If you are doing central oxygen project, in addition to the above two certificates, but also have the relevant engineering installation qualification.
Central oxygen equipment is generally a class of mostly
Medical device registration, refers to the legal process, the proposed market sales, the use of medical devices to the safety and effectiveness of the systematic evaluation, in order to decide whether to agree with the sales, the use of the process. It is divided into the registration of medical devices within the territory and the registration of medical devices outside the territory, medical devices outside the territory, regardless of class I, class II, class III have to go to the State Food and Drug Administration in Beijing for processing: within the territory of class I, class II medical devices in the local provincial or municipal food and drug administration for processing, class III to the State Food and Drug Administration for processing.
Edit this section for the method
Related documents are & lt; medical device registration management methods & gt;, which made a detailed provision of Article 5 of the domestic production of the first class of medical devices for registration, should be submitted to the following materials: (a) proof of qualification of medical device manufacturers. (B) registered product standards and preparation instructions. (C) The full performance of the product self-test report. (D) the enterprise product production of existing resource conditions and quality management capabilities (including testing methods) of the description. (E) product instructions. (F) Self-assurance statement of the authenticity of the submitted materials. Article domestic enterprises to produce the second class, the third class of medical devices trial production registration shall submit the following materials: (A) medical device manufacturer qualification certificate. (B) product technical reports. (C) safety risk analysis report. (D) registered product standards and preparation instructions. (E) product performance self-test report. (F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registered type test report. (G) more than two clinical trial sites of clinical trial reports. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Appendix), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures". (H) product instructions. (Ix) the submitted material authenticity of the self-assurance statement. Article 7 Domestic enterprises to produce the second class, the third class of medical devices quasi-production registration shall be submitted to the following materials: (a) medical device manufacturer qualification certificate. (B) A copy of the trial production registration certificate. (C) registered product standards. (D) trial production during the product improvement report. (E) enterprise quality system assessment (certification) of valid documents. (F) the State Drug Administration recognized medical device quality testing organizations within the past year issued by the product type test report for production registration. (G) product quality tracking report. (H) submitted by the authenticity of the self-assurance statement.