Chapter I General Provisions
Article 1 The Provisions is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, with a view to standardizing the administration of medical device registration and filing and guaranteeing the safety and effectiveness of medical devices.
Article 2 All medical devices sold and used within the territory of the People's Republic of China shall apply for registration or filing according to the Provisions.
Article 3 Medical device registration refers to the prescribed procedures conducted by the food and drug regulatory department upon an application submitted by the registration applicant to decide whether the medical device to be marketed can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.
Medical device filing is a process that the filing entity submits the filing documents to the food and drug regulatory department and the food and drug regulatory department files the filing documents submitted by the filing entity.
Article 4 The medical device registration and filing shall be conducted under the principles of publicity, equity and justice.
Article 5 Class I medical device is subject to filing administration and class II and class III medical devices are subject to registration administration.
To apply for filing of class I domestic medical devices, the filing entity shall submit the filing documents to the food and drug regulatory department of the city consisting of districts .
Class II domestic medical devices shall be reviewed by the food and drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government, and the medical device registration certificate shall be issued after approval.
Class III domestic medical devices shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
To apply for filing of import class I medical devices, the filing entity shall submit the filing documents to China Food and Drug Administration.
Import class II and class III medical devices shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
The medical devices from Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China shall be registered and filed by reference to the import medical devices.
Article 6 Where a registration applicant or filing entity of a medical device brings the products to the market in his own name, he shall take responsibilities for the product.
Article 7 The food and drug regulatory department shall publicize relevant information on medical device registration and filing promptly in accordance with laws. The applicant can look up the approval progress and relevant results as well as the public can look up the result of approval.
Article 8 The State encourages the research and innovation of medical devices, implements special review for innovative medical devices, accelerates the popularization and application for new technologies of medical devices and promotes the development of medical device industry.
Chapter II Essential Requirements
Article 9 The registration applicant and filling entity of medical devices shall establish a quality management system related to product research, development and manufacture and shall keep its effective operation.
Where applying for registration of a domestic medical device subject to the special review procedures for innovative medical devices and its sample production is entrusted to another enterprise, the applicant shall entrust a medical device manufacturer having corresponding production range. Where the domestic medical device applied for registration is not subject to the special review procedures for innovative medical devices, the sample production shall not be entrusted to another enterprise.
Article 10 The persons undertaking registr...
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