According to CoinMeta, our country has taken the lead in formulating 25 international standards in the field of medical devices. Since the beginning of this year, 7 international standard proposals in the field of medical devices put forward by our country have been approved for initiation by the International Organization for Standardization (ISO). This number represents a new high for the same period in history. To date, standards covering various aspects such as artificial intelligence medical devices, cardiovascular implants, tissue engineering medical devices, and gene sequencing have been formulated, among which 11 standards have been released, and 14 are being advanced in an orderly manner. This not only coordinates and standardizes the relevant technical content globally but also further broadens the development space for our country's biopharmaceutical industry.