Q&A on Enforcement of Medical Device Production Address


Article 34 of the Measures for the Administration of Medical Device Registration stipulates: "If the following contents in the medical device registration certificate change, the production enterprise shall apply for a change and re registration within 30 days from the date of the change...


2023-03-30

Last year, China's trade deficit in vascular stents was significant


We need to continuously deepen our expansion from both product and market perspectives, innovate in materials or processes,


2023-03-30

Centralized procurement of high-value medical devices or labeling with low prices


The imported brackets with tariffs halved starting from this year may have substantial price reductions starting from this year, while the ones that truly drag down the prices of brackets that are "far away" will be centralized bidding.


2023-03-30

Emphasis on institutional construction and improvement of the regulatory system for medical devices


According to the work deployment of the Legal Affairs Office of the State Council, SFDA will continue to promote the revision of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") this year.


2023-03-30

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