According to Article 19 of the Administrative Measures for the Registration of Medical Devices, if a product within the same registration unit passes the test, its safety and efficacy can represent all similar products within the registration unit. This means that a company can use the same medical device registration number to register two different brands or models of devices, as long as they belong to the same registration unit and meet the relevant testing standards.
When applying for a registration test, a company needs to submit appropriate technical information, samples and detailed product technical requirements to the testing organization. The inspection agency must have the appropriate qualifications, within the scope of its expertise to carry out testing, and product technical requirements for pre-assessment, pre-assessment results will be provided to the applicant along with the registration inspection report. For medical devices that are not included in the scope of the inspection agency, the registration and approval department will designate a suitable organization to conduct the inspection.
There are clear regulations in the clinical trial and registration process of medical devices, for example, the clinical trial should be conducted in accordance with the quality management standard in the qualified organization, and the production of samples needs to be in accordance with the requirements of the quality management system of medical devices. During the technical review, if the applicant is required to provide additional information, the applicant shall be informed of the required content in one go, and the applicant shall complete the supplementation within one year. The technical review organization has 40 working days to complete the review, and the time for the applicant to supplement the information is not counted as part of the review cycle.
Overall, the use of a medical device registration number depends on whether the product meets the requirements of the same registration unit, as well as following a rigorous inspection, clinical trial and review process.