According to the "Medical Device Registration and Record Management Measures"
Chapter VI Product Registration
Article 38 To apply for the registration of medical devices, the applicant shall, in accordance with the relevant requirements of the corresponding food and drug supervision and management departments to submit declarations.
Registration declaration shall be in Chinese. According to the foreign language translation of the declaration of information, should be provided at the same time the original. Citation of unpublished literature, should provide the owner of the information should be authorized to use the documents. Registration information should be complete, standardized, data should be true and reliable.
The applicant shall be fully responsible for the authenticity of its registration information.
Article 39 The Food and Drug Administration receives the application for formal review, and according to the following circumstances were dealt with:
(a) the application matters within the purview of the department, the declaration of information is complete, in line with the requirements of the form of review, to be accepted;
(b) declaration of information can be corrected on the spot, the error, the applicant should be allowed to correct the on-the-spot Corrections;
(C) the declaration of information is incomplete or does not meet the requirements of the formal review, the applicant should be notified within five working days of the need to correct all the contents of a late notice, since the date of receipt of the declaration of information that is admissible;
(D) the application does not fall within the purview of the department, it should be instantly notified of the inadmissibility of the applicant.
Food and Drug Administration acceptance or inadmissibility of applications for registration of medical devices, should be issued with the special seal of the department and the date of acceptance or inadmissibility notice.
Article 40 The acceptance of the application for registration of food and drug supervision and management department shall, within three working days from the date of acceptance of the declaration will be forwarded to the technical review body.
Technical review body shall within 60 working days to complete the technical review of the registration of Class II medical devices, within 90 working days to complete the technical review of the registration of Class III medical devices.
Article 41 of the Food and Drug Administration technical review body for the technical review of registration information, if necessary, access to the original research data. Review process, the need to consult experts or hold a hearing, or a combination of drugs and equipment products need to be reviewed jointly with the drug review body, the technical review body shall notify the applicant in writing, consulting experts or the time required to hold a hearing is not calculated in the prescribed time limit for the review. Combination of medicines and equipment product review time limit in accordance with relevant regulations.
Article 42 of the technical review process needs to be corrected information, the technical review body shall inform the applicant needs to be corrected all the content. The applicant shall be notified of corrections within one year from the date of receipt, in accordance with the requirements of the technical review body to provide corrective information; technical review body shall receive corrective information from the date of completion of the technical review within 60 working days. The time for the applicant to correct the information is not calculated in the review time limit.
Article 43 The applicant fails to submit corrective information after the deadline, the technical review body to accept the registration of the food and drug supervision and management department to put forward proposals to terminate the technical review, approved by the food and drug supervision and management department to make a decision on the return of the application processing, termination of the review.
Expanded Information
According to the "Measures for the Administration of Registration and Filing of Medical Devices"
Chapter III Product Technical Requirements and Registered Tests
Article 15 The applicant or the filing shall prepare the product technical requirements of the proposed registration or filing of medical devices. Product technical requirements refers to the finished medical device product performance indicators and test methods.
The product technical requirements for Class II and Class III medical devices shall be approved by the Food and Drug Administration when approving the registration. The applicant or the filer of the medical device listed in China shall comply with the product technical requirements approved or filed by the registration.
Article XVI of the medical device registration inspection refers to the medical device inspection organization in accordance with the applicant's application, based on the product technical requirements of the product inspection.
Article XVII of the application for registration of Class II, Class III medical devices should be registered. Registration of qualified products can be used for clinical trials or apply for registration.
Article XVIII of the medical device testing organizations should have medical device testing qualifications, within the scope of its inspection inspection, and the applicant to submit the product technical requirements for pre-evaluation, pre-evaluation of the opinion with the registration inspection report issued together with the applicant.
Article 19 has not been included in the scope of medical device testing organizations to undertake inspection of medical devices, by the corresponding registration and approval departments to designate the ability of the inspection agency for testing.
Order XX of the same registration unit should be able to test the product is representative of the unit of registration of other products within the safety and efficacy of typical products.
Article 21 of the registration test, the applicant shall apply in writing to the inspection agency, and provide the registration test required for the relevant technical information, registration test samples and product technical requirements.