Measures for the Administration of Registration of Medical Devices" was considered and adopted by the State Food and Drug Administration Bureau of the State Food and Drug Administration on May 28, 2004, published on August 9, 2004, and shall come into force on the date of publication.
Article I In order to standardize the management of medical device registration, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the formulation of these measures.
Second in the Chinese people *** and the territory of the sale, use of medical devices should be in accordance with the provisions of these measures to apply for registration, registration of medical devices are not authorized, shall not be sold, use.
Article III of the medical device registration, is in accordance with legal procedures, the proposed market sale, use of medical devices for systematic evaluation of safety, effectiveness, in order to decide whether or not to agree with the sale, use of the process.
Article IV of the state of medical devices to implement the classification of registration management.
The first class of medical devices within the territory of the municipal (food) drug supervision and management agencies to review and approve the issuance of medical device registration certificate.
The territory of the second class of medical devices by the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration review, approval and issue of medical device registration certificate.
The third class of medical devices within the State Food and Drug Administration review, approval and issue of medical device registration certificate.
Overseas medical devices by the State Food and Drug Administration review, approval and issue of medical device registration certificate.
Taiwan, Hong Kong, Macao, the registration of medical devices, except as otherwise provided herein, with reference to overseas medical devices.
Medical device registration certificate is valid for four years.
Article VI manufacturers of medical devices to apply for registration, bear the corresponding legal obligations, and hold a certificate of registration of medical devices after the approval of the application.
The person who handles the application for registration of medical devices shall be entrusted by the manufacturer, and has the appropriate professional knowledge, familiar with the laws, regulations, rules and technical requirements for the management of medical device registration.
Application for registration of overseas medical devices, overseas manufacturers should be designated in China as its agent, the agent shall bear the corresponding legal responsibility; and, overseas manufacturers should be entrusted with the corresponding qualifications of the legal person in China or entrusted to its institutions in China to undertake after-sales service of medical devices.
Article VII of the application for registration of medical devices, there should be applicable product standards, national standards, industry standards or the development of registered product standards, but the registered product standards shall not be lower than the national standards or industry standards.
Registered product standards should be based on the State Food and Drug Administration of medical device standards management requirements.
Article VIII of the application for registration of Class II, Class III medical devices, the manufacturer shall comply with the State Food and Drug Administration production conditions or relevant quality system requirements.