On December 16, 2017, 2017 Hot Topics Policy Seminar of China Medical Device Industry hosted by China Association for Medical Devices Industry was held in Beijing. The Chinese drug administration session was hosted by Jiang Feng, the executive vice president of the CAMDI and Dr. Fan Xiaodong. President Zhao Yixin, made a welcome speech, and leaders of Center for Medical Device Evaluation, China Food and Drug Administration, Medical Device Registration Division of the CFDA, National Institutes for Food and Drug Control (Medical Device Standard Management Center of the CFDA) attended the meeting. More than 300 business representatives came together to discuss the changes in the policy environment and trends in the medical device industry.
In her speech, President Zhao Yixin mentioned that in recent years, medical devices have become a highly watched industry. Supported by “13th Five Year Plan” and other top-level designs, the medical device industry has got its motive force of growth from the cooperation between relevant ministries. With the unprecedented favorable policy, the medical device industry will enter a high-speed development period.
Zhao Yixin, President of the CAMDI
Jiang Feng, the Standing Vice-Chairman of the CAMDI
Fan Xiaodong, the Standing Vice-Chairman of the CAMDI
Lu Zhong, the deputy director of Center for Medical Device Evaluation, CFDA, made a keynote speech on the reform of Center for Medical Device Evaluation of the CFDA, with a focus on the state’s requirements for deepening the reform and encouraging innovation as well as the reform objectives of the CMDE. Based on the reform projects currently completed by the CMDE, the next step of the CMDE reform was put forward with a focus on deepening the reform of review mechanism, encouraging the innovation of medical device research and development, strengthening the technical support for review and approval and strengthening the information construction of the review and approval of medical devices.
Lu Zhong (Deputy Director of Center for Medical Device Evaluation of the CFDA)
Director Yuan Peng, Medical Device Registration Division 1 of the CFDA made a keynote speech on “deepening the reforms of review and approval and encouraging medical devices”. He briefly introduced the reforms of review and approval of medical devices, mainly interpreting the “Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices” proposed by General Office of the CPC Central Committee and General Office of the State Council of the People’s Republic of China from four perspectives: the acceleration of the review and approval for the commercialization of medical devices, the reform of clinical trial management, the implementation of life cycle management of medical devices, and enhancement of the support ability of review and approval.
Yuan Peng, Medical Device Registration Division 1 of the CFDA
Li Jun, Director of Medical Device Registration Division 2 of the CFDA, summarily introduced “Implementation Policy of Medical Device Classification Catalogue”. She reviewed the revision history of China’s classification catalogue and made a key interpretation of the impact of the general situation of the classification catalogue and its release on the policies concerning the registration, production and operation of medical devices.
Li Jun, Director of Medical Device Registration Division 2 of the CFDA, made a speech on the “review mechanism innovative medical devices”. As of the end of November 2017, a total of 55 innovative medical devices entering the technical review process and were reviewed by a project team. The technical review of 31 innovative products was completed. The initial review time was 60% shorter than the normal review time limit. Director Jia Jianxiong interpreted the Special Examination and Approval Procedures of Innovative Medical Devices (Trial), Code of Practice for Special Examination and Approval Applications of Innovative Medical Devices, Methods for Managing the Communication of Examination and Approval of Medical Devices (Trial) and Guidelines for the Preparation of Documents for Special Examination and Approval Application of Innovative Medical Devices, and pointed that the special examination and approval innovative medical devices will be conducted by more authoritative experts with more efficiency, more transparent examination and more transparent communication.
Jia Jianxiong, Director of General Services Division, Center for Medical Device Evaluation of the CFDA
Ren Haiping, director of optic-mechanical-electric laboratory of National Institutes for Food and Drug Control made a speech entitled “New Situation and Technical Service of Medical Device Testing”. She introduced in detail the changes of the medical device inspection in Regulations on the Supervision and Administration of Medical Devices, Administrative Measures on the Qualification Accreditation of Testing Institutions, the technical services provided by NIFDC under the coexistence of challenges and opportunities.
Ren Haiping, Director of Optic-mechanical-electric Laboratory of National Institutes for Food and Drug Control
Rong Shankui, associate researcher of Standard Management Center for the Medical Devices, explained the category scope, the changes of risk management compared with the previous version and the considerations of the classification concerning laser products and ultrasound products in the new version of Medical Device Classification Catalogue based on the interpretation of Classification of Medical Device Classification Catalogue - Laser and Ultrasound Products.
Rong Shankui, Associate Researcher of Standard management center for Medical Devices of the CFDA
During the seminar, the speakers and attendees discussed the industry hotspot policy in 2017 and the content of the keynote speech, and the atmosphere of the meeting was warm and harmonious.