The SFDA has just announced a new update in the registration process of medical devices . It states that the full technical file assessment TFA will become mandatory on the low-risk medical devices (non-measuring and non-sterile). This time, they officially defined the death date of the current listing process which is simple, fast, and with low SFDA fees. We summarize the announcement in the following points:
In summary, companies must be ready to switch to the new MDMA procedure for all types of medical devices.
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