What changes have taken place in China’s medical device registration management system?
01
The Changes in management methods of class I medical devices
As is known to all, China implements classified management of medical devices according to the level of risk. The 2000 edition of the Regulations carried out unified registration management for all categories of medical devices, and the 2014 revised Regulations has changed class I medical devices to filing management.The original intention of this reform is to implements the concept of risk management and improves the efficiency of supervision.
It simplifies the registration procedure of the class I medical device, which is a great progress in China’s medical device registration management system.
02
The emergence of medical device renewal registration
The 2014 version of the regulations distinguishes between renewal of registration and re-registration, replacing re-registration with renewal of registration. Renewal registration means that when the registration certificate of a medical device is about to expire, the registrant can submit declaration materials to the relevant departments and apply for renewal of the registration certificate.It can be seen that the effectiveness and validity of the registration certificate have been extended, but there is no substantial change in the structural characteristics and technical principles of the product corresponding to the registration certificate, which is also the basic starting point for the renewal of registration.Re-registration requires that no matter whether the product has changed substantially or not, as long as the certificate expires, it needs to go back to the registration process.
03
Changes in the registration management of innovative medical devices
In 2014, the State Drug Administration has issued and implemented the “Special examination and approval procedure for innovative Medical Devices (trial)” (hereinafter referred to as “Special examination and approval procedure (trial)”), which proposed special approval for innovative medical devices for the first time.
A. For products that have been granted the patent right for invention or the right to use it in China in accordance with the law, it is required that the application time for special examination of innovative medical devices shall not exceed 5 years from the date of patent authorization announcement.
B.For products whose applications for patents for core technological inventions have been made public by the patent administration department under the State Council, a search report is required by the Patent Retrieval and consultation Center of the State Intellectual Property Office, which states that the core technology plan of the product is novel and creative.The promulgation of the “Special Examination and Approval Procedure (trial)” is equivalent to opening up a “shortcut” for innovative medical device registration, which is conducive to promoting the promotion and application of new medical device technology.b.
In addition, the “Special Examination and Approval Procedure (trial)” is only a normative document of government departments. Compared with the laws related to the innovation plan in the United States, China’s medical device innovation policy should strengthen the protection of innovation action.
04
Emergency approval and priority approval of medical devices
“The Emergency examination and approval procedure for Medical Devices” issued in 2009 strengthens the response to public health emergencies, which provides a legal basis for the examination and approval of medical device in emergency situations.On this basis, in 2016, China issued the “priority examination and approval procedure for Medical Devices”. Priority examination and approval shall be given to medical devices for the treatment of rare diseases, malignant tumors, geriatric diseases and children, clinical urgent needs, and listed in national major scientific and technological special projects or key R & D plans.The release and implementation of “The Emergency Examination and Approval Procedure for Medical Devices“ and “Medical Device Priority Examination and Approval Procedure” have further improved China’s medical device registration management system, which is of great benefit to deepening the reform of medical device examination and approval and ensuring the demand for clinical use of medical devices.
05
The Registrants must assume legal responsibility for the quality of the product throughout their life cycle
On June 1, 2021,the newly revised “Regulations on the Supervision and Administration of Medical Devices” has been formally implemented.
In the future,the registrants must assume legal responsibility for the quality of the product throughout their life cycle,and each medical device will have a unique “Electronic ID Card” for traceability management.
According to the regulation， the so-called “Heavy Penalty” refers to the maximum penalty of 30 times of the value of goods for illegal acts involving quality and safety.At the same time, according to the circumstances of the violation, the offender shall be punished with the revocation of the license, the prohibition of related activities for a certain period of time, and the failure to accept the relevant license application.In addition, the regulations also increase the “Punishment to People” measures, and punish the relevant responsible personnel of serious illegal units with confiscation of income, fine, five years or even life-long prohibition of relevant activities.
New regulation also aims to encourage innovation and promote high-quality industrial development. These include measures to implement informative filing and encourage medical institutions to carry out clinical trials.For example, for low-risk medical devices, informed filing is implemented, and the filing is completed after the filing person submits the information that meets the requirements.
For more information about China’s policy on medical device registration,please contact info@inspirativemed.com
