In 2018, opportunities and challenges faced by supervision of medical devices are extraordinary. Currently, the drug supervision system of China is in a special stage of deepening institutional reform. This year, China serves as the rotating chairman of International Medical Device Regulators Forum (IMDRF), and held the 13th management committee meeting of IMDRF, sounding the “Voice of China” on the “stage” of international supervision. Meanwhile, the reform of evaluation and approval system of medical devices is proceeding powerfully. Standing at a new start point and facing the new situation and new requirements, China Drug Administration held a workshop on May 3 at the Center for Medical Device Evaluation (hereinafter referred to as “CMDE”). Jiao Hong, Director of China Drug Administration, presided over the workshop, listened to the progress made in the reform of evaluation and approval system for medical devices, and studied and arranged the train of thought and emphases of next step.
Jiao Hong indicated that in accordance with the Advice on Deepening Reform of Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices issued by the General Office of the CPC Central Committee and the General Office of the State Council, a series of reform measures were successively implemented. This year, China serves as the rotating chairman of IMDRF, and at the 13th management committee meeting of IMDRF, two new work programs initiated by China, i.e. “Clinical Evaluation of Medical Devices” and “List of International Standards recognized by IMDRF Members”, were approved and determined, and became another milestone event in the supervision history of medical devices in China following the issuance and implementation of the Regulation on the Supervision and Administration of Medical Devices revised in 2014. “The breakthrough is hard-earned and means that the supervision of medical devices in China has developed from tracing, concerning and following to partial leading.” said Jiao Hong.
It is said that the reform of evaluation and approval system of medical devices continues proceeding rapidly from this year. The Registration Administration for Medical Devices of China Drug Administration, in accordance with the 2018 National Conference of Medical Device Supervision and Administration Work and the unified arrangement of China Drug Administration, researches and promotes the revision of registration regulations for medical devices and normative documents; carries out special approval for innovative and preferential medical devices, and approved 4 innovative medical devices and 2 preferentially approved products between January and April; issued the Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices, and speeds up the release course of medical devices; studies and develops measures for administration of extended clinical trials; performs the management of standards for medical devices, and preliminarily determines 97 suggestions on determination of programs; comprehensively promotes unique device identification (UDI); strengthens the classification and management of medical devices; promotes the recording of clinical trial institutions, and completed recording for 87 medical institutions by the end of April; develops check points for clinical trial of medical devices; promotes the development of the Measures for Administration of Traditional Chinese Medical Device and other support rules; performs work related to guidelines on technology examination of medical devices, and approved and issued 20 guidelines including the Guideline for Registration Technology Examination of Ophthalmic Ultrasound Diagnostic Equipment between January and April; researches and carries out supervision and spot check on registration links. Meanwhile, the relevant researches, supervision informatization and international communication as well as cooperation are well on track. China performed the work for the chairman of IMDRF and successively held the 13th management committee meeting of IMDRF in Shanghai.
“The people-centered notion shall be firmly established for the supervision of medical devices, and the work shall serve people’s healthy life.” As emphasized and indicated by Jiao Hong, currently, there is still a gap between the supervision level of medical devices in China and that in European and American developed countries. There are still problems such as inapplicability of technology evaluation on medical devices to innovative products, lack of capability reserve, slow evaluation and approval and speed, etc. Supervision of medical devices shall be a long-term work and the current work shall be well performed. We shall face challenges, promote scientific researches on supervision, trace and research the development trends of the industry, science and technology, enhance international communication, improve cooperation with colleges, universities and academic bodies, strengthen the building of supervision capability, put forth effort to build a scientific and high-efficiency evaluation and approval system, endeavor to realize “corner overtaking”, and occupy a special place in the supervision history of China on medical devices.
Jiao Hong indicated that in accordance with the Advice on Deepening Reform of Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices issued by the General Office of the CPC Central Committee and the General Office of the State Council, a series of reform measures were successively implemented. This year, China serves as the rotating chairman of IMDRF, and at the 13th management committee meeting of IMDRF, two new work programs initiated by China, i.e. “Clinical Evaluation of Medical Devices” and “List of International Standards recognized by IMDRF Members”, were approved and determined, and became another milestone event in the supervision history of medical devices in China following the issuance and implementation of the Regulation on the Supervision and Administration of Medical Devices revised in 2014. “The breakthrough is hard-earned and means that the supervision of medical devices in China has developed from tracing, concerning and following to partial leading.” said Jiao Hong.
It is said that the reform of evaluation and approval system of medical devices continues proceeding rapidly from this year. The Registration Administration for Medical Devices of China Drug Administration, in accordance with the 2018 National Conference of Medical Device Supervision and Administration Work and the unified arrangement of China Drug Administration, researches and promotes the revision of registration regulations for medical devices and normative documents; carries out special approval for innovative and preferential medical devices, and approved 4 innovative medical devices and 2 preferentially approved products between January and April; issued the Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices, and speeds up the release course of medical devices; studies and develops measures for administration of extended clinical trials; performs the management of standards for medical devices, and preliminarily determines 97 suggestions on determination of programs; comprehensively promotes unique device identification (UDI); strengthens the classification and management of medical devices; promotes the recording of clinical trial institutions, and completed recording for 87 medical institutions by the end of April; develops check points for clinical trial of medical devices; promotes the development of the Measures for Administration of Traditional Chinese Medical Device and other support rules; performs work related to guidelines on technology examination of medical devices, and approved and issued 20 guidelines including the Guideline for Registration Technology Examination of Ophthalmic Ultrasound Diagnostic Equipment between January and April; researches and carries out supervision and spot check on registration links. Meanwhile, the relevant researches, supervision informatization and international communication as well as cooperation are well on track. China performed the work for the chairman of IMDRF and successively held the 13th management committee meeting of IMDRF in Shanghai.
“The people-centered notion shall be firmly established for the supervision of medical devices, and the work shall serve people’s healthy life.” As emphasized and indicated by Jiao Hong, currently, there is still a gap between the supervision level of medical devices in China and that in European and American developed countries. There are still problems such as inapplicability of technology evaluation on medical devices to innovative products, lack of capability reserve, slow evaluation and approval and speed, etc. Supervision of medical devices shall be a long-term work and the current work shall be well performed. We shall face challenges, promote scientific researches on supervision, trace and research the development trends of the industry, science and technology, enhance international communication, improve cooperation with colleges, universities and academic bodies, strengthen the building of supervision capability, put forth effort to build a scientific and high-efficiency evaluation and approval system, endeavor to realize “corner overtaking”, and occupy a special place in the supervision history of China on medical devices.