SFDA Notice: 104 Industry Standards of Medical Devices Published

In the latest 3 years, nearly 300 industry standards have been published, and this is the third time to release in large-scale for the industry standards of medical devices. Industry standards are the basic technical requirements for product registration. The performance of related products shall not be lower than, but can be equal to or higher than the industry standards. National or local regulatory agencies supervise the compliance with these industry standards through type testing of registered product, approval of product standards or filling, as well as testing of sampling product in post-market and other measures. Therefore, we great recommend you give more attention to these industry standards.

We great recommend you prepare in advance, considering about 6 months’ type testing for product registration, and/or the possibility of clinical trials, and the supplementation of technical evaluation for product registration. Therefore, if you plan to apply for the registration of related products, please try to move up in advance and implement the corresponding industry standard while the preparation of R&D information, product standards and type testing for product registration.

Please pay more attention to all above and consider comprehensively from now on while you plan to promote new product to market, so as to effectively reduce risk, control cost and save time for the future product registration.