Medical device supervision and management regulations - EnglishRegulations Regulations for the Supervision and Administration of Medical Devices Regulations for the Supervision and Administration o

es throughout the country. The authority shall establish a medical device registration system, a medical device standards system, a medical device testing and evaluation system, and a medical device adverse event monitoring and reporting system. The authority shall also conduct supervision and inspection of medical device production, distribution, use, and advertising activities, and shall investigate and handle any violations of these regulations. Article 5 The State encourages and supports the research and development, production, and use of innovative medical devices, and shall provide guidance and support for the development of the medical device industry. Chapter II Medical Device Registration Article 6 All medical devices produced or imported for distribution and use in China shall be registered with the drug regulatory authority under the State Council or its designated agencies. Article 7 The applicant for medical device registration shall be the manufacturer or the authorized agent of the manufacturer. The applicant shall provide complete and accurate information about the medical device, including its name, classification, composition, performance, indications, contraindications, adverse reactions, and instructions for use. Article 8 The drug regulatory authority under the State Council or its designated agencies shall conduct technical review and evaluation of the application for medical device registration within a specified period of time, and shall issue a registration certificate to those that meet the safety and effectiveness requirements. Article 9 The registration certificate for medical devices shall be valid for five years, and may be renewed upon application by the manufacturer or its authorized agent. The registration certificate may be revoked or cancelled in case of non-compliance with the regulations or upon discovery of safety risks. Chapter III Medical Device Standards Article 10 The drug regulatory authority under the State Council shall establish and revise the national standards for medical devices in accordance with the relevant laws and regulations. The standards shall cover the classification, technical requirements, testing methods, labeling, packaging, storage, transportation, and other aspects of medical devices. Article 11 The manufacturer or importer of medical devices shall comply with the national standards for medical devices, and shall ensure that their products meet the safety and effectiveness requirements. The manufacturer or importer shall also establish and implement a quality management system that conforms to the relevant standards and regulations. Article 12 The drug regulatory authority under the State Council shall conduct supervision and inspection of the implementation of the medical device standards, and shall investigate and handle any violations. Chapter IV Medical Device Testing and Evaluation Article 13 The drug regulatory authority under the State Council shall establish a medical device testing and evaluation system, which shall include the testing of safety, effectiveness, and quality of medical devices. The testing and evaluation shall be conducted by the designated testing agencies that meet the relevant requirements and standards. Article 14 The manufacturer or importer of medical devices shall submit their products for testing and evaluation as required by the regulations, and shall provide the necessary samples, technical documents, and other information. Article 15 The drug regulatory authority under the State Council shall conduct supervision and inspection of the testing and evaluation of medical devices, and shall investigate and handle any violations. Chapter V Medical Device Adverse Event Monitoring and Reporting Article 16 The drug regulatory authority under the State Council shall establish a medical device adverse event monitoring and reporting system, which shall collect and analyze the information on adverse events related to medical devices, and take appropriate measures to prevent and control the risks. Article 17 The manufacturer, importer, distributor, and user of medical devices shall report any adverse events related to the products to the drug regulatory authority under the State Council or its designated agencies in a timely and accurate manner, and shall cooperate with the investigation and follow-up actions. Article 18 The drug regulatory authority under the State Council shall conduct supervision and inspection of the reporting and handling of medical device adverse events, and shall investigate and handle any violations. Chapter VI Legal Liability Article 19 Any unit or individual that violates these regulations shall be subject to administrative penalties, including warnings, fines, confiscation of illegal income, revocation of registration certificates, and suspension or termination of business activities. In case of serious violations, criminal liabilities may also be pursued in accordance with the relevant laws. Article 20 Any unit or individual that causes harm to others due to the use of medical devices that do not meet the safety and effectiveness requirements shall bear civil liabilities in accordance with the relevant laws. Article 21 Any unit or individual that produces, distributes, or uses fake or substandard medical devices shall bear legal liabilities in accordance with the relevant laws. Chapter VII Supplementary Provisions Article 22 These regulations shall come into force on June 1, 2014. The Interim Measures for the Supervision and Administration of Medical Devices (State Council Decree No. 179) issued on December 13, 2000, shall be repealed simultaneously