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NMPA Roundup January 2023


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Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for January 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.


Surgical Robots and 36 Medical Devices Will be Tariff Free

Two major changes on medical device tariffs have been made, with two announcements from China Ministry of Finance:

  • From January 1, 2023, China has implemented a provisional import tax rate lower than the MFN (Most-Favored-Nation) rate for 1,020 commodities. Among them, 13 types of medical devices are on the list, including detachable coil, intracranial thrombectomy stent and artificial heart valve, etc.
  • From July 1, 2023, 37 types of medical devices will achieve zero import tariffs, including surgical robots, ECG therapy device, B-ultrasound diagnostic instrument, patient monitor and endoscope, etc.

Tariff heading for surgical robots has also been added to the tax catalog. Read more information.

Intellectual Property: Submitting Master File to Protect Your Raw Materials

NMPA published a notice “Further Clarify the Registration and Use of Medical Device Master Files” on January 18, 2023. It reiterates that master file system is to protect the intellectual property rights of the master file owner (raw materials’ manufacturers) and facilitates the medical device applicants’ selection of raw materials and key components, simplifying registration.

The master file is submitted directly by its owner and NMPA will review the file data when the device application begins. The submission of the master file is voluntary. Check out more information.

Guidelines & Standards

Thirty-Two Industry Standards Issued in One Day

NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

Among them, the mandatory standards include those for hemodialysis equipment, radiofrequency hyperthermia equipment, automatic non-invasive blood pressure monitor, patient monitor, pulse oximetry equipment, surgical equipment using robotic technology, etc. See the full list of the standards.

Fast-Track Approvals

2022 Innovation Approvals Review: Cardiovascular, Gastro/Urology, Neurology, and Radiology among the Most

32 innovation approvals have been granted by NMPA in 2022. Among them are eight cardiovascular and seven gastrological and urological devices. Neurological and radiological have six approvals respectively.

Overseas manufacturers who received approvals include Medtronic, Ethicon, and BioFire Diagnostics. Read our comprehensive review.

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