Legal basis: Regulations on the Supervision and Administration of Medical Devices
Article 7 Medical device products shall meet the compulsory national standards for medical devices; If there is no mandatory national standard, it shall conform to the mandatory industry standard for medical devices.
Article 8 The State formulates plans and policies for the medical device industry, takes innovation as the development focus, gives priority to the review and approval of innovative medical devices, supports the clinical popularization and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guiding policies.
Article 9 The state improves the innovation system of medical devices, supports basic research and applied research of medical devices, promotes the popularization and application of new technologies of medical devices, and gives support in scientific and technological projects, financing, credit, bidding and purchasing, medical insurance, etc. Support enterprises to set up or jointly set up research institutions, encourage enterprises to cooperate with universities, research institutes and medical institutions to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation ability of medical devices.
Article 10 The State shall strengthen the informatization construction of medical device supervision and management, improve the online government service level, and provide convenience for the administrative licensing and filing of medical devices.
Eleventh medical device industry organizations should strengthen industry self-discipline, promote the construction of credit system, urge enterprises to carry out production and business activities according to law, and guide enterprises to be honest and trustworthy.
Twelfth units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with the relevant provisions of the state.