed for high-risk medical devices designed for implantation in the body.  The detailed list of such devices will be promulgated by CFDA in the future.

Reformed Regulation in Distribution and Use

The Original Regulation required companies distributing Class I medical devices to file for record with CFDA authorities, and companies distributing Class II medical devices to obtain a license from CFDA.  The Revised Regulation removes the filing requirement for Class I medical device distributors and only requires Class II medical device distributors to file with CFDA at the municipal level. 

The Original Regulation contained only a few simple provisions setting forth the use of medical devices.  The Revised Regulation places more obligations on medical institutions using medical devices.  Such obligations cover all aspects of use of the medical device including storage, records of purchase, personnel training, and maintenance and use records for large medical devices that have long shelf lives.

The medical institutions using medical devices shall establish policies for purchase, inspection and recording of such purchase and inspection.  Companies engaged in wholesaling Class II and III medical devices and companies retailing Class III medical devices must establish sale recording policies. 

Tightened Post-marketing Supervision & Liabilities

The Revised Regulation enhances post-marketing supervision by enacting provisions to establish mechanisms for adverse event monitoring, re-evaluating registered products and product recalls.  Such provisions aim to effectively identify problematic medical devices in the market and provide statutory remedies to stop the manufacturing, sales, distribution and use of unsafe medical devices in the market.

While the Original Regulation was silent about the above mechanisms, the State Administration of Food and Drugs (the predecessor of CFDA) and the Ministry of Health (MOH) issued joint pilot regulations on adverse event monitoring and re-evaluating medical devices in 2008.  In addition, MOH also issued the Provisional Administrative Measures on the Recall of Defective Medical Devices in 2011.  The Revised Regulation officially endorses the above mechanisms and further stresses the interactions between these three mechanisms.  For example, CFDA's provincial office may re-evaluate any defective medical devices identified by the adverse monitoring system, and as an additional remedy institute a mandatory product recall for such defective medical device products.

The Revised Regulation further strengthens CFDA's ability to conduct routine supervision over all players in this industry, and focus its monitoring on the manufacturing, quality management and operational conditions of manufacturers and distributors.  Meanwhile, the Revised Regulation expressly authorises CFDA authorities to exercise the following statutory powers:

  • Carry out on-site random sampling and inspection
  • Review, copy, attach and seize contracts, invoices, accounts and other related documents relevant to their ability to conduct inspections
  • Seize or attach products that are not consistent with statutory requirements, problematic raw materials, auxiliary materials, and tools and equipment used in unlawful productions
  • Shut down production or operation premises carrying out non-compliant activities

In addition, the Revised Regulation further specifies the administrative sanctions corresponding to the statutory obligations imposed therein.  New administrative sanctions have been enacted to target various violations, and even heavier sanctions have been included to target material violations.  For example, administrative penalties up to 20 times the value of the products manufactured may be imposed on medical devices produced without proper permits.  Moreover, the manufacturer and its persons-in-charge will be barred from applying for any new licenses or permits in this industry for five years in "severe circumstances", and may be subject to criminal sanctions if such violation constitutes criminal offenses. 


The changes made in the Revised Regulation demonstrate the Chinese Central Government's new efforts to upgrade and maintain a comprehensive and effective regulatory framework for the medical devices industry in China.  On the same day the Revised Regulation was released, CFDA sought public comments on a number of related draft rules covering medical device registration and filing, manufacturing and distribution.  Moreover, CFDA has also published over the past months various draft rules governing products classification, inspection criteria for GMP (Good Manufacturing Practice), GSP (Good Supply Practice) for distributors and amendments for a number of product categories.  It is anticipated that the official promulgation of these rules will facilitate the enforcement of the Revised Regulation.  

Medical device companies doing business in China should keep a close watch on the development of the draft rules and the actual enforcement of the Revised Regulation because the changes will have significant implications on their operations in China.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions