A Big Deal! China's Draft of Outcome Document of Clinical Evaluation Coordination Project Approved by the IMDRF Unanimously!

  • 2019-04-04

On March 19-21, the 15th Management Council meeting of International Medical Device Regulators Forum (IMDRF) was opened in Moscow, Russia. The unanimous approval of Draft of the Outcome Document of Clinical Evaluation Coordination Project ("the Project"), compiled under the leadership of China, marks a smooth progress for the Project to enter into the phase of global public consultation, which means that China's medical device regulation concepts have gained international recognition and China has grown into a leader in the compiling of some international coordinated laws and regulations on medical devices regulating.

The achievement is a trophy for Chinese medical device regulators who have delved into Chinese and foreign regulations on medical devices regulation for many years and applied their great accumulation to the hard compiling work for tens of months. This is also a representative evidence for China's expanding global influence on the medical device regulation.

From a participant to a leader
Established in February 2011 as an intergovernmental international organization participated by medical device regulatory authorities, IMDRF is devoted to accelerating the integration of international medical device regulations and promoting the establishment of better medical device regulatory modes, so as to meet new challenges rising in the industry and safeguard public health and safety for the best. In 2013, China officially joined the IMDRF, which has 10 full members currently, namely the United States, the European Union, Japan, Australia, Canada, Brazil, China, Russia, Singapore and South Korea.

In March 2018, China successfully hosted the 13th IMDRF Management Council Meeting in Shanghai for the first time as the rotating president. At the meeting, China proposed a new project on the clinical evaluation of medical devices which was unanimously supported and approved by the participants. China's national drug regulatory department was selected to be the chairman of the working team on the Project. This is the first time for China to make suggestions for a new project at the meeting as an initiator since joining IMDRF, marking that China's medical device regulators have gradually achieved the role transformation from a participant to a leader of a certain field and China has gradually had a greater say in the international medical device regulation affairs.

It is known that the Project is dedicated to promoting the law-provision integration in various regulatory regions, coordinating the use and review requirements of clinical data, reducing redundant clinical trials and accelerating the timely introducing of new devices in various regulatory regions tapping into the clinical data and real-world evidences of the marketed devices.

Promoting the steady implementation of the Project
CMDE-NMPA is China's responsible department for the implementation of the Clinical Evaluation Coordination Project. In March 2018, CMDE-NMPA has completed the final edition of the suggestions pooled for the new Project in accordance with the opinions of the IMDRF Management Council, specifying that the working team is in an open nature and the industry representatives are welcomed to join in. Later, in the name of the chairman of the working team, CMDE-NMPA issued an official invitation to the members of the IMDRF Management Council and established the IMDRF Project working team, a team consisting of 27 members from 10 member countries, one observer (PAHO) and two international associations.

In order to ensure that the Project is promoted smoothly according to the time schedule, a Chinese working team is also established, of which the members include the CMDE-NMPA clinical trial project working team, some representatives from several medical device enterprises, personals from some regional coordination associations and representatives from relative industrial associations. Three additional research teams are established specializing in three research themes divided for the Project, namely: (1) Decision-making Principles for Clinical Trials of Medical Devices; (2) Basic Requirements for the Product Equality of Application and Comparison in Clinical Evaluation; and (3) Principles for Accepting Overseas Clinical Trial Data. At the same time, a working mechanism is also established featuring backbone leading, enterprise participating and clinical experts supporting.

These efforts, however, are just the first step marched. Having drafted the initial document and working under the authority of the IMDRF working team, the Chinese team went through three rounds of intensive discussion and repeated modification, and solicited and adopted extensive reasonable opinions from the team members and their regulatory authorities by exchanging E-mails, holding telephone meetings as well as organizing face-to-face conferences. Under the joint efforts of all members, the document draft was eventually formed and submitted to the IMDRF Management Council.

Achieving a win-win situation for both the regulators and the industry
With no doubt, the Project has achieved a win-win situation for both the regulators and the industry.
The industry is looking forward to the official releasing of the outcome document after the researches of the Project. In accordance with the IMDRF working mechanism, every member country shall, at proper time, adopt the outcome document formed by the IMDRF to its national laws and regulations. The official releasing of the future outcome document on the Project means that after the clinical evaluation of enterprises is completed in accordance with unified requirements and principles, the results may support the marketing approval of the products in various countries, promising a faster synchronized global marketing of new products, including domestic innovative ones.

The clinical trials of the medical devices often need at least 2-3 years and millions of USD, which is a dear cost and will eventually embody on the product prices. In an interview, Wang Rong said that the outcome document on the Project, once established and used among IMDRF members, will provide better guidance for the enterprises in their production and use of clinical evidence, and promote the industry to adopt international coordinated standards, reduce unnecessary cost of clinical trials and benefit patients with clinical improvements provided by better medical technology.

The outcome document of the Project is expected to be officially released in September this year, and the research results will be incorporated into relevant regulatory laws, regulations and guiding principles.